Effect of Non-surgical Periodontal Therapy on Gingival Crevicular Fluid Interleukin-21 Levels

NCT02861937 | Completed Results

• 1 other identifier: 02-D012-36773
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

Human IL-21 is present in gingival crevicular fluid in periodontal health, gingivitis and chronic periodontitis. A significant increase in the concentration of IL-21 in gingival crevicular fluid is observed with an increase in the amount of periodontal destruction. Non- surgical periodontal therapy aided in decrease of GCF IL-21 levels in clinical gingivitis and chronic periodontitis

Conditions

Chronic Peridontitis Patients; Chronic Gingivitis; Healthy

Outcome Measures

Primary Outcomes (5)

• Pocket Depth

  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.

  6 weeks

• Gingival Index

  The 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

  6 weeks

• Plaque Index

  The 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.

  6 weeks

• Relative Attachment Level:

  RAL 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

  6 weeks

• Interleukin-21(IL-21) Cytokine Levels

  IL-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.

  6 weeks

Study Arms (3)

healthy

NO INTERVENTION

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. As there was no attachment loss, it was not necessary for us to calculate RAL ( Relative Attachment Level)

chronic gingivitis

ACTIVE COMPARATOR

Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm and more than to 25% sites with the gingival bleeding present (BOP) As there was no attachment loss, it was not necessary for us to calculate RAL ( Relative Attachment Level) Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy

Procedure: non surgical periodontal therapy

chronic periodontitis

ACTIVE COMPARATOR

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

Procedure: non surgical periodontal therapy

Interventions

non surgical periodontal therapy PROCEDURE

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.

chronic gingivitis; chronic periodontitis

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients having more than or equal to 14 functional teeth, systemically healthy patients who had not received any form of surgical and non surgical periodontal therapy or received antibiotics or non-steroidal anti-inflammatory

You may not qualify if:

• smokers pregnant females

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Limitations and Caveats

This study needs to be elucidated with larger sample size and for longer duration, on arresting periodontal disease progression/disease activity by assessing the IL-21 levels.

Results Point of Contact

• Title: Dr. Rudrakshi C
• Organization: Krishnadevaraya college of dental sciences

drrudrakshi@rediffmail.com

080-28467083

Study Officials

• Rudrakshi Chickanna, MDS

  Krishnadevaraya college of dental sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 34 patients with 19 males and 15 females in the age group of 20-60 years were included. Patients were divided into 3 groups to collect Gingival Crevicular Fluid (GCF) samples for the study.

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: August 10, 2016
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 2, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share