Effect of Different Mouthrinses in Plaque Formation
Anti-plaque Effect of 0.12% Chlorhexidine Gluconate Rinsing and Nanoparticle Solution of 0.3% Melaleuca Alternifolia: A Randomized Crossover Clinical Trial
2 other identifiers
interventional
59
0 countries
N/A
Brief Summary
Although several studies have assessed the efficacy of chlorhexidine in treating gingivitis and reducing biofilm formation, the side effects of a long-term use are unpleasant for patients. Melaleuca alternifolia oil has been considered as an alternative because of its anti-inflammatory properties. However, little is know about the efficacy of its nanoparticles. The purpose of this study is to compare the effect of 0.12% chlorhexidine (Periogard ®) and a nanoparticle solution of 0.3% M. alternifolia oil in reducing biofilm formation in plaque-free and plaque-covered teeth surfaces.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2016
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2016
CompletedFirst Posted
Study publicly available on registry
March 1, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 1, 2016
February 1, 2016
9 months
February 21, 2016
February 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dental plaque/biofilm formation.
7 days.
Secondary Outcomes (1)
Gingival abrasion.
7 days.
Other Outcomes (2)
Gingival crevicular fluid- measured through an electronic gingival fluid measuring device (Periotron®)
7 days.
Perception of appreciation- questionnaire
7 days.
Study Arms (2)
Chlorhexidine gluconate (0,12%)
EXPERIMENTALSubjects will rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%).
M. alternifolia oil (Nanoparticle solution)
EXPERIMENTALSubjects will rinse twice daily with 15 ml mouthrinse containing nanoparticles of M. alternifolia oil (0.3%).
Interventions
At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%). Plaque indices will be recorded at baseline, day 4, and day 7.
At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing a nanoparticle solution of M. alternifolia oil (0.3%). Plaque indices will be recorded at baseline, day 4, and day 7.
Eligibility Criteria
You may qualify if:
- Individuals must be systemically healthy;
- Must have at least six teeth per quadrant;
- Must not be undergoing medical treatment;
You may not qualify if:
- Allergies or hypersensitivity to the components (Chlorhexidine Gluconate or M. alternifolia oil nanoparticles);
- Antibiotic therapy within 3 months prior to baseline examination;
- History of periodontal disease;
- Marginal bleeding index higher than 15%;
- Oral mucosal lesions;
- Pregnancy or breastfeeding;
- Presence of active infectious foci (endodontic abscesses);
- Presence of plaque retentive factors (caries, aesthetic or ill-fitting restorations, orthodontic appliances, fixed or removable prosthesis);
- Smokers;
- Systemic conditions (diabetes, immunosuppression);
- Use of any mouthwash within 21 days prior to baseline examination;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Rahman B, Alkawas S, Al Zubaidi EA, Adel OI, Hawas N. Comparative antiplaque and antigingivitis effectiveness of tea tree oil mouthwash and a cetylpyridinium chloride mouthwash: A randomized controlled crossover study. Contemp Clin Dent. 2014 Oct;5(4):466-70. doi: 10.4103/0976-237X.142813.
PMID: 25395761BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fabricio B. Zanatta, PhD
Adjunct Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MsC, Federal University of Santa Maria
Study Record Dates
First Submitted
February 21, 2016
First Posted
March 1, 2016
Study Start
March 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 1, 2016
Record last verified: 2016-02