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
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2019
CompletedFirst Submitted
Initial submission to the registry
August 28, 2019
CompletedFirst Posted
Study publicly available on registry
August 30, 2019
CompletedSeptember 4, 2019
August 1, 2019
4 months
August 28, 2019
August 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical attachment loss
Distance from cemento enamel junction to base of the pocket
3 Months
Secondary Outcomes (2)
Probing pocket depth
3 Months
colony forming units
3 months
Study Arms (3)
Placebo rinse
PLACEBO COMPARATORNormal saline
Chlorhexidine mouth rinse
EXPERIMENTALChlorhexidine mouth rinse
Test group
EXPERIMENTALChamomile mouth rinse
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ashish Agarwal
Bareilly, Uttar Pradesh, 243122, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor, institute of dental sciences, bareilly
Study Record Dates
First Submitted
August 28, 2019
First Posted
August 30, 2019
Study Start
December 20, 2018
Primary Completion
April 15, 2019
Study Completion
April 15, 2019
Last Updated
September 4, 2019
Record last verified: 2019-08