Trial intelligence / Profile preview

Mouthwashes for Periodontal Health in Orthodontic Patients

NCT03179735Phase 4

Key facts

Status: Unknown
Start: Jun 2017
Primary completion: Mar 2018
Countries: 1
Sponsor: Universidade de Taubaté
Modality: Conventional Liposomes, Small Molecules

Drugs: cetylpyridinium chloride
Conditions: gingivitis

Overview

Phase 4, randomised, double-blind trial of cetylpyridinium chloride in gingivitis (3 arms), sponsored by Universidade de Taubaté. Primary endpoint: Changes in gingival index at 6 months. Status: unknown.

Design

3 arms

Study design: RandomizedDouble-blind

Essential oils mouthwash
Alcohol-free mouthwash with essential oils (eucalyptol, menthol, methyl salicylate, thymol).
Cetylpyridinium mouthwash
Alcohol-free mouthwash with cetylpyridinium chloride 0.7 mg/ml.
Placebo mouthwash
Alcohol-free placebo solution.

Who it enrols

Patients with class I or II malocclusions planned for nonsurgical orthodontic treatment, with good general and periodontal health, and at least 26 natural teeth. Smokers, pregnant women, and those with systemic diseases or recent antibiotic/anti-inflammatory use are excluded.

Endpoints

Primary

Changes in gingival index6 months

Secondary

Changes in plaque index6 months
Changes in subgingival bacterial levels6 months
Changes in bracket bacterial levels6 months
Changes in gingival overgrowth measurements6 months
Corrosion of orthodontic devices6 months

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