Effects of Herbal Mouth Rinse for Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Placebo mouth rinse
Chlorhexidine mouth rinse
Test group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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.
Sites / Locations
- Ashish Agarwal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo rinse
Chlorhexidine mouth rinse
Test group
Arm Description
Normal saline
Chlorhexidine mouth rinse
Chamomile mouth rinse
Outcomes
Primary Outcome Measures
Clinical attachment loss
Distance from cemento enamel junction to base of the pocket
Secondary Outcome Measures
Probing pocket depth
Distance from ginigval margin to base of the pocket
colony forming units
numbers of colonies of bacteria using anaerobic culture
Full Information
NCT ID
NCT04074915
First Posted
August 28, 2019
Last Updated
August 31, 2019
Sponsor
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
1. Study Identification
Unique Protocol Identification Number
NCT04074915
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo rinse
Arm Type
Placebo Comparator
Arm Description
Normal saline
Arm Title
Chlorhexidine mouth rinse
Arm Type
Experimental
Arm Description
Chlorhexidine mouth rinse
Arm Title
Test group
Arm Type
Experimental
Arm Description
Chamomile mouth rinse
Intervention Type
Other
Intervention Name(s)
Placebo mouth rinse
Other Intervention Name(s)
NS
Intervention Description
Normal saline
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouth rinse
Other Intervention Name(s)
CHX
Intervention Description
Chlorhexidine gluconate
Intervention Type
Drug
Intervention Name(s)
Test group
Other Intervention Name(s)
CMT
Intervention Description
Chamomile mouth rinse
Primary Outcome Measure Information:
Title
Clinical attachment loss
Description
Distance from cemento enamel junction to base of the pocket
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
Distance from ginigval margin to base of the pocket
Time Frame
3 Months
Title
colony forming units
Description
numbers of colonies of bacteria using anaerobic culture
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Ashish Agarwal
City
Bareilly
State/Province
Uttarpradesh
ZIP/Postal Code
243122
Country
India
12. IPD Sharing Statement
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Effects of Herbal Mouth Rinse for Chronic Periodontitis
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