A study comparing the ability of a herbal extract along with cleaning of patients with gum dissorders

Phase 1

Completed

• Conditions: Chronic periodontitis patients

• Registration Number: CTRI/2018/03/012278
• Lead Sponsor: Krishnapriya

Brief Summary

Thissplit- mouth study was conducted in 30 chronic periodontitis patients withpersisting deep periodontal pockets of 30-65 years of age at the Department ofPeriodontics, Coorg Institute of Dental Sciences Virajpet to evaluate the efficacy of scalingand root planing (SRP) and local drug delivery of 3D Hydrogel containingextracts of Centella Asiatica inchronic generalized periodontitis patients. The 3D gel was applied to pocketbase of experimental sites by gently inserting the tip of applicator. Over thefollowing 3 weeks the experimental sites received additional sub-gingival geladministration once a week whereas control site received scaling and rootplaning.Collection of GCF and plaque sample collection weredone at 6, 10, 14, 18 weeks (4months after initial treatment) along withclinical parameters and the samples collected were subjected to BAPNA(Nα-Benzoyl-DL-Arginine-p-Nitroanilide assay) to determine trypsin likeactivity of Red complex micro-organisms.

Analysisof variance (One Way Repeated ANOVA) was performed as a parametric test tocompare the two groups. The clinical parameters were evaluated by usingunpaired t-test.

Fromthe results obtained from this study, all the clinical parameters showed asignificant reduction from baseline to 6week in both test (SRP+MED) and controlgroup (SRP alone).

TheBAPNA values also showed significant reduction from baseline to 6 weeks when inboth groups.

Thevalues of clinical parameters showed a statistically non-significant resultswhen both groups were compared.

Therewas a reverse trend in both values of clinical and BAPNA values after 10thweek.

Hence,within the limitations of the study, it can be concluded that, 3 D hydrogel as an adjunct to SRP is an effectivetreatment method but not superior to SRP. Sub-gingivally delivered geldemonstrated a safety profile with no major common untoward allergic, local orsystemic effect.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-03
• Study Completion: 2019-06-19
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients diagnosed with chronic periodontitis with pocket depth ≥ 5 mm and having good systemic health.
• 2)Age of 30 years or older.
• 3)Minimum sixteen teeth present 4)Test tooth must have a neighbouring teeth (mesial and distal).

Exclusion Criteria

• 1)Any Systemic illness 2)Smoking & patients using other forms of tobacco.
• 3)Pregnant or lactating women.
• 4)Systemic antibiotics within the previous 2 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
expecting reduction in probing pocket depth in the region of local delivery of drug.	baseline 6th 10th 14th 18th weeks

Secondary Outcome Measures

Name	Time	Method
Reduction in periodontal infection and good oral health	baseline 6th 10th 14th 18th weeks

Trial Locations

Locations (1)

Coorg Institute Of Dental Sciences; 🇮🇳 Kodagu, KARNATAKA, India

Coorg Institute Of Dental Sciences

🇮🇳Kodagu, KARNATAKA, India

Krishnapriya

Principal investigator

8277384414

krishnapriya126kp@gmail.com