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Mouthwashes During Orthodontic Treatment (MOUORT)

Primary Purpose

Gingivitis

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Essential oils
Cetylpyridinium Chloride 0.7 mg/ml
Placebos
Sponsored by
University of Taubate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Sites / Locations

  • Nucleus of periodontal research of University of Taubate

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Essential oils mouthwash

Cetylpyridinium mouthwash

Placebos mouthwash

Arm Description

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%)

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in plaque index
Plaque index changes (mean scores) from baseline to 6 months.
Changes in subgingival bacterial levels
Changes in bacterial levels (total number of bacterial cells and specific numbers of Actinomyces naeslundii, Streptococcus oralis, Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola) from sub gingival samples.
Changes in bracket bacterial levels
Changes in bacterial levels (total number of bacterial cells and specific numbers of Actinomyces naeslundii, Streptococcus oralis, Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola) from bracket samples.
Changes in gingival overgrowth measurements
Gingival overgrowth changes (mean scores) from baseline to 6 months.
Corrosion of orthodontic devices
Percentage of areas of orthodontic devices showing corrosive superficial changes at 3 and 6 months.

Full Information

First Posted
June 1, 2017
Last Updated
June 5, 2017
Sponsor
University of Taubate
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1. Study Identification

Unique Protocol Identification Number
NCT03179735
Brief Title
Mouthwashes During Orthodontic Treatment
Acronym
MOUORT
Official Title
Mouthwashes as Positive Modulators of Periodontal Response During Orthodontic Treatment: a 6-month Randomized Placebo Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 10, 2018 (Anticipated)
Study Completion Date
July 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Taubate

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Essential oils mouthwash
Arm Type
Experimental
Arm Description
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%)
Arm Title
Cetylpyridinium mouthwash
Arm Type
Experimental
Arm Description
Cetylpyridinium chloride group will rinse with an alcohol-free mouthwash (twice daily use; 20 ml/30 s) containing cetylpyridinium chloride 0.7 mg/ml
Arm Title
Placebos mouthwash
Arm Type
Placebo Comparator
Arm Description
Placebo group will rinse with an alcohol-free placebo solution (twice daily use; 20 ml/30 s)
Intervention Type
Drug
Intervention Name(s)
Essential oils
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetylpyridinium Chloride 0.7 mg/ml
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in gingival index
Description
Gingival index changes (mean scores) from baseline to 6 months.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Changes in plaque index
Description
Plaque index changes (mean scores) from baseline to 6 months.
Time Frame
up to 6 months
Title
Changes in subgingival bacterial levels
Description
Changes in bacterial levels (total number of bacterial cells and specific numbers of Actinomyces naeslundii, Streptococcus oralis, Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola) from sub gingival samples.
Time Frame
up to 6 months
Title
Changes in bracket bacterial levels
Description
Changes in bacterial levels (total number of bacterial cells and specific numbers of Actinomyces naeslundii, Streptococcus oralis, Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola) from bracket samples.
Time Frame
up to 6 months
Title
Changes in gingival overgrowth measurements
Description
Gingival overgrowth changes (mean scores) from baseline to 6 months.
Time Frame
up to 6 months
Title
Corrosion of orthodontic devices
Description
Percentage of areas of orthodontic devices showing corrosive superficial changes at 3 and 6 months.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila C Cortelli, PhD
Organizational Affiliation
Dean periodontics department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nucleus of periodontal research of University of Taubate
City
Taubate
State/Province
SP
ZIP/Postal Code
12020330
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared.

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Mouthwashes During Orthodontic Treatment

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