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.

Gingivitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236950
• Other study ID #: 9/2006a
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: November 9, 2010
• Start date: April 2007
• Est. completion date: September 2008

Study information

• Verified date: July 2010
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Plaque
• Dental Plaque Accumulation
• Gingivitis

Intervention

Drug:
• Essential oils mouthrinse
Commercial mouthrinse with manufacturer's use indication
• Delmopinol mouthrinse
Commercial mouthrinse with manufacturer's use indication

Locations

Country	Name	City	State
Portugal	Faculdade de Medicina Dentária da Universidade de Lisboa	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
University of Lisbon	Instituto Piaget

Country where clinical trial is conducted

Portugal, 

References & Publications (7)

Abbott DM, Gunsolley JC, Koertge TE, Payne EL. The relative efficacy of 0.1% and 0.2% delmopinol mouthrinses in inhibiting the development of supragingival dental plaque and gingivitis in man. J Periodontol. 1994 May;65(5):437-41. — View Citation

Addy M, Moran J, Newcombe RG. Meta-analyses of studies of 0.2% delmopinol mouth rinse as an adjunct to gingival health and plaque control measures. J Clin Periodontol. 2007 Jan;34(1):58-65. Epub 2006 Nov 20. — View Citation

Baehni PC, Takeuchi Y. Anti-plaque agents in the prevention of biofilm-associated oral diseases. Oral Dis. 2003;9 Suppl 1:23-9. Review. — View Citation

Barnett ML. The rationale for the daily use of an antimicrobial mouthrinse. J Am Dent Assoc. 2006 Nov;137 Suppl:16S-21S. Review. Erratum in: J Am Dent Assoc. 2008 Mar;139(3):252. — View Citation

Fine DH, Furgang D, Barnett ML, Drew C, Steinberg L, Charles CH, Vincent JW. Effect of an essential oil-containing antiseptic mouthrinse on plaque and salivary Streptococcus mutans levels. J Clin Periodontol. 2000 Mar;27(3):157-61. — View Citation

Gordon JM, Lamster IB, Seiger MC. Efficacy of Listerine antiseptic in inhibiting the development of plaque and gingivitis. J Clin Periodontol. 1985 Sep;12(8):697-704. — View Citation

Ouhayoun JP. Penetrating the plaque biofilm: impact of essential oil mouthwash. J Clin Periodontol. 2003;30 Suppl 5:10-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No