Effects of Herbal Mouth Rinse for Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074915
• Other study ID #: IEC/IDS/38/2019
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: August 2019
• Source: Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Other:
• Placebo mouth rinse
Normal saline

Drug:
• Chlorhexidine mouth rinse
Chlorhexidine gluconate
• Test group
Chamomile mouth rinse

Locations

Country	Name	City	State
India	Ashish Agarwal	Bareilly	Uttarpradesh

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment loss	Distance from cemento enamel junction to base of the pocket	3 Months
Secondary	Probing pocket depth	Distance from ginigval margin to base of the pocket	3 Months
Secondary	colony forming units	numbers of colonies of bacteria using anaerobic culture	3 months