Clinical trial NCT04074915: Effects of Herbal Mouth Rinse for Chronic Periodontitis
Official title: Effects of 1% Matricaria Chamomile Mouth Rinse for the Management of Chronic Periodontitis: a Double Blind Randomized, Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical attachment loss
timeFrame: 3 Months
Secondary outcomes:
measure: Probing pocket depth
timeFrame: 3 Months
measure: colony forming units
timeFrame: 3 months
Other outcomes:
Locations:
city: Bareilly
country: India
facility: Ashish Agarwal
state: Uttarpradesh
Study officials:
References: