Trial Outcomes & Findings for Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation (NCT NCT04187053)
NCT ID: NCT04187053
Last Updated: 2024-02-21
Results Overview
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
56 participants
Primary outcome timeframe
Baseline
Results posted on
2024-02-21
Participant Flow
Participant milestones
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
26
|
|
Overall Study
COMPLETED
|
26
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=30 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=26 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.36 years
STANDARD_DEVIATION 13.32 • n=30 Participants
|
61.03 years
STANDARD_DEVIATION 15.16 • n=26 Participants
|
62.82 years
STANDARD_DEVIATION 14.17 • n=56 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=30 Participants
|
13 Participants
n=26 Participants
|
31 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=30 Participants
|
13 Participants
n=26 Participants
|
25 Participants
n=56 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
26 participants
n=26 Participants
|
56 participants
n=56 Participants
|
|
Dental Arch
Maxillary
|
19 Participants
n=30 Participants
|
18 Participants
n=26 Participants
|
37 Participants
n=56 Participants
|
|
Dental Arch
Mandibular
|
11 Participants
n=30 Participants
|
8 Participants
n=26 Participants
|
19 Participants
n=56 Participants
|
|
Position of Implant
Anterior
|
6 Participants
n=30 Participants
|
11 Participants
n=26 Participants
|
17 Participants
n=56 Participants
|
|
Position of Implant
Posterior
|
24 Participants
n=30 Participants
|
15 Participants
n=26 Participants
|
39 Participants
n=56 Participants
|
|
Restoration Suprastructure
Single Crown
|
23 Participants
n=30 Participants
|
21 Participants
n=26 Participants
|
44 Participants
n=56 Participants
|
|
Restoration Suprastructure
Fixed Partial Denture
|
3 Participants
n=30 Participants
|
2 Participants
n=26 Participants
|
5 Participants
n=56 Participants
|
|
Restoration Suprastructure
Healing Abutment
|
1 Participants
n=30 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=56 Participants
|
|
Restoration Suprastructure
Overdentures
|
3 Participants
n=30 Participants
|
2 Participants
n=26 Participants
|
5 Participants
n=56 Participants
|
|
Periodontal Diagnosis
Gingivitis
|
15 Participants
n=30 Participants
|
10 Participants
n=26 Participants
|
25 Participants
n=56 Participants
|
|
Periodontal Diagnosis
Periodontitis
|
12 Participants
n=30 Participants
|
13 Participants
n=26 Participants
|
25 Participants
n=56 Participants
|
|
Periodontal Diagnosis
Edentulous
|
3 Participants
n=30 Participants
|
3 Participants
n=26 Participants
|
6 Participants
n=56 Participants
|
|
Width of Buccal Keratinized gingiva
|
2.37 millimeters
STANDARD_DEVIATION 0.72 • n=30 Participants
|
3.11 millimeters
STANDARD_DEVIATION 0.86 • n=26 Participants
|
2.71 millimeters
STANDARD_DEVIATION .78 • n=56 Participants
|
PRIMARY outcome
Timeframe: BaselinePeriodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=30 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=26 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Mean Probing Pocket Depth
|
4.62 millimeters
Standard Deviation 0.49
|
4.45 millimeters
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: 6 weeks post treatmentPopulation: Data were not collected for 4 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 7 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=26 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=19 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Mean Probing Pocket Depth
|
3.92 millimeters
Standard Deviation 0.63
|
3.54 millimeters
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: 12 weeks post treatmentPopulation: Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm.
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=30 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=25 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Mean Probing Pocket Depth
|
4.02 millimeters
Standard Deviation 0.66
|
3.63 millimeters
Standard Deviation 0.59
|
PRIMARY outcome
Timeframe: BaselinePopulation: Data were not collected for this outcome measure
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 weeks post treatmentPopulation: Data were not collected for this outcome measure
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 weeks post treatmentPopulation: Data were not collected for this outcome measure
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselineBleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=30 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=26 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
|
4.42 Bleeding sites
Standard Deviation 0.85
|
3.53 Bleeding sites
Standard Deviation 0.79
|
PRIMARY outcome
Timeframe: 6 weeks post treatmentPopulation: Data were not collected for 4 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 7 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=26 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=19 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
|
3.11 Bleeding sites
Standard Deviation 1.21
|
2.13 Bleeding sites
Standard Deviation 1.29
|
PRIMARY outcome
Timeframe: 12 weeks post treatmentPopulation: Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm.
Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=30 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=25 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
|
3.2 Bleeding sites
Standard Deviation 0.85
|
2.51 Bleeding sites
Standard Deviation 1.04
|
PRIMARY outcome
Timeframe: BaselinePresence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=30 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=26 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Number of Sites With Plaque Per Participant
|
4.06 sites with plaque
Standard Deviation 0.95
|
4.07 sites with plaque
Standard Deviation 1.06
|
PRIMARY outcome
Timeframe: 6 weeks post treatmentPopulation: Data were not collected for 4 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 7 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=26 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=19 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Number of Sites With Plaque Per Participant
|
3.19 sites with plaque
Standard Deviation 1.42
|
2.86 sites with plaque
Standard Deviation 1.72
|
PRIMARY outcome
Timeframe: 12 weeks post treatmentPopulation: Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm.
Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=30 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=25 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Number of Sites With Plaque Per Participant
|
3.13 sites with plaque
Standard Deviation 1.07
|
3.12 sites with plaque
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: BaselinePeriodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=30 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=26 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Max Probing Pocket Depth
|
6.16 millimeters
Standard Deviation 0.75
|
6.34 millimeters
Standard Deviation 1.31
|
PRIMARY outcome
Timeframe: 6 weeks post treatmentPopulation: Data were not collected for 4 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 7 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=26 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=19 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Max Probing Pocket Depth
|
5.23 millimeters
Standard Deviation 1.00
|
4.16 millimeters
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: 12 weeks post treatmentPopulation: Data were not collected for 1 participant in the Conventional mechanical therapy with sham aPDT treatment arm.
Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=30 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=25 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Max Probing Pocket Depth
|
5.53 millimeters
Standard Deviation 0.95
|
4.76 millimeters
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected for 13 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 10 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
Plaque samples will be taken from the deepest probing site of each implant at baseline and 12 weeks after aPDT. To assess bacteria in the sample, the V4 region of the 16S rRNA gene will be PCR amplified and sequenced, and 16S rRNA gene data will then be analyzed to determine the alpha diversity of the microbiota community at the implant site. In this study, the minimum alpha diversity is 1 and the maximum is 2501. A higher alpha diversity indicates a higher number of bacterial or taxonomic "units" in the sample.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=17 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=16 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
|
100.98 Observed Taxonomic Units (OTUs)
Standard Deviation 22.53
|
92.74 Observed Taxonomic Units (OTUs)
Standard Deviation 30.06
|
SECONDARY outcome
Timeframe: 12 weeks post treatmentPopulation: Data were not collected for 10 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 11 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
