GingivitisHydro-ParoNCT07005011
Comparison of the Efficacy of Oral Irrigator Versus Interdental Brushes in the Oral Hygiene of Patients With Gingivitis: a Randomised Study
A study testing oral irrigator in people with Gingivitis, run by Université de Reims Champagne-Ardenne.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- oral irrigator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Efficacy of the Oral Irrigator Versus Interdental Brushes in the Oral Hygiene of Patients With Gingivitis: a Randomised Study
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.
Read more
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.
Read the 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
- Conditions
- Gingivitis
- Being tested
- oral irrigator
- Keywords
- Gingivitis, oral irrigator, interdental brushes, interdental hygiene
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral irrigatorOther
oral irrigator
| Study group | Role | What they receive |
|---|---|---|
| group 1: "oral irrigator" group | Experimental | group 1: patients using oral irrigator as interdental hygiene tools Receives: Other: oral irrigator |
| group2: "calibrated interdental brushes" group | Active comparator | group 2: patients using calibrated interdental brushes as interdental hygiene tools Receives: Other: oral irrigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
Plaque control record (PCR - O'Lheary et al., 1972)
the 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.
Measured: 12 weeks
Bleeding on probing (BOP - Ainamo et Bay, 1975)
BOP 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.
Measured: 12 weeks
General Oral Health Assessment Index (GOHAI - Tubert-Jeanin et al., 2003)
The 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005011
- Sponsor's protocol ID
- 2024_RIPH_30_Hydro-Paro
- Acronym
- Hydro-Paro
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of the Oral Irrigator Versus Interdental Brushes in the Oral Hygiene of Patients With Gingivitis: a Randomised Study
- ClinicalTrials.gov ID
- NCT07005011
- Acronym / sponsor ID
- Hydro-Paro / 2024_RIPH_30_Hydro-Paro
- Conditions
- Gingivitis
- Keywords
- Gingivitis, oral irrigator, interdental brushes, interdental hygiene
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: "oral irrigator" group | Experimental | Other: oral irrigatorgroup 1: patients using oral irrigator as interdental hygiene tools |
| group2: "calibrated interdental brushes" group | Active comparator | Other: oral irrigatorgroup 2: patients using calibrated interdental brushes as interdental hygiene tools |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral irrigatororal irrigator | Other | group 1: "oral irrigator" group, group2: "calibrated interdental brushes" group |
Primary outcome
Approximal plaque index (API - Lange, 1977)
Time frame: 12 weeks
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.
3 secondary outcomes
Plaque control record (PCR - O'Lheary et al., 1972)
Time frame: 12 weeks
Bleeding on probing (BOP - Ainamo et Bay, 1975)
Time frame: 12 weeks
General Oral Health Assessment Index (GOHAI - Tubert-Jeanin et al., 2003)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing oral irrigator in people with Gingivitis, run by Université de Reims Champagne-Ardenne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbe Coralie, DR (03 26 91 36 65 ext. +33, coralie.barbe1@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Approximal plaque index (API - Lange, 1977) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.