Pregnant WomanPRE-IOPNCT05945225
Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP)
A study testing Sonicare DiamondClean 9000 Philips®, HydroSonic Easy Curaden® and Manual toothbrush Oral-B 123 in people with Pregnant Woman, run by Claude Bernard University at 1 site in France.
Trial summary
Gingivitis in pregnant women is a common inflammatory periodontal disease that appears from the third month of pregnancy with an overall prevalence of 35 to 100%. This condition is induced by oral biofilm and exacerbated by increased levels of sex steroid hormones characteristic of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnant Woman
- What is being tested?
- Sonicare DiamondClean 9000 Philips®, HydroSonic Easy Curaden® and Manual toothbrush Oral-B 123
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 30 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, 18 to 40 years of age
- 15-18 weeks pregnant
- Acceptance of study terms and conditions
- Signature of informed consent form
Who cannot join
- Protected women
- Stage II,III periodontal disease (i.e. PD ≥ 4 mm, and/or CAL ≥ 4 mm), generalized (>30% od sites)
- History or treatment of periodontal disease
- Current dental or orthodontic treatment
- Fewer than 20 natural teeth, excluding third molars
- Taking medication affecting the gums and/or oral mucosa
Show all 12Show fewer
- Regular use (more than once a week) of interdental brushes and/or dental floss and/or mouthwash
- Removable prosthesis
- Dental implants
- Systemic disorder such as blood disorders, diabetes, and risk of endocarditis infections
- Anticoagulant treatment
- Inability to follow protocol or non-cooperation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Comparison of Two Sonic Electric Toothbrushes and Two Manual Toothbrushes, Used Under Normal Oral Hygiene Conditions, on the Reduction of Gingival Inflammation in Pregnant Women Aged 18 to 40: Randomized Clinical Trial
Gingivitis in pregnant women is a common inflammatory periodontal disease that appears from the third month of pregnancy with an overall prevalence of 35 to 100%. This condition is induced by oral biofilm and exacerbated