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Comparison of the Efficacy of Oral Irrigator Versus Interdental Brushes in the Oral Hygiene of Patients With Gingivitis: a Randomised Study

NCT07005011 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2025-06-04

No results posted yet for this study

Summary

Periodontal health is a public health issue because of the frequency of periodontal disease (more than 50% of the French population suffers from severe periodontitis (Bourgeois, Bouchard and Mattout 2007)), its negative impact on patients' quality of life, speech, self-confidence and well-being, and its association with the development of chronic pathologies (diabetes, metabolic syndrome, rheumatoid arthritis, cardiovascular disease).

Gingivitis is a reversible inflammatory disease of the superficial tissues supporting the teeth. If left untreated, this inflammation will become chronic and spread apically to the deep tissues supporting the tooth, evolving into periodontitis with irreversible damage. The aetiopathogenic phenomena that lead to the onset of periodontal disease are complex, but one of the main aetiopathogenic factors is the bacterial biofilm found in the form of dental plaque.

Maintaining correct oral hygiene remains the main means of preventing periodontal disease (Chapple et al. 2018). Plaque control is achieved by the dental surgeon through scaling and resurfacing at intervals appropriate to the patient, but also by the patient themselves. Mechanical removal of plaque by brushing prevents it from accumulating and prevents the onset of these diseases. This control by the patient is essential to the effectiveness of periodontal treatments and the maintenance of periodontal health.

Plaque control by the patient using a toothbrush is not sufficient and must be supplemented by the use of interdental hygiene (Lindhe and Koch 1967). To date, the most effective interdental hygiene tools for reducing gingival inflammation and the plaque index are interdental brushes (Sälzer et al. 2015). However, their effectiveness requires professional calibration to enable adaptation to all sites, which can then reduce patient compliance through the need to use multiple tools.

Oral irrigator were developed in the 1960s and in 2001 the American Academy of Periodontology recognised their value in reducing gingival inflammation. The oral irrigator Sonicare HX8432 Ultra, Philips® was developed recently, combining water and air. Its pulsatile action is considered to be more conservative of gingival soft tissue and qualitatively modifies the composition of dental plaque.

The advantage of this tool is that, unlike interdental brushes, it does not require calibration and is simpler to use.

Conditions

  • Gingivitis

Interventions

OTHER

oral irrigator

oral irrigator

Sponsors & Collaborators

  • Université de Reims Champagne-Ardenne

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-03-01
Completion
2027-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07005011 on ClinicalTrials.gov