Mouthwashes During Orthodontic Treatment

NCT03179735 | Unknown Phase 4 DMC

• 1 other identifier: MOUORT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The number of orthodontic treatment provided to Brazilian population has been increased. Unfortunately, some negative effects such as gum bleeding and bad breath are commonly observed. It partially happens because tooth brushing and flossing become more difficult in the presence of braces. Therefore, there is a need for clinical protocols able to maintain the mouth healthy during orthodontic treatment. Considering that proper use of mouthwashes by in individuals without braces is accompanied by decrease in plaque and gum inflammation levels, it was hypothesized that, during orthodontic treatment their anti-gingivitis and anti-plaque properties would positively affect oral health. Objectives: The present study will compare the effects of two commercially available mouthwashes with a placebo mouthwash in orthodontic patients wearing fixed appliances. Whole-mouth clinical examinations will be performed in periodontally healthy patients 15 days before, at the day of bonding and also 3 and 6 months after braces bonding. Hard and soft tissues status, presence of gingivitis and amount of dental plaque will be monitored to determine mouthwashes efficacy. At these same time-points plaque samples will be collected from dental sites and braces surfaces aiming at determining total levels of bacteria and levels of specific bacteria related to gum disease. After a full-mouth ultrasonic debridement to remove dental plaque, stains and tartar, patients will be randomly assigned to an Essential oils, Cetylpyridinium chloride or a placebo mouthwash for 6 months (40 ml/day). Further, samples of orthodontic wires will be analyzed under microscopy to check whether regular use of mouthwashes increases the risk of corrosion or not.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Changes in gingival index

  Gingival index changes (mean scores) from baseline to 6 months.

  up to 6 months

Secondary Outcomes (5)

• Changes in plaque index

  up to 6 months

• Changes in subgingival bacterial levels

  up to 6 months

• Changes in bracket bacterial levels

  up to 6 months

• Changes in gingival overgrowth measurements

  up to 6 months

• Corrosion of orthodontic devices

  up to 6 months

Study Arms (3)

Essential oils mouthwash

EXPERIMENTAL

Essential-oils group will rinse with an alcohol-free mouthwash (twice daily use; 20 ml/30 s) containing a fixed combination of four essential oils (eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%)

Drug: Essential oils

Cetylpyridinium mouthwash

EXPERIMENTAL

Cetylpyridinium chloride group will rinse with an alcohol-free mouthwash (twice daily use; 20 ml/30 s) containing cetylpyridinium chloride 0.7 mg/ml

Drug: Cetylpyridinium Chloride 0.7 mg/ml

Placebos mouthwash

PLACEBO COMPARATOR

Placebo group will rinse with an alcohol-free placebo solution (twice daily use; 20 ml/30 s)

Drug: Placebos

Interventions

Essential oils DRUG

Patients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home. First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding.

Essential oils mouthwash

Cetylpyridinium Chloride 0.7 mg/ml DRUG

Patients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home. First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding.

Cetylpyridinium mouthwash

Placebos DRUG

Patients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home. First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding.

Placebos mouthwash

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• good general health;
• class I or class II malocclusions with a nonsurgical orthodontic treatment plan for alignment and leveling including no-extraction, extraction of two upper premolars or extraction of four premolars; no previous orthodontic treatment; overbite and overjet that allowed brackets to be placed on the lower teeth without occlusal interferences;
• periodontal health (with no clinical signals of inflammation, GI \<1 e no clinical attachment loss);
• at least 26 natural teeth;

You may not qualify if:

• severe skeletal malocclusion in anteroposterior, vertical or transverse dimensions; surgical orthodontic plan;
• mouth breathing;
• gingivitis; periodontitis; gingival overgrowth;
• prosthetic fixed devices, removable partial dentures or overhanging restorations;
• systemic diseases or conditions that could influence the periodontal status;
• smokers and former-smokers;
• pregnancy or breast-feeding;
• history of sensitivity or suspected allergies following the use of oral hygiene products; any antibiotic prophylaxis;
• antibiotics and/or anti-inflammatory drug use in the six months prior to the beginning of the study;
• regular use of chemotherapeutic antiplaque/antigingivitis products;
• periodontal treatment performed within six months prior to study initiation;
• unwillingness to return for follow-up.

Sponsors & Collaborators

• University of Taubate: lead

Study Sites (1)

Nucleus of periodontal research of University of Taubate

Taubaté, São Paulo, 12020330, Brazil

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Oils, Volatile; Cetylpyridinium

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sheila C Cortelli, PhD

  Dean periodontics department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 7, 2017
• Study Start: June 1, 2017
• Primary Completion: March 10, 2018
• Study Completion: July 10, 2018
• Last Updated: June 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)