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.

NCT ID: NCT01236950

Last Updated: 2010-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-09-30

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.

Detailed Description

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Conditions

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Gingivitis Dental Plaque Accumulation

Keywords

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Clinical Trial Prevention Mouthrinse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Delmopinol mouthrinse

Subjects use the delmopinol mouthrinse

Group Type EXPERIMENTAL

Delmopinol mouthrinse

Intervention Type DRUG

Commercial mouthrinse with manufacturer's use indication

Control

Subjects with no use of mouthrinse

Group Type NO_INTERVENTION

No interventions assigned to this group

Essential oils mouthrinse

Subjects using the essential oils mouthrinse

Group Type EXPERIMENTAL

Essential oils mouthrinse

Intervention Type DRUG

Commercial mouthrinse with manufacturer's use indication

Interventions

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Essential oils mouthrinse

Commercial mouthrinse with manufacturer's use indication

Intervention Type DRUG

Delmopinol mouthrinse

Commercial mouthrinse with manufacturer's use indication

Intervention Type DRUG

Other Intervention Names

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Listerine Cool Mint Decapinol

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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Piaget

OTHER

Sponsor Role collaborator

University of Lisbon

OTHER

Sponsor Role lead

Responsible Party

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Faculdade de Medicina Dentária da Universidade de Lisboa

Principal Investigators

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Mario F Bernardo, PhD

Role: STUDY_DIRECTOR

Faculdade de Medicina Dentária da Universidade de Lisboa

Locations

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Faculdade de Medicina Dentária da Universidade de Lisboa

Lisbon, Lisbon District, Portugal

Site Status

Countries

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Portugal

References

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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. doi: 10.1902/jop.1994.65.5.437.

Reference Type BACKGROUND
PMID: 8046559 (View on PubMed)

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. doi: 10.1111/j.1600-051X.2006.01013.x. Epub 2006 Nov 20.

Reference Type BACKGROUND
PMID: 17116159 (View on PubMed)

Baehni PC, Takeuchi Y. Anti-plaque agents in the prevention of biofilm-associated oral diseases. Oral Dis. 2003;9 Suppl 1:23-9. doi: 10.1034/j.1601-0825.9.s1.5.x.

Reference Type BACKGROUND
PMID: 12974527 (View on PubMed)

Barnett ML. The rationale for the daily use of an antimicrobial mouthrinse. J Am Dent Assoc. 2006 Nov;137 Suppl:16S-21S. doi: 10.14219/jada.archive.2006.0408.

Reference Type BACKGROUND
PMID: 17035671 (View on PubMed)

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. doi: 10.1034/j.1600-051x.2000.027003157.x.

Reference Type BACKGROUND
PMID: 10743861 (View on PubMed)

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. doi: 10.1111/j.1600-051x.1985.tb00941.x.

Reference Type BACKGROUND
PMID: 3902908 (View on PubMed)

Ouhayoun JP. Penetrating the plaque biofilm: impact of essential oil mouthwash. J Clin Periodontol. 2003;30 Suppl 5:10-2. doi: 10.1034/j.1600-051x.30.s5.4.x.

Reference Type BACKGROUND
PMID: 12787196 (View on PubMed)

Other Identifiers

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9/2006a

Identifier Type: -

Identifier Source: org_study_id