NCT03179735

Mouthwashes During Orthodontic Treatment

Mouthwashes as Positive Modulators of Periodontal Response During Orthodontic Treatment: a 6-month Randomized Placebo Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Taubate · Academic / Other
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Essential oils	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.
DRUG	Cetylpyridinium Chloride 0.7 mg/ml	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.
DRUG	Placebos	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.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-03-10
• Completion: 2018-07-10
• First posted: 2017-06-07
• Last updated: 2017-06-07

Locations

1 site across 1 country: Brazil