Herbal mouthwash for bleeding gums and plaque control

Phase 1/2

Not yet recruiting

• Conditions: Other infectious disease,

• Registration Number: CTRI/2018/11/016395
• Lead Sponsor: National innovation Foundation

Brief Summary

The aim of the present study is to evaluate the efficacy of herbal mouthwashes with chlorhexidine mouthwash in patients with mild to moderate gingivitis for reduction of plaque and gingivitis scores, Microbial counts and salivary pH reduction and to assess patient acceptance (irritation of taste, subjective tooth staining). One hundred twenty individuals with chronic generalized gingivitis will be randomly assigned to three groups: 1) group I, Chlorhexidine mouthwash; 2) group II, Herbal mouthwash A; and 3) group III, Herbal mouthwash B. All individuals will be instructed to rinse with 15 ml of their respective mouthwash twice daily. 1) plaque index (PI); 2) gingival index (GI); 3) oral hygiene index-simplified (OHI-S); and 4) microbiologic colony counts will be recorded at baseline and at 7, 30, and 60 days.

Subsequent to baseline estimation (set 1), each participant will undergo two sets of saliva sample collection along with estimation of salivary pH in two phases: Ten minutes after the mouthrinse (set 2), and 60 min after the mouthrinse (set 3).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-11-16
• Study Start: 2019-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• After taking a detailed medical history and initial clinical and radiologic examination, systemically healthy individuals of an age range of 18-40 years with previously untreated gingivitis and greater than or equal to 20 teeth with no visible signs of untreated dental caries will be selected.
• Clinical parameters for inclusion will be: 1) gingival index (GI) greater than 1; 2) probing depth less than equal to 3 mm; 3) clinical attachment loss should be 0, with no evidence of radiographic bone loss.
• Absence of bone loss will be considered when the distance between cemento-enamel junction and crestal bone is less than equal to 1 mm.

Exclusion Criteria

1. Use of antibiotics and anti-inflammatory drugs in previous 6 months; 2) individuals with orthodontic appliances or prosthetic appliances that would interfere with evaluation and plaque control; 3) allergy to any ingredient used in the study; 4) alcoholics; 5) smokers or users of tobacco in any form; 6) individuals with mental retardation or medical illness; 7) Use of mouthwashes and vitamin supplements in last 3 months; 8)History of any periodontal therapy in last months; and 7) pregnant or lactating females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of gingival and plaque indices	Baseline, 1 week, 1 month, 2 months

Secondary Outcome Measures

Name	Time	Method
Microbial count.	Baseline-7 days-30 days-60 days
Patient acceptance (irritation of taste, subjective tooth staining)	60 days

Trial Locations

Locations (1)

Centre for Dental Education and Research; 🇮🇳 West, DELHI, India

Centre for Dental Education and Research

🇮🇳West, DELHI, India

Dr O P Kharbanda

Principal investigator

9899062144

opk15@hotmail.com