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Effects of Herbal Mouth Rinse for Chronic Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074915
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
ASHISH AGARWAL, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Other: Placebo mouth rinse Drug: Chlorhexidine mouth rinse Drug: Test group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of 1% Matricaria Chamomile Mouth Rinse for the Management of Chronic Periodontitis: a Double Blind Randomized, Placebo Controlled Clinical Trial
Actual Study Start Date : December 20, 2018
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : April 15, 2019


Arm Intervention/treatment
Placebo Comparator: Placebo rinse
Normal saline
Other: Placebo mouth rinse
Normal saline
Other Name: NS

Experimental: Chlorhexidine mouth rinse
Chlorhexidine mouth rinse
Drug: Chlorhexidine mouth rinse
Chlorhexidine gluconate
Other Name: CHX

Experimental: Test group
Chamomile mouth rinse
Drug: Test group
Chamomile mouth rinse
Other Name: CMT




Primary Outcome Measures :
  1. Clinical attachment loss [ Time Frame: 3 Months ]
    Distance from cemento enamel junction to base of the pocket


Secondary Outcome Measures :
  1. Probing pocket depth [ Time Frame: 3 Months ]
    Distance from ginigval margin to base of the pocket

  2. colony forming units [ Time Frame: 3 months ]
    numbers of colonies of bacteria using anaerobic culture



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074915


Locations
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India
Ashish Agarwal
Bareilly, Uttarpradesh, India, 243122
Sponsors and Collaborators
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
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Responsible Party: ASHISH AGARWAL, Clinical professor, institute of dental sciences, bareilly, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
ClinicalTrials.gov Identifier: NCT04074915    
Other Study ID Numbers: IEC/IDS/38/2019
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants