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Effects of Herbal Mouth Rinse for Chronic Periodontitis

I

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Status

Completed

Conditions

Chronic Periodontitis

Treatments

Drug: Chlorhexidine mouth rinse
Other: Placebo mouth rinse
Drug: Test group

Study type

Interventional

Funder types

Other

Identifiers

NCT04074915
IEC/IDS/38/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

75 participants in 3 patient groups, including a placebo group

Placebo rinse
Placebo Comparator group
Description:
Normal saline
Treatment:
Other: Placebo mouth rinse
Chlorhexidine mouth rinse
Experimental group
Description:
Chlorhexidine mouth rinse
Treatment:
Drug: Chlorhexidine mouth rinse
Test group
Experimental group
Description:
Chamomile mouth rinse
Treatment:
Drug: Test group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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