Plaque samples will be taken from the deepest probing site of each implant at baseline and 12 weeks after aPDT. To assess bacteria in the sample, the V4 region of the 16S rRNA gene will be PCR amplified and sequenced, and 16S rRNA gene data will then be analyzed to determine the alpha diversity of the microbiota community at the implant site. In this study, the minimum alpha diversity is 1 and the maximum is 2501. A higher alpha diversity indicates a higher number of bacterial or taxonomic "units" in the sample.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=20 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=15 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
|
105.11 Observed Taxonomic Units (OTUs)
Standard Deviation 29.92
|
88.68 Observed Taxonomic Units (OTUs)
Standard Deviation 25.65
|
SECONDARY outcome
Timeframe: BaselinePopulation: Samples were not tested for the presence of IL-7A, C-reactive protein, osteoprotegerin, leptin and adiponectin. Data were not collected for 24 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 22 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
PISF samples will be taken from six sites of each implant at baseline and 12 weeks after aPDT. The levels of interleukin IL-1a, IL-1b, IL-6, IL-8, IL-10, IL-12, IL-7A, tumor necrosis factor (TNF)-a, C-reactive protein, osteoprotegerin, leptin, and adiponectin will be determined using multiplex proteomic immunoassays.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=6 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=4 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-1alpha
|
74.13 picograms per milliliter
Standard Deviation 56.69
|
42.49 picograms per milliliter
Standard Deviation 5.65
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-1beta
|
391.24 picograms per milliliter
Standard Deviation 451.39
|
324.87 picograms per milliliter
Standard Deviation 415.13
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-6
|
26.05 picograms per milliliter
Standard Deviation 24.10
|
39.88 picograms per milliliter
Standard Deviation 58.02
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-8
|
1283.36 picograms per milliliter
Standard Deviation 1094.82
|
1134.66 picograms per milliliter
Standard Deviation 950.49
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-10
|
3.20 picograms per milliliter
Standard Deviation 1.04
|
2.37 picograms per milliliter
Standard Deviation 1.01
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-12
|
1.30 picograms per milliliter
Standard Deviation 0.18
|
1.37 picograms per milliliter
Standard Deviation 0.28
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
tumor necrosis factor (TNF)-alpha
|
4.06 picograms per milliliter
Standard Deviation 2.187
|
3.82 picograms per milliliter
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Samples were not tested for the presence of IL-7A, C-reactive protein, osteoprotegerin, leptin and adiponectin. Data were not collected for 24 participants in the Conventional mechanical therapy with aPDT adjunct arm. Data were not collected for 22 participants in the Conventional mechanical therapy with sham aPDT treatment arm.
PISF samples will be taken from six sites of each implant at baseline and 12 weeks after aPDT. The levels of interleukin IL-1a, IL-1b, IL-6, IL-8, IL-10, IL-12, IL-7A, tumor necrosis factor (TNF)-a, C-reactive protein, osteoprotegerin, leptin, and adiponectin will be determined using multiplex proteomic immunoassays.
Outcome measures
| Measure |
Conventional Mechanical Therapy With aPDT Adjunct
n=6 Participants
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Methylene Blue: Experimental arm will receive methylene blue
Light emitting laser: Experimental arm will receive Light emitting laser
|
Conventional Mechanical Therapy With Sham aPDT Treatment
n=4 Participants
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy
Saline: Sham group will receive saline as a sham for methylene blue
Non-light emitting laser: Sham group will receive Non-light emitting laser
|
|---|---|---|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-8
|
1691.34 picograms per milliliter
Standard Deviation 1411.79
|
1478.70 picograms per milliliter
Standard Deviation 1908.61
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-10
|
10.65 picograms per milliliter
Standard Deviation 11.28
|
3.17 picograms per milliliter
Standard Deviation 2.53
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-12
|
1.33 picograms per milliliter
Standard Deviation 0.18
|
1.30 picograms per milliliter
Standard Deviation 0.14
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
tumor necrosis factor (TNF)-alpha
|
4.53 picograms per milliliter
Standard Deviation 2.46
|
3.52 picograms per milliliter
Standard Deviation 0.46
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-1alpha
|
97.91 picograms per milliliter
Standard Deviation 52.63
|
94.97 picograms per milliliter
Standard Deviation 40.14
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-1beta
|
444.11 picograms per milliliter
Standard Deviation 478.65
|
177.13 picograms per milliliter
Standard Deviation 174.70
|
|
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
IL-6
|
24.43 picograms per milliliter
Standard Deviation 16.32
|
25.33 picograms per milliliter
Standard Deviation 31.99
|
Adverse Events
Conventional Mechanical Therapy With aPDT Adjunct
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Mechanical Therapy With Sham aPDT Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Srinivas Ayilavarapu, BDS, DSc, MDS
University of Texas Health Science Center at Houston
Phone: 713-486-4390
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place