Effects of Herbal Mouth Rinse for Chronic Periodontitis

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Other: Placebo mouth rinse; Drug: Test group; Drug: Chlorhexidine mouth rinse

• Registration Number: NCT04074915
• Lead Sponsor: Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Brief Summary

This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month while clinical parameters \[plaque index (PI), gingival index (GI), sulcus bleeding index (SBI), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), stain index (SI)\] were evaluated at base line, 1 month, and 3 months. CFU was also evaluating at above said time periods.

Detailed Description

This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month.The primary outcome of this study was CAL, while PPD was the secondary outcome measure. A single clinician (AA) who was blinded to the groups assigned to the individuals, recorded all the parameters i.e. PI, GI, SBI, PPD, CAL, GR, SI at base line (prior to the treatment), 1 and 3 months after therapy. PPD, CAL and GR were recorded at the six sites per tooth in every tooth, except third molar, with a manual UNC-15 periodontal probe (Hu-Friedy, Leinmen, Germany) to the nearest millimeter. For recording of parameters at different time periods patients were instructed to refrain from any oral hygiene procedure for 8 hours prior to the evaluation. Staining of the six maxillary anterior teeth was assessed using the Lobene index. CFUs of P. ginigvalis, T. forsythia, and T. denticola were evaluated at baseline , 1 months, 3 months.

Study Timeline

• Study Start: 2018-12-20
• Primary Completion: 2019-04-15
• Study Completion: 2019-04-15
• Status Verified: 2019-08
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Last Update Submitted: 2019-08-31
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• systemically healthy individuals of > 30 years of age with previously untreated generalized chronic periodontitis (defined by Armitage in 1999),
• having minimum 15 teeth,
• minimum of six teeth with at least one interproximal site with PPD between 5-7mm,
• CAL between 5-10 mm, at least 30% of the sites with PPD and CAL ≥ 5 mm
• presence of bleeding on probing (BOP).

Exclusion Criteria

• was any systemic disease,
• use of any medication in the previous 6 months,
• subjects wearing partial removal prosthesis or orthodontic appliance,
• allergy to ingredient used in the study, alcoholics, smokers or tobacoo users in any form, mentally retarded individual, pregnant or lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo rinse	Placebo mouth rinse	Normal saline
Test group	Test group	Chamomile mouth rinse
Chlorhexidine mouth rinse	Chlorhexidine mouth rinse	Chlorhexidine mouth rinse

Primary Outcome Measures

Name	Time	Method
Clinical attachment loss	3 Months	Distance from cemento enamel junction to base of the pocket

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth	3 Months	Distance from ginigval margin to base of the pocket
colony forming units	3 months	numbers of colonies of bacteria using anaerobic culture

Trial Locations

Locations (1)

Ashish Agarwal; 🇮🇳 Bareilly, Uttarpradesh, India