Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.

Study Overview
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Brief Summary
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The use of mouthrinses may be of relevance as a complement to daily dental hygiene procedures, especially for patients who do not comply with a proper mechanical removal of dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental plaque accumulation and gingivitis. Also an effect on dental bacteria can be found. The study hypothesis states that there are no differences between the mouthrinses on the reduction of gingivitis and dental plaque accumulation as well on the bacterial counts of Streptococcus mutans, Lactobacillus, aerobic and anaerobic bacteria.

Official Title
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Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.

Conditions
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Gingivitis, Dental Plaque Accumulation

Intervention / Treatment
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* Drug: Essential oils mouthrinse
* Drug: Delmopinol mouthrinse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at the dental hygiene clinic of Faculdade de Medicina Dentária Signature of consent form Have, at least, two quadrant with 6 teeth each Gingival Index at baseline less than 3 Presence of dental plaque Exclusion Criteria: Use of a mouthrinse Dental Hygiene appointment in the past 6 months Use of antibiotics in teh past 3 months Presence of extensive caries and fractures of teeth

Ages Eligible for Study
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Minimum Age: 15 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delmopinol mouthrinse<br>Subjects use the delmopinol mouthrinse | Drug: Delmopinol mouthrinse<br>* Commercial mouthrinse with manufacturer's use indication<br>* Other names: Decapinol;|
| No Intervention: Control<br>Subjects with no use of mouthrinse | |
| Experimental: Essential oils mouthrinse<br>Subjects using the essential oils mouthrinse | Drug: Essential oils mouthrinse<br>* Commercial mouthrinse with manufacturer's use indication<br>* Other names: Listerine Cool Mint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loe & Silness Gingival Index (1963) | data collected at the begining of the study and two weeks after mouthrinse usage. | change from baseline in gingival index at two weeks | 
| Quigley, Hein & Turesky Dental Plaque Index (1970) | data collected at the begining of the study and two weeks after mouthrinse usage. | change from baseline in plaque index at two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Streptococcus mutans CFU | data collected at the begining of the study and two weeks after mouthrinse usage. | change from baseline in CFU counts at two weeks | 
| Lactobacillus CFU | data collected at the begining of the study and two weeks after mouthrinse usage. | change from baseline in CFU counts at two weeks | 
| Aerobic and anaerobic oral bacteria CFU | data collected at the begining of the study and two weeks after mouthrinse usage. | change from baseline in CFU counts at two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Trial, Prevention Mouthrinse