Hyaluronic acid and herbal extract gel as an addition to cleaning of teeth for the treatment of gum disease

Phase 4

Not yet recruiting

Conditions: Chronic periodontitis,

Registration Number: CTRI/2023/08/056555

Lead Sponsor: Sibar institute of dental sciences

Brief Summary: This study will help inevaluating the efficacy of 1% Hyaluronic acid gel in combination with herbalextract gel as an adjunct to non-surgical periodontal therapy in stage â€“II periodontitis.Chronic periodontitis is an inflammatory and infectious diseases of an tissuessupporting structure of the teeth, leading to the progressive destruction ofdeep periodontal tissues. They are irreversible and are accompanied by apical migrationof junctional epithelium along the root, leading to the appearance ofperiodontal pockets and gingival recessions. Systemic antibiotics which arecurrently used in periodontics have lost their antimicrobial abilities becauseof the development of resistance.The present study is a split mouth design.Atotal of 10 patients with stage-II periodontitis will be selected into thestudy. The contralateral quadrants will be randomly divided into two groups accordingto the inclusion and exclusion criteria. Group A- Scaling and root planing and1% hyaluronic acid in combination with herbal extract gel(SRP+GEL) (n=10sites). Group B-Scaling and root planing alone (SRP) (n=10 sites).

At the initial visit, aclinical examination will be performed on each patient and Clinical parameterssuch as plaque index, gingival index, pocket depth and clinical attachmentlevel will be recorded. At Baseline all the patients will receive Non surgicalperiodontal therapy which includes Supragingival scaling and thorough oralhygiene instructions and baseline subgingival plaque sample will be collectedusing sterile curettes placed into the deepest periodontal pocket for 45sec,the collected sample will be immediately transferred to a transport medium andsent to laboratory for microbial analysis of Porphyromonas gingivalis (Pg),Aggregatibacter actinomycetemcomitans(Aa), Prevotella intermedia [Pi.],multiplex PCR. Subgingival Scaling and Root planning will be done in bothgroups (Group A and Group B) and 1% hyaluronic acid in combination with herbalextract gel will be injected into the pocket until the material is detected atthe gingival margin in Group A. Then periodontal dressing (co-pak) will beplaced on treated site to ensure that gel will stay long enough to be effectivein the pocket. After one week periodontal dressing is removed. Clinicalparameters will be recorded 3 months after treatment and post operativesubgingival plaque samples will be collected for microbial analysis from bothgroups and sent for microbiological analysis after 3 months.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

Apparently Healthy individual Subjects with stage-II periodontitis Subjects with bilaterally symmetrical clinical conditions Subjects who are willing to given informed consent.

Exclusion Criteria

Pregnancy or lactating females.
Any form of Tobacco consumption.
History of systemic diseases Previous history of any periodontal treatment before 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
probing pocket depth	Baseline&3 months

Secondary Outcome Measures

Name	Time	Method
Clinical attachment level	Plaque index

Trial Locations

Locations (1): Sibar institute of dental sciences
🇮🇳
Guntur, ANDHRA PRADESH, India
Sibar institute of dental sciences
🇮🇳Guntur, ANDHRA PRADESH, India
BHIMAVARAPU SUMANTH
Principal investigator
8500046546
sumanthbhimavarapu5@gmail.com