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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.

Primary Purpose

Gingivitis, Dental Plaque Accumulation

Status

Completed

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Essential oils mouthrinse

Delmopinol mouthrinse

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring Clinical Trial, Prevention Mouthrinse

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculdade de Medicina Dentária da Universidade de Lisboa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Delmopinol mouthrinse

Control

Essential oils mouthrinse

Arm Description

Subjects use the delmopinol mouthrinse

Subjects with no use of mouthrinse

Subjects using the essential oils mouthrinse

Outcomes

Primary Outcome Measures

Loe & Silness Gingival Index (1963)

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

Quigley, Hein & Turesky Dental Plaque Index (1970)

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

Secondary Outcome Measures

Streptococcus mutans CFU

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

Lactobacillus CFU

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

Aerobic and anaerobic oral bacteria CFU

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

Full Information

NCT ID

NCT01236950

First Posted

November 8, 2010

Last Updated

November 9, 2010

Sponsor

University of Lisbon

Collaborators

Instituto Piaget

1. Study Identification

Unique Protocol Identification Number

NCT01236950

Brief 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.

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Lisbon

Collaborators

Instituto Piaget

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis, Dental Plaque Accumulation

Keywords

Clinical Trial, Prevention Mouthrinse

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Delmopinol mouthrinse

Arm Type

Experimental

Arm Description

Subjects use the delmopinol mouthrinse

Arm Title

Control

Arm Type

No Intervention

Arm Description

Subjects with no use of mouthrinse

Arm Title

Essential oils mouthrinse

Arm Type

Experimental

Arm Description

Subjects using the essential oils mouthrinse

Intervention Type

Drug

Intervention Name(s)

Essential oils mouthrinse

Other Intervention Name(s)

Listerine Cool Mint

Intervention Description

Commercial mouthrinse with manufacturer's use indication

Intervention Type

Drug

Intervention Name(s)

Delmopinol mouthrinse

Other Intervention Name(s)

Decapinol

Intervention Description

Commercial mouthrinse with manufacturer's use indication

Primary Outcome Measure Information:

Title

Loe & Silness Gingival Index (1963)

Description

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

Title

Quigley, Hein & Turesky Dental Plaque Index (1970)

Description

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 Outcome Measure Information:

Title

Streptococcus mutans CFU

Description

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

Title

Lactobacillus CFU

Description

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

Title

Aerobic and anaerobic oral bacteria CFU

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario F Bernardo, PhD

Organizational Affiliation

Faculdade de Medicina Dentária da Universidade de Lisboa

Official's Role

Study Director

Facility Information:

Facility Name

Faculdade de Medicina Dentária da Universidade de Lisboa

City

Lisboa

ZIP/Postal Code

1649-003

Country

Portugal

12. IPD Sharing Statement

Citations:

PubMed Identifier

8046559

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.

Results Reference

background

PubMed Identifier

17116159

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.

Results Reference

background

PubMed Identifier

12974527

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.

Results Reference

background

PubMed Identifier

17035671

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. Erratum In: J Am Dent Assoc. 2008 Mar;139(3):252.

Results Reference

background

PubMed Identifier

10743861

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.

Results Reference

background

PubMed Identifier

3902908

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.

Results Reference

background

PubMed Identifier

12787196

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.

Results Reference

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