Clinical trial 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.
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 Anaerobic Oral Bacteria Colony Counts.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Dental Plaque Accumulation
Keywords: Clinical Trial
Prevention Mouthrinse
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: Instituto Piaget
First posted: 2010-11-09
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Loe & Silness Gingival Index (1963)
timeFrame: change from baseline in gingival index at two weeks
measure: Quigley, Hein & Turesky Dental Plaque Index (1970)
timeFrame: change from baseline in plaque index at two weeks
Secondary outcomes:
measure: Streptococcus mutans CFU
timeFrame: change from baseline in CFU counts at two weeks
measure: Lactobacillus CFU
timeFrame: change from baseline in CFU counts at two weeks
measure: Aerobic and anaerobic oral bacteria CFU
timeFrame: change from baseline in CFU counts at two weeks
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Faculdade de Medicina Dentária da Universidade de Lisboa
Study officials:
affiliation: Faculdade de Medicina Dentária da Universidade de Lisboa
name: Mario F Bernardo, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.