Effects of Herbal Mouth Rinse for Chronic Periodontitis

Effects of 1% Matricaria Chamomile Mouth Rinse for the Management of Chronic Periodontitis: a Double Blind Randomized, Placebo Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Other: Placebo mouth rinse; Drug: Chlorhexidine mouth rinse; Drug: Test group

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Uttarpradesh
    • Bareilly, Uttarpradesh, India, 243122
      • Ashish Agarwal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo rinse; Normal saline	Other: Placebo mouth rinse; Normal saline; Other Names: NS
Experimental: Chlorhexidine mouth rinse	Drug: Chlorhexidine mouth rinse; Chlorhexidine gluconate; Other Names: CHX
Experimental: Test group; Chamomile mouth rinse	Drug: Test group; Chamomile mouth rinse; Other Names: CMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment loss	Distance from cemento enamel junction to base of the pocket	3 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 31, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: IEC/IDS/38/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No