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. - Full Text View

Purpose

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.

Condition	Intervention
Gingivitis Dental Plaque Accumulation	Drug: Essential oils mouthrinse Drug: Delmopinol mouthrinse

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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.

Resource links provided by NLM:

Drug Information available for: Listerine Lactobacillus

U.S. FDA Resources

Further study details as provided by University of Lisbon:

Primary Outcome Measures:

Loe & Silness Gingival Index (1963) [ Time Frame: change from baseline in gingival index at two weeks ] [ Designated as safety issue: No ]
data collected at the begining of the study and two weeks after mouthrinse usage.
Quigley, Hein & Turesky Dental Plaque Index (1970) [ Time Frame: change from baseline in plaque index at two weeks ] [ Designated as safety issue: No ]
data collected at the begining of the study and two weeks after mouthrinse usage.

Secondary Outcome Measures:

Streptococcus mutans CFU [ Time Frame: change from baseline in CFU counts at two weeks ] [ Designated as safety issue: No ]
data collected at the begining of the study and two weeks after mouthrinse usage.
Lactobacillus CFU [ Time Frame: change from baseline in CFU counts at two weeks ] [ Designated as safety issue: No ]
data collected at the begining of the study and two weeks after mouthrinse usage.
Aerobic and anaerobic oral bacteria CFU [ Time Frame: change from baseline in CFU counts at two weeks ] [ Designated as safety issue: No ]
data collected at the begining of the study and two weeks after mouthrinse usage.

Enrollment:	90
Study Start Date:	April 2007
Study Completion Date:	September 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Delmopinol mouthrinse Subjects use the delmopinol mouthrinse	Drug: Delmopinol mouthrinse Commercial mouthrinse with manufacturer's use indication Other Name: Decapinol
No Intervention: Control Subjects with no use of mouthrinse
Experimental: Essential oils mouthrinse Subjects using the essential oils mouthrinse	Drug: Essential oils mouthrinse Commercial mouthrinse with manufacturer's use indication Other Name: Listerine Cool Mint

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236950

Locations

Portugal
Faculdade de Medicina Dentária da Universidade de Lisboa
Lisboa, Portugal, 1649-003

Sponsors and Collaborators

University of Lisbon

Instituto Piaget

Investigators

Study Director:

Mario F Bernardo, PhD

Faculdade de Medicina Dentária da Universidade de Lisboa

More Information

Publications:

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.

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.

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

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.

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.

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.

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

Responsible Party:	Henrique Soares Luis, Faculdade de Medicina Dentária da Universidade de Lisboa
ClinicalTrials.gov Identifier:	NCT01236950 History of Changes
Other Study ID Numbers:	9/2006a
Study First Received:	November 8, 2010
Last Updated:	November 9, 2010
Health Authority:	Portugal: Health Ethic Committee

Keywords provided by University of Lisbon:

Clinical Trial
Prevention Mouthrinse

Additional relevant MeSH terms:

Dental Plaque
Gingivitis
Dental Deposits
Tooth Diseases

Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Mouth Diseases

ClinicalTrials.gov processed this record on May 16, 2013