Effects of Herbal Mouth Rinse for Chronic Periodontitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Other: Placebo mouth rinse
* Drug: Chlorhexidine mouth rinse
* Drug: Test group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo rinse<br>Normal saline | Other: Placebo mouth rinse<br>* Normal saline<br>* Other names: NS;|
| Experimental: Chlorhexidine mouth rinse<br>Chlorhexidine mouth rinse | Drug: Chlorhexidine mouth rinse<br>* Chlorhexidine gluconate<br>* Other names: CHX;|
| Experimental: Test group<br>Chamomile mouth rinse | Drug: Test group<br>* Chamomile mouth rinse<br>* Other names: CMT;|

What is the study measuring?
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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 |