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.

Not Applicable

Completed

• Conditions: Gingivitis; Dental Plaque Accumulation
• Interventions: Drug: Delmopinol mouthrinse; Drug: Essential oils mouthrinse

• Registration Number: NCT01236950
• Lead Sponsor: University of Lisbon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2008-04
• Study Completion: 2008-09
• Status Verified: 2010-07
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Last Update Submitted: 2010-11-09
• Last Update Posted: 2010-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delmopinol mouthrinse	Delmopinol mouthrinse	Subjects use the delmopinol mouthrinse
Essential oils mouthrinse	Essential oils mouthrinse	Subjects using the essential oils mouthrinse

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Streptococcus mutans CFU	change from baseline in CFU counts at two weeks	data collected at the begining of the study and two weeks after mouthrinse usage.
Lactobacillus CFU	change from baseline in CFU counts at two weeks	data collected at the begining of the study and two weeks after mouthrinse usage.
Aerobic and anaerobic oral bacteria CFU	change from baseline in CFU counts at two weeks	data collected at the begining of the study and two weeks after mouthrinse usage.

Trial Locations

Locations (1)

Faculdade de Medicina Dentária da Universidade de Lisboa; 🇵🇹 Lisboa, Portugal