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.

NCT01236950 | Completed

• 1 other identifier: 9/2006a
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Dental Plaque Accumulation

Keywords

Clinical Trial; Prevention Mouthrinse

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Streptococcus mutans CFU

  change from baseline in CFU counts at two weeks

• Lactobacillus CFU

  change from baseline in CFU counts at two weeks

• Aerobic and anaerobic oral bacteria CFU

  change from baseline in CFU counts at two weeks

Study Arms (3)

Delmopinol mouthrinse

EXPERIMENTAL

Subjects use the delmopinol mouthrinse

Drug: Delmopinol mouthrinse

Control

NO INTERVENTION

Subjects with no use of mouthrinse

Essential oils mouthrinse

EXPERIMENTAL

Subjects using the essential oils mouthrinse

Drug: Essential oils mouthrinse

Interventions

Essential oils mouthrinse DRUG

Commercial mouthrinse with manufacturer's use indication

Also known as: Listerine Cool Mint

Essential oils mouthrinse

Delmopinol mouthrinse DRUG

Commercial mouthrinse with manufacturer's use indication

Also known as: Decapinol

Delmopinol mouthrinse

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lisbon: lead
• Instituto Piaget: collaborator

Study Sites (1)

Faculdade de Medicina Dentária da Universidade de Lisboa

Lisbon, Lisbon District, 1649-003, Portugal

Location

Related 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. doi: 10.1902/jop.1994.65.5.437.

  PMID: 8046559 BACKGROUND

• 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.

  PMID: 17116159 BACKGROUND

• 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.

  PMID: 12974527 BACKGROUND

• 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.

  PMID: 17035671 BACKGROUND

• 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.

  PMID: 10743861 BACKGROUND

• 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.

  PMID: 3902908 BACKGROUND

• 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.

  PMID: 12787196 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Interventions

delmopinol

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mario F Bernardo, PhD

  Faculdade de Medicina Dentária da Universidade de Lisboa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: April 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 10, 2010

Record last verified: 2010-07

Locations

PT (1)