Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 13 for:    eucalyptol

Mouthwashes During Orthodontic Treatment (MOUORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
Gingivitis Drug: Essential oils Drug: Cetylpyridinium Chloride 0.7 mg/ml Drug: Placebos Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mouthwashes as Positive Modulators of Periodontal Response During Orthodontic Treatment: a 6-month Randomized Placebo Controlled Clinical Trial
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 10, 2018
Estimated Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
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%)
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.


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
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.


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





Primary Outcome Measures :
  1. Changes in gingival index [ Time Frame: up to 6 months ]
    Gingival index changes (mean scores) from baseline to 6 months.


Secondary Outcome Measures :
  1. Changes in plaque index [ Time Frame: up to 6 months ]
    Plaque index changes (mean scores) from baseline to 6 months.

  2. 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.

  3. 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.

  4. Changes in gingival overgrowth measurements [ Time Frame: up to 6 months ]
    Gingival overgrowth changes (mean scores) from baseline to 6 months.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179735


Locations
Layout table for location information
Brazil
Nucleus of periodontal research of University of Taubate
Taubate, SP, Brazil, 12020330
Sponsors and Collaborators
University of Taubate
Investigators
Layout table for investigator information
Principal Investigator: Sheila C Cortelli, PhD Dean periodontics department

Layout table for additonal information
Responsible Party: University of Taubate
ClinicalTrials.gov Identifier: NCT03179735     History of Changes
Other Study ID Numbers: MOUORT
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Cetylpyridinium
Anti-Infective Agents, Local
Anti-Infective Agents