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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07005011
Acronym
Hydro-Paro
Enrollment
340
Registered
2025-06-04
Start date
2025-10-01
Completion date
2027-09-01
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis

Keywords

Gingivitis, oral irrigator, interdental brushes, interdental hygiene

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.

Detailed description

The main objective of this study was to evaluate the benefit of using oral irrigator Sonicare HX8432 Ultra, Philips® in patients with gingivitis on the reduction of the interproximal plaque index (API, Lange, 1975) after 12 weeks of use compared to the use of calibrated interdental brushes. The secondary objectives of this study were to assess the benefit of using oral irrigator Sonicare HX8432 Ultra, Philips® in patients with gingivitis compared with using calibrated interdental brushes : * reduction in the plaque control record (PCR) (O'Lheary et al., 1972) after 12 weeks' use * reduction in Bleeding on probing (BOP) index (Ainamo & Bay, 1975) after 12 weeks' use * on improvement in oral health-related quality of life (GOHAI - Geriatric Oral Health Assessment Index) after 12 weeks' use

Interventions

oral irrigator

Sponsors

Université de Reims Champagne-Ardenne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* daily use of one of the study devices (hydropulper, whatever the model, or calibrated interdental brushes) * with a medical history that could compromise the protocol (psychiatric, medical or pharmacological disorders such as the use in the week prior to inclusion of anti-inflammatory drugs, antibiotics or any compound that could alter or modify the inflammatory response) * 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

Design outcomes

Primary

MeasureTime frameDescription
Approximal plaque index (API - Lange, 1977)12 weeksAPI 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.

Secondary

MeasureTime frameDescription
Plaque control record (PCR - O'Lheary et al., 1972)12 weeksthe PCR is the number of plaque-covered tooth surfaces divided by the total number of tooth surfaces studied, expressed as a percentage. To calculate it, the 4 tooth surfaces (vestibular, mesial, distal, lingual) of all the teeth present will be examined by the dental surgeon using a manual periodontal probe and plaque developer to determine whether or not the surface is covered by dental plaque.
Bleeding on probing (BOP - Ainamo et Bay, 1975)12 weeksBOP is the number of bleeding tooth surfaces divided by the total number of tooth surfaces examined, expressed as a percentage. To calculate it, the 4 tooth faces (vestibular, mesial, distal, lingual) of all teeth present will be examined by the dental surgeon using a manual periodontal probe to determine the presence or absence of bleeding.
General Oral Health Assessment Index (GOHAI - Tubert-Jeanin et al., 2003)12 weeksThe GOHAI consists of 12 questions coded from never (5) to always (1), covering the last 3 months. The GOHAI score is calculated by adding up the scores for all the questions to obtain a score ranging from 12 to 60. A score of 57 to 60 reflects good oral health quality of life; a score of 51 to 56 reflects average oral health quality of life; and a score below 50 reflects poor oral health quality of life.

Contacts

Primary ContactBarbe Coralie, DR
coralie.barbe1@univ-reims.fr03 26 91 36 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026