Clinical Trials Directory

Trials / Completed

CompletedNCT04074915

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India · Academic / Other
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPlacebo mouth rinseNormal saline
DRUGChlorhexidine mouth rinseChlorhexidine gluconate
DRUGTest groupChamomile mouth rinse

Timeline

Start date
2018-12-20
Primary completion
2019-04-15
Completion
2019-04-15
First posted
2019-08-30
Last updated
2019-09-04

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT04074915. Inclusion in this directory is not an endorsement.