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CompletedNCT01236950Updated Nov 10, 2010

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.

An interventional study of Essential oils mouthrinse and Delmopinol mouthrinse in Gingivitis and Dental Plaque Accumulation, sponsored by University of Lisbon. Completed at 1 site in Portugal. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-10.

Sponsored by University of Lisbon · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gingivitis
  • Dental Plaque Accumulation

Keywords

  • Clinical Trial
  • Prevention Mouthrinse
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In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 90 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

University of Lisbon is the lead sponsor of 38 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Delmopinol mouthrinse

    Subjects use the delmopinol mouthrinse

    Drug: Delmopinol mouthrinse

  • No intervention
    Control

    Subjects with no use of mouthrinse

  • Experimental
    Essential oils mouthrinse

    Subjects using the essential oils mouthrinse

    Drug: Essential oils mouthrinse

Interventions

  • DrugEssential oils mouthrinse

    Commercial mouthrinse with manufacturer's use indication

    Also known as: Listerine Cool Mint

  • DrugDelmopinol mouthrinse

    Commercial mouthrinse with manufacturer's use indication

    Also known as: Decapinol

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What researchers measure

Primary outcomes

  1. Loe & Silness Gingival Index (1963)

    data collected at the begining of the study and two weeks after mouthrinse usage.

    Time frame: change from baseline in gingival index at two weeks

  2. Quigley, Hein & Turesky Dental Plaque Index (1970)

    data collected at the begining of the study and two weeks after mouthrinse usage.

    Time frame: change from baseline in plaque index at two weeks

Secondary outcomes

  1. Streptococcus mutans CFU

    data collected at the begining of the study and two weeks after mouthrinse usage.

    Time frame: change from baseline in CFU counts at two weeks

  2. Lactobacillus CFU

    data collected at the begining of the study and two weeks after mouthrinse usage.

    Time frame: change from baseline in CFU counts at two weeks

  3. Aerobic and anaerobic oral bacteria CFU

    data collected at the begining of the study and two weeks after mouthrinse usage.

    Time frame: change from baseline in CFU counts at two weeks

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Study locations

1 site
  • Faculdade de Medicina Dentária da Universidade de Lisboa
    Lisboa, 1649-003, Portugal
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References and documents

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. doi: 10.1902/jop.1994.65.5.437. PubMed 8046559 ↗
  • 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. PubMed 17116159 ↗
  • 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. PubMed 12974527 ↗
  • 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. Erratum In: J Am Dent Assoc. 2008 Mar;139(3):252. PubMed 17035671 ↗
  • 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. PubMed 10743861 ↗
  • 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. PubMed 3902908 ↗
  • 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. PubMed 12787196 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01236950
Lead sponsor
University of Lisbon
Collaborators
Instituto Piaget
First posted
Nov 9, 2010
Start date
Apr 2007
Primary completion
Apr 2008
Completion
Sep 2008
Last update
Nov 10, 2010

Study contacts

Mario F Bernardo, PhD
study director · Faculdade de Medicina Dentária da Universidade de Lisboa

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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