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

NCT07005011 | Not Yet Recruiting

• 1 other identifier: 2024_RIPH_30_Hydro-Paro
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Gingivitis; oral irrigator; interdental brushes; interdental hygiene

Outcome Measures

Primary Outcomes (1)

• Approximal plaque index (API - Lange, 1977)

  API is the number of interdental spaces covered by plaque divided by the total number of interdental spaces studied, expressed as a percentage. To calculate it, the interdental spaces are visually examined by the dental surgeon to determine whether or not the surface is covered by plaque.

  12 weeks

Secondary Outcomes (3)

• Plaque control record (PCR - O'Lheary et al., 1972)

  12 weeks

• Bleeding on probing (BOP - Ainamo et Bay, 1975)

  12 weeks

• General Oral Health Assessment Index (GOHAI - Tubert-Jeanin et al., 2003)

  12 weeks

Study Arms (2)

group 1: "oral irrigator" group

EXPERIMENTAL

group 1: patients using oral irrigator as interdental hygiene tools

Other: oral irrigator

group2: "calibrated interdental brushes" group

ACTIVE COMPARATOR

group 2: patients using calibrated interdental brushes as interdental hygiene tools

Other: oral irrigator

Interventions

oral irrigator OTHER

oral irrigator

group 1: "oral irrigator" group; group2: "calibrated interdental brushes" group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with gingivitis (according to the International Classification of Periodontal Diseases; Chapple et al., 2018 i.e. a BOP greater than 10%).
• with at least 10 pairs of antagonistic teeth
• able to carry out oral hygiene procedures independently
• able to understand the instructions for using interdental devices
• fluent in French
• adults
• affiliated to a social security scheme
• agreeing to take part in the study

You may not qualify if:

• daily use of one of the study devices (hydropulper, whatever the model, or calibrated interdental brushes)
• with eating disorders
• with ongoing orthodontic treatment
• protected by law (guardianship, curatorship, safeguard of justice)
• pregnant or breast-feeding women
• refusing to take part in the study

Sponsors & Collaborators

• Université de Reims Champagne-Ardenne: lead

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Barbe Coralie, DR

CONTACT

03 26 91 36 65; coralie.barbe1@univ-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05