Trial Outcomes & Findings for Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients (NCT NCT02466646)
NCT ID: NCT02466646
Last Updated: 2020-06-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
6 months after initial periodontal treatment
Results posted on
2020-06-09
Participant Flow
Total of 54 subjects were assessed for eligibility. Prior to assignment of participants, 2 subjects declined to participate and 10 participants were not meeting inclusion criteria
Participant milestones
| Measure |
Full-mouth Disinfection IPT
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients
Baseline characteristics by cohort
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.64 years
STANDARD_DEVIATION 5.65 • n=5 Participants
|
29.86 years
STANDARD_DEVIATION 6.41 • n=7 Participants
|
31.86 years
STANDARD_DEVIATION 4.56 • n=5 Participants
|
29.45 years
STANDARD_DEVIATION 5.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months after initial periodontal treatmentOutcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Probing Depth
Baseline Probing Depth (PD)
|
4.55 mm
Standard Deviation 0.72
|
4.80 mm
Standard Deviation 0.62
|
4.90 mm
Standard Deviation 0.62
|
|
Probing Depth
6th month PD
|
2.71 mm
Standard Deviation 0.29
|
3.40 mm
Standard Deviation 0.50
|
3.04 mm
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentOutcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
3rd month IL-1β
|
2.07 Picogram
Standard Deviation 0.51
|
2.11 Picogram
Standard Deviation 0.39
|
2.06 Picogram
Standard Deviation 0.24
|
|
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
Baseline Interleukin-1β
|
2.53 Picogram
Standard Deviation 0.39
|
2.27 Picogram
Standard Deviation 0.62
|
2.15 Picogram
Standard Deviation 0.64
|
|
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
6th month IL-1β
|
2.11 Picogram
Standard Deviation 0.55
|
1.90 Picogram
Standard Deviation 0.49
|
1.96 Picogram
Standard Deviation 0.47
|
|
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
Baseline Interleukin-17
|
18.53 Picogram
Standard Deviation 7.29
|
19.91 Picogram
Standard Deviation 10.68
|
19.67 Picogram
Standard Deviation 7.60
|
|
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
3rd month IL-17
|
21.07 Picogram
Standard Deviation 10.94
|
21.02 Picogram
Standard Deviation 9.94
|
19.76 Picogram
Standard Deviation 4.83
|
|
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
6th month IL-17
|
20.05 Picogram
Standard Deviation 7.49
|
19.27 Picogram
Standard Deviation 7.56
|
18.46 Picogram
Standard Deviation 4.61
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentOutcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Level of A. Actinomycetemcomitans
6th month A. actinomycetemcomitans level
|
2.92 log10(cells/ml)
Standard Deviation 0.64
|
3.59 log10(cells/ml)
Standard Deviation 1.10
|
3.47 log10(cells/ml)
Standard Deviation 1.21
|
|
Level of A. Actinomycetemcomitans
Baseline A. actinomycetemcomitans level
|
3.65 log10(cells/ml)
Standard Deviation 1.21
|
3.84 log10(cells/ml)
Standard Deviation 1.20
|
3.63 log10(cells/ml)
Standard Deviation 1.26
|
|
Level of A. Actinomycetemcomitans
3rd months A. actinomycetemcomitans level
|
3.27 log10(cells/ml)
Standard Deviation 0.71
|
3.73 log10(cells/ml)
Standard Deviation 1.28
|
3.47 log10(cells/ml)
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentOutcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Level of Porphyromonas Gingivalis
Baseline P. gingivalis level
|
4.64 log10(cells/ml)
Standard Deviation 1.47
|
5.50 log10(cells/ml)
Standard Deviation 0.71
|
5.47 log10(cells/ml)
Standard Deviation 1.06
|
|
Level of Porphyromonas Gingivalis
3rd months P. gingivalis level
|
2.90 log10(cells/ml)
Standard Deviation 0.50
|
3.60 log10(cells/ml)
Standard Deviation 1.15
|
3.74 log10(cells/ml)
Standard Deviation 1.05
|
|
Level of Porphyromonas Gingivalis
6th month P. gingivalis level
|
3.25 log10(cells/ml)
Standard Deviation 0.98
|
4.00 log10(cells/ml)
Standard Deviation 1.13
|
3.84 log10(cells/ml)
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentOutcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Level of Fusobacterium Nucleatum
Baseline F. nucleatum level
|
4.67 log10(cells/ml)
Standard Deviation 0.66
|
4.78 log10(cells/ml)
Standard Deviation 0.45
|
4.66 log10(cells/ml)
Standard Deviation 0.51
|
|
Level of Fusobacterium Nucleatum
3rd month F. nucleatum level
|
3.84 log10(cells/ml)
Standard Deviation 0.55
|
3.99 log10(cells/ml)
Standard Deviation 0.76
|
4.42 log10(cells/ml)
Standard Deviation 0.68
|
|
Level of Fusobacterium Nucleatum
6th month F. nucleatum level
|
3.73 log10(cells/ml)
Standard Deviation 1.00
|
3.84 log10(cells/ml)
Standard Deviation 1.03
|
4.17 log10(cells/ml)
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentOutcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Level of Parvimonas Micra
3rd month P. micra level
|
4.22 log10(cells/ml)
Standard Deviation 0.49
|
4.34 log10(cells/ml)
Standard Deviation 0.43
|
4.51 log10(cells/ml)
Standard Deviation 0.52
|
|
Level of Parvimonas Micra
Baseline P. micra level
|
4.96 log10(cells/ml)
Standard Deviation 0.50
|
4.86 log10(cells/ml)
Standard Deviation 0.45
|
4.70 log10(cells/ml)
Standard Deviation 0.58
|
|
Level of Parvimonas Micra
6th month P. micra level
|
4.28 log10(cells/ml)
Standard Deviation 0.63
|
4.30 log10(cells/ml)
Standard Deviation 0.58
|
4.43 log10(cells/ml)
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentPossible score for BOP range from %0 (no sites with bleeding on probing) to %100 (all sites with bleeding on probing). Higher scores mean worse outcome.
Outcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Bleeding on Probing
Baseline Bleeding on Probing (BOP)
|
78.30 percentage of BOP positive sites
Standard Deviation 15.05
|
89.28 percentage of BOP positive sites
Standard Deviation 9.03
|
85.77 percentage of BOP positive sites
Standard Deviation 13.49
|
|
Bleeding on Probing
3rd month BOP
|
38.87 percentage of BOP positive sites
Standard Deviation 7.15
|
54.43 percentage of BOP positive sites
Standard Deviation 14.80
|
48.90 percentage of BOP positive sites
Standard Deviation 10.47
|
|
Bleeding on Probing
6th month BOP
|
42.78 percentage of BOP positive sites
Standard Deviation 5.91
|
60.19 percentage of BOP positive sites
Standard Deviation 16.33
|
49.74 percentage of BOP positive sites
Standard Deviation 13.03
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentPossible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome
Outcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Plaque Index
Baseline PI
|
1.51 score on a scale
Standard Deviation 0.28
|
1.76 score on a scale
Standard Deviation 0.31
|
1.62 score on a scale
Standard Deviation 0.20
|
|
Plaque Index
3rd month PI
|
0.67 score on a scale
Standard Deviation 0.12
|
0.69 score on a scale
Standard Deviation 0.18
|
0.84 score on a scale
Standard Deviation 0.13
|
|
Plaque Index
6th month PI
|
0.72 score on a scale
Standard Deviation 0.16
|
0.77 score on a scale
Standard Deviation 0.20
|
0.82 score on a scale
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentPossible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome
Outcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Gingival Index
Baseline GI
|
1.61 score on a scale
Standard Deviation 0.28
|
1.80 score on a scale
Standard Deviation 0.22
|
1.74 score on a scale
Standard Deviation 0.23
|
|
Gingival Index
3rd month GI
|
1.17 score on a scale
Standard Deviation 0.10
|
1.15 score on a scale
Standard Deviation 0.29
|
1.24 score on a scale
Standard Deviation 0.09
|
|
Gingival Index
6th month GI
|
1.20 score on a scale
Standard Deviation 0.06
|
1.29 score on a scale
Standard Deviation 0.21
|
1.21 score on a scale
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentOutcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Clinical Attachment Level
Baseline Clinical Attachment Level (CAL)
|
5.20 mm
Standard Deviation 0.93
|
5.67 mm
Standard Deviation 1.24
|
5.79 mm
Standard Deviation 0.67
|
|
Clinical Attachment Level
3rd month CAL
|
4.54 mm
Standard Deviation 0.75
|
4.94 mm
Standard Deviation 1.24
|
5.10 mm
Standard Deviation 0.75
|
|
Clinical Attachment Level
6th month CAL
|
4.51 mm
Standard Deviation 0.69
|
5.25 mm
Standard Deviation 1.37
|
5.13 mm
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentOutcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Level of Prevotella Intermedia
Baseline P. intermedia level
|
4.24 log10(cells/ml)
Standard Deviation 1.07
|
5.51 log10(cells/ml)
Standard Deviation 0.86
|
4.84 log10(cells/ml)
Standard Deviation 0.98
|
|
Level of Prevotella Intermedia
3rd month P. intermedia level
|
2.73 log10(cells/ml)
Standard Deviation 0.79
|
3.70 log10(cells/ml)
Standard Deviation 1.20
|
3.81 log10(cells/ml)
Standard Deviation 1.40
|
|
Level of Prevotella Intermedia
6th month P. intermedia level
|
2.98 log10(cells/ml)
Standard Deviation 0.75
|
4.14 log10(cells/ml)
Standard Deviation 1.19
|
3.46 log10(cells/ml)
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 months after initial periodontal treatmentOutcome measures
| Measure |
Full-mouth Disinfection IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).
|
Conventional IPT
n=14 Participants
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
|
Full-mouth IPT
n=14 Participants
Initial periodontal treatment was performed in 2 sessions within 24 hours.
|
|---|---|---|---|
|
Level of Campylobacter Rectus
Baseline C. rectus level
|
5.95 log10(cells/ml)
Standard Deviation 0.70
|
6.19 log10(cells/ml)
Standard Deviation 0.60
|
5.99 log10(cells/ml)
Standard Deviation 0.72
|
|
Level of Campylobacter Rectus
3rd month C. rectus level
|
4.63 log10(cells/ml)
Standard Deviation 0.79
|
5.01 log10(cells/ml)
Standard Deviation 1.04
|
5.25 log10(cells/ml)
Standard Deviation 0.87
|
|
Level of Campylobacter Rectus
6th month C. rectus level
|
4.64 log10(cells/ml)
Standard Deviation 0.82
|
4.99 log10(cells/ml)
Standard Deviation 1.15
|
5.03 log10(cells/ml)
Standard Deviation 0.93
|
Adverse Events
Full-mouth Disinfection IPT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional IPT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Full-mouth IPT
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
Prof. Dr. Basak Dogan
Marmara University Faculty of Dentistry, Department of Periodontology
Phone: 00905332621170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place