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OpenTrials
Completed

NCT Number: NCT01236950

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.

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.

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Key information

Conditions

Gingivitis Dental Plaque Accumulation Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Medicina Dentária da Universidade de Lisboa

Lisbon, Lisbon District, 1649-003, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Essential oils mouthrinse

Drug

Commercial mouthrinse with manufacturer's use indication

Other names: Listerine Cool Mint

Delmopinol mouthrinse

Drug

Commercial mouthrinse with manufacturer's use indication

Other names: Decapinol

Primary outcomes

  1. Loe & Silness Gingival Index (1963)

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

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

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

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

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

Secondary outcomes

  1. Streptococcus mutans CFU

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

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

  2. Lactobacillus CFU

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

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

  3. Aerobic and anaerobic oral bacteria CFU

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

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

Sponsors and collaborators

Lead sponsor

University of Lisbon

Other

Collaborators

  • Instituto Piaget

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 9, 2010
Registry last updated
Nov 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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