Essential Oils Mouth Rinse and Dental Floss: Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation

NCT ID: NCT01236963

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-09-30

Brief Summary

It is difficult to obtain patient's compliance with regular interproximal dental hygiene. Dental floss is recognized as an effective procedure to remove dental plaque and prevent gingivitis in the space between teeth, but it is difficult to use and most patients do no do it regularly. Essential oils mouthrinse acts on dental plaque bacteria and helps on gingivitis prevention. These properties may be of interest to control dental plaque accumulation and gingivitis in interproximal areas. The study hypothesis states that there are no differences between the use of an essential oils mouthrinse and dental floss on the reduction of dental plaque accumulation and gingivitis.

Detailed Description

The use of mouthwashes or rinses as an adjunct to mechanical plaque removal should be considered by oral health professionals as part of a strategy to prevent and control patients' oral problems. Most individuals do not brush or floss for the required duration or with the necessary skill to ensure effectiveness, even after receiving hygiene instruction and motivation (Beals et al., 2000; Ciancio, 2003; Santos, 2003). Consequently, inadequate oral hygiene leads to plaque buildup, a key etiological factor in periodontal disease and dental caries. Mouthwashes containing essential oils and rinses with delmopinol have proven effective in controlling plaque development and preventing gingivitis (Baehni and Takeuchi, 2003).

The American Dental Association (ADA) has established guidelines for studying the efficacy of oral hygiene products on gingivitis and plaque accumulation. These guidelines, found in the Acceptance Program Guidelines, provide instructions on planning and evaluating various types of laboratory and clinical studies to test mouthwashes and rinses (ADA, 1997-2008).

In laboratory studies, the effectiveness of antiseptic oral products is tested for their ability to inhibit oral microorganisms. The goal is to determine if these products alter the oral flora. Plaque samples for these studies are collected at baseline and at the end of the experimental period from a predetermined dental surface. Samples are recorded in colony-forming units per millilitre (CFU/ml). For non-specific plaque evaluation, samples are grown on a general nutrient medium, while specific bacteria require selective culture media (ADA, 2008). Bacterial resistance and growth inhibition are assessed using the minimum inhibitory concentration method, typically via the disk diffusion test (ADA, 2008).

Clinical studies, approved by an ethics committee, must demonstrate the efficacy of mouthwashes and rinses in reducing plaque accumulation and gingivitis. Participants undergo a comprehensive oral examination at the study's outset to assess initial conditions, inclusion, and exclusion criteria, and to obtain informed consent (ADA, 1997). Clinical variables are measured at baseline, at study end, and optionally at an intermediate point (ADA, 2006). Sample size must allow for statistical testing with a significance level of 1% or 5% and a power of 80% whenever possible (ADA, 2007). Study duration varies by objective; demonstrating antiseptic properties requires at least six months, while evaluating effects on gingivitis and plaque can be done in as little as two weeks (Collaert et al., 1992-2007).

Participants should be from the product's target population, with usage not necessarily supervised by the researcher. Studies must include both genders and various age groups, with random assignment to experimental and control groups (ADA, 2008). Participants must be healthy adults with no oral pathology and similar oral hygiene conditions, avoiding medications that affect gingival parameters during the study (ADA, 2008). Clinical variables related to plaque and gingivitis are assessed using scientifically recognized indices.

In summary, this study aims to evaluate the effectiveness of mouthwashes and rinses in controlling plaque and gingivitis, following established guidelines to ensure rigorous and systematic assessment.

Conditions

Gingivitis; Dental Plaque Accumulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Essential oils mouthrinse

Subjects use the essential oils mouthrinse

Group Type: EXPERIMENTAL

Essential oils mouthrinse

Intervention Type: DRUG

Commercial mouthrinse with manufacturer's use indications

Dental floss

Subjects use dental floss

Group Type: ACTIVE_COMPARATOR

Dental Floss

Intervention Type: DEVICE

Interventions

Essential oils mouthrinse

Commercial mouthrinse with manufacturer's use indications

Intervention Type: DRUG

Dental Floss

Intervention Type: DEVICE

Other Intervention Names

Listerine Cool Mint; Colgate Total dental floss

Eligibility Criteria

Inclusion Criteria

• To be a student at the Dental Hygiene programme at the Lisbon Dental School
• Signature on informed consent form
• Have, at least, two quadrant with 6 teeth each
• Presence of dental plaque

Exclusion Criteria

• Use of a mouthrinse
• Dental hygiene appointment in the past 6 months
• Use of antibiotics in the past 3 months
• Presence of extensive caries and fractures of teeth

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Piaget

OTHER

Sponsor Role: collaborator

University of Lisbon

OTHER

Sponsor Role: lead

Responsible Party

Henrique Soares Luis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mario F Bernardo, PhD

Role: STUDY_DIRECTOR

Faculdade de Medicina Dentária da Universidade de Lisboa

Locations

Faculdade de Medicina Dentária da Universidade de Lisboa

Lisbon, , Portugal

Countries

Portugal

References

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.

Reference Type: BACKGROUND

PMID: 17035671 (View on PubMed)

Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.

Reference Type: BACKGROUND

PMID: 12699051 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3902908 (View on PubMed)

Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. doi: 10.14219/jada.archive.2004.0217.

Reference Type: BACKGROUND

PMID: 15127875 (View on PubMed)

Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.

Reference Type: BACKGROUND

PMID: 12691269 (View on PubMed)

Other Identifiers

9/2006b

Identifier Type: -

Identifier Source: org_study_id