Clinical Trial: 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.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Lisbon

Current Primary Outcome:

• 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.
• 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.

Original Primary Outcome:

• Loe & Silness Gingival Index (1963) [ Time Frame: before and two weeks after intervention ]
  data collected at the begining of the study and two weeks after mouthrinse usage.
• Quigley, Hein & Turesky Dental Plaque Index (1970) [ Time Frame: before and two weeks after intervention ]
  data collected at the begining of the study and two weeks after mouthrinse usage.

Current Secondary Outcome:

• 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.
• 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.
• 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.

Original Secondary Outcome:

• Streptococcus mutans CFU [ Time Frame: before and two weeks after intervention ]
  data collected at the begining of the study and two weeks after mouthrinse usage.
• Lactobacillus CFU [ Time Frame: before and two weeks after intervention ]
  data collected at the begining of the study and two weeks after mouthrinse usage.
• Aerobic and anaerobic oral bacteria CFU [ Time Frame: before and two weeks after intervention ]
  data collected at the begining of the study and two weeks after mouthrinse usage.

Information By: University of Lisbon

Dates:
Date Received: November 8, 2010
Date Started: April 2007
Date Completion:
Last Updated: November 9, 2010
Last Verified: July 2010