Trial Outcomes & Findings for Effect of Non-surgical Periodontal Therapy on Gingival Crevicular Fluid Interleukin-21 Levels (NCT NCT02861937)
NCT ID: NCT02861937
Last Updated: 2020-09-02
Results Overview
Probing pocket depth (PPD) was recorded using University of North Carolina {UNC}-15 Periodontal probe and customized occlusal stent. Pocket depth was recorded from the crest of the gingival margin to the base of the pocket. The deepest probing pocket depth in the patient"s mouth was considered.
COMPLETED
NA
34 participants
6 weeks
2020-09-02
Participant Flow
Thirty four patients (19 males and 15 females, aged 20-60 years) were consecutively enrolled over a six month period (April 2014 to September 2014) from the outpatient department of periodontology, Krishnadevaraya College of Dental Sciences, Bangalore, and Karnataka.
12 chronic gingivitis, 12 chronic periodontitis patients and 10 healthy individuals were included as control. Patients systemically healthy having more than or equal to 14 functional teeth, patients had not received any form of surgical/non surgical periodontal therapy or received antibiotics within the past 6 months.
Participant milestones
| Measure |
Group I (Control Group): Healthy
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
|
Group II (Test Group I): Chronic Gingivitis
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
|
Group III (Test Group II): Chronic Periodontitis
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group I (Control Group): Healthy
n=10 Participants
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
|
Group II (Test Group I): Chronic Gingivitis
n=12 Participants
Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm, relative attachment loss (RAL) ) less than or equal to 3mm and more than to 25% sites with gingival bleeding present (BOP)
Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy
non surgical periodontal therapy: and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.
|
Group III (Test Group II): Chronic Periodontitis
n=12 Participants
Chronic periodontitis was defined as having probing depth more than or equal to 5mm, RAL more than or equal to 8mm, with more than or equal to 10% sites with BOP positive and evidence of bone loss determined radiographically.
Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy
non surgical periodontal therapy: and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 0.465 • n=10 Participants
|
25 years
STANDARD_DEVIATION 0.359 • n=12 Participants
|
44 years
STANDARD_DEVIATION 0.981 • n=12 Participants
|
33 years
STANDARD_DEVIATION 7.73 • n=34 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
6 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
15 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
6 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
19 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
10 Participants
n=10 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
34 Participants
n=34 Participants
|
PRIMARY outcome
Timeframe: 6 weeksProbing pocket depth (PPD) was recorded using University of North Carolina {UNC}-15 Periodontal probe and customized occlusal stent. Pocket depth was recorded from the crest of the gingival margin to the base of the pocket. The deepest probing pocket depth in the patient"s mouth was considered.
Outcome measures
| Measure |
Group I (Control Group)
n=10 Participants
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
|
Group II (Test Group I)
n=12 Participants
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
|
Group III (Test Group II)
n=12 Participants
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
|
|---|---|---|---|
|
Pocket Depth
|
1.60 millimetres
Standard Deviation 0.516
|
2.50 millimetres
Standard Deviation 0.522
|
6.75 millimetres
Standard Deviation 1.138
|
PRIMARY outcome
Timeframe: 6 weeksThe severity of Gingivitis was scored on the distolabial papillae, facial margins, mesiolabial papillae and entire lingual gingival margin of each tooth. A blunt instrument such as Periodontal probe was used to assess the bleeding. 0-Absence of inflammation/normal gingival 1. Mild inflammation, slight change in color, slight edema; no bleeding on probing 2. Moderate inflammation; moderate glazing, redness, edema and hypertrophy. Bleeding on probing.The higher the score,worst the outcome 3. Severe inflammation; marked redness, hypertrophy and ulceration. Tendency to spontaneous bleeding. Gingival Score Degree of gingivitis 0.1-1.0-Mild gingivitis 1.1-2.0-Moderate gingivitis 2.1-3.0-Severe gingivitis
Outcome measures
| Measure |
Group I (Control Group)
n=10 Participants
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
|
Group II (Test Group I)
n=12 Participants
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
|
Group III (Test Group II)
n=12 Participants
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
|
|---|---|---|---|
|
Gingival Index
|
0.30 units on a scale
Standard Deviation 0.041
|
1.71 units on a scale
Standard Deviation 0.465
|
2.24 units on a scale
Standard Deviation 0.359
|
PRIMARY outcome
Timeframe: 6 weeksThe surfaces examined are the four gingival areas of the tooth i,e the distolabial, facial, mesiolabial, and lingual surfaces. Mouth mirror, a light source, a dental explorer, and air drying of the teeth and gingiva were used. SCORE CRITERIA 0 No plaque in gingival area 1. No plaque can be observed by naked eye. A film of plaque adhering to the free gingival margin and adjacent area of the tooth recognized only by running a probe across the tooth surface. 2. Moderate accumulation of soft deposits within the gingival pockets or on the tooth and gingival margin, which can be seen with naked eye. 3. Abundance of soft matter within the gingival pocket and or on the tooth surface and gingival margin. The interdental area is stuffed with soft debris. Plaque Score:Oral Hygiene Status 0:Excellent 0.1-0.9:Good 1.0-1.9:Fair 2.0-3.0:Poor. The higher the value,worst is the outcome.
Outcome measures
| Measure |
Group I (Control Group)
n=10 Participants
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
|
Group II (Test Group I)
n=12 Participants
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
|
Group III (Test Group II)
n=12 Participants
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
|
|---|---|---|---|
|
Plaque Index
|
0.31 units on a scale
Standard Deviation 0.068
|
1.18 units on a scale
Standard Deviation 0.597
|
2.14 units on a scale
Standard Deviation 0.330
|
PRIMARY outcome
Timeframe: 6 weeksRAL was measured using UNC-15 periodontal probe and customized acrylic stent. This measurement was made from a fixed reference point from the occlusal surface of the acrylic stent to the base of the periodontal pocket. No Relative Attachment Level (RAL) :healthy No Relative Attachment Level (RAL) : chronic gingivitis Relative Attachment Level (RAL) more than or equal to 8mm : chronic periodontitis
Outcome measures
| Measure |
Group I (Control Group)
n=10 Participants
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
|
Group II (Test Group I)
n=12 Participants
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
|
Group III (Test Group II)
n=12 Participants
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
|
|---|---|---|---|
|
Relative Attachment Level:
|
0 millimetres
Standard Deviation 0
|
0 millimetres
Standard Deviation 0
|
9.50 millimetres
Standard Deviation 1.243
|
PRIMARY outcome
Timeframe: 6 weeksIL-21 levels in Gingival crevicular fluid {GCF} was determined by using ELISA kit. Quantikine human IL-21 immunoassay was done according to manufacturer"s instructions (MABTECH SWEDEN)®. ELISA reader was used to record the optical density of the tested samples.
Outcome measures
| Measure |
Group I (Control Group)
n=10 Participants
Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.
|
Group II (Test Group I)
n=12 Participants
Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.
|
Group III (Test Group II)
n=12 Participants
Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
|
|---|---|---|---|
|
Interleukin-21(IL-21) Cytokine Levels
|
2245.900 picogram per millilitres
Standard Deviation 771.718
|
7215.341 picogram per millilitres
Standard Deviation 1125.553
|
7390.167 picogram per millilitres
Standard Deviation 1982.4
|
Adverse Events
Group I (Control Group)
Group II (Test Group I)
Group III (Test Group II)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rudrakshi C
Krishnadevaraya college of dental sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place