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Trial record 9 of 11 for:    thymol

Mouthwashes During Orthodontic Treatment (MOUORT)

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ClinicalTrials.gov Identifier: NCT03179735
Recruitment Status : Unknown
Verified June 2017 by University of Taubate.
Recruitment status was:  Enrolling by invitation
First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of Taubate

Tracking Information
First Submitted Date  ICMJE June 1, 2017
First Posted Date  ICMJE June 7, 2017
Last Update Posted Date June 7, 2017
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date March 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
Changes in gingival index [ Time Frame: up to 6 months ]
Gingival index changes (mean scores) from baseline to 6 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • Changes in plaque index [ Time Frame: up to 6 months ]
    Plaque index changes (mean scores) from baseline to 6 months.
  • Changes in subgingival bacterial levels [ Time Frame: up to 6 months ]
    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 [ Time Frame: up to 6 months ]
    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 [ Time Frame: up to 6 months ]
    Gingival overgrowth changes (mean scores) from baseline to 6 months.
  • Corrosion of orthodontic devices [ Time Frame: up to 6 months ]
    Percentage of areas of orthodontic devices showing corrosive superficial changes at 3 and 6 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mouthwashes During Orthodontic Treatment
Official Title  ICMJE Mouthwashes as Positive Modulators of Periodontal Response During Orthodontic Treatment: a 6-month Randomized Placebo Controlled Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Gingivitis
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Experimental: Essential oils mouthwash
    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%)
    Intervention: Drug: Essential oils
  • Experimental: Cetylpyridinium mouthwash
    Cetylpyridinium chloride group will rinse with an alcohol-free mouthwash (twice daily use; 20 ml/30 s) containing cetylpyridinium chloride 0.7 mg/ml
    Intervention: Drug: Cetylpyridinium Chloride 0.7 mg/ml
  • Placebo Comparator: Placebos mouthwash
    Placebo group will rinse with an alcohol-free placebo solution (twice daily use; 20 ml/30 s)
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 10, 2018
Estimated Primary Completion Date March 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03179735
Other Study ID Numbers  ICMJE MOUORT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual participant data will be shared.
Responsible Party University of Taubate
Study Sponsor  ICMJE University of Taubate
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sheila C Cortelli, PhD Dean periodontics department
PRS Account University of Taubate
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP