Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software

Study Overview
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Brief Summary
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The objective of this project was to investigate the short-term in situ anti-plaque effect of cymenol, using the Dentius Deep Plaque software

Official Title
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Randomised Clinical Trial on the Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software

Conditions
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Healthy, Dental Plaque

Intervention / Treatment
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* Drug: Placebo Mouthwash
* Drug: Cymenol mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion criteria were as follows: Systemically healthy volunteers Age between 20-45 years Presence of minimum of 24 permanent teeth No evidence of gingivitis or periodontitis (CPITN= 0) No presence of untreated caries at the start of the study. Exclusion criteria were as follows: Smoker or ex-smoker Presence of dentures or orthodontic appliances Antibiotic treatment in the last 3 months or routine use of oral antiseptics

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants rinsed 10 ml of placebo mouthwash for a period of 60 seconds, three times a day with an interval of 7-9 hours in between, for 4 days (period 1) | Drug: Placebo Mouthwash<br>* Application of mouthwashes<br>|
| Experimental: Cymenol (test)<br>Participants applied a 10 ml rinse of 0.1% cymenol mouthwash for a period of 60 seconds, three times a day with a 7-9 hour interval in between, for 4 days (period 1) and 4 days more (period 2) | Drug: Cymenol mouthwash<br>* Application of mouthwashes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the plaque area: baseline vs 4 days | Change in the percentage of the tooth surface with dental plaque:baseline vs 4 days | Baseline, 4 days | 
| Change in the plaque area: baseline vs 8 days | Change in the percentage of the tooth surface with dental plaque: baseline vs 8 days | Baseline, 8 days | 
| Change in the plaque area: 4 days vs 8 days | Change in the percentage of the tooth surface with dental plaque: 4 days vs 8 days | 4 days, 8 days | 
| Change in the growth rate of dental plaque area: baseline vs 4 days | Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 4 days | Baseline, 4 days | 
| Change in the growth rate of dental plaque area: baseline vs 8 days | Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 8 days | Baseline, 8 days | 
| Change in the growth rate of dental plaque area: 4 days vs 8 days | Change in the growth rate of dental plaque area (percentage area/hour): 4 days vs 8 days | 4 days vs 8 days |