Effects of Herbal Mouth Rinse for Chronic Periodontitis

NCT ID: NCT04074915

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2019-04-15

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo rinse

Normal saline

Group Type: PLACEBO_COMPARATOR

Placebo mouth rinse

Intervention Type: OTHER

Normal saline

Chlorhexidine mouth rinse

Chlorhexidine mouth rinse

Group Type: EXPERIMENTAL

Chlorhexidine mouth rinse

Intervention Type: DRUG

Chlorhexidine gluconate

Test group

Chamomile mouth rinse

Group Type: EXPERIMENTAL

Test group

Intervention Type: DRUG

Chamomile mouth rinse

Interventions

Placebo mouth rinse

Normal saline

Intervention Type: OTHER

Chlorhexidine mouth rinse

Chlorhexidine gluconate

Intervention Type: DRUG

Test group

Chamomile mouth rinse

Intervention Type: DRUG

Other Intervention Names

NS; CHX; CMT

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

OTHER

Sponsor Role: lead

Responsible Party

ASHISH AGARWAL

Clinical professor, institute of dental sciences, bareilly

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ashish Agarwal

Bareilly, Uttar Pradesh, India

Countries

India

Other Identifiers

IEC/IDS/38/2019

Identifier Type: -

Identifier Source: org_study_id