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Completed

NCT Number: NCT04074915

Effects of Herbal Mouth Rinse for Chronic Periodontitis

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ashish Agarwal

Bareilly, Uttar Pradesh, 243122, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo mouth rinse

Other

Normal saline

Other names: NS

Chlorhexidine mouth rinse

Drug

Chlorhexidine gluconate

Other names: CHX

Test group

Drug

Chamomile mouth rinse

Other names: CMT

Primary outcomes

  1. Clinical attachment loss

    Time frame: 3 Months

    Distance from cemento enamel junction to base of the pocket

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Other

Registry information

Official study title

Effects of 1% Matricaria Chamomile Mouth Rinse for the Management of Chronic Periodontitis: a Double Blind Randomized, Placebo Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2019
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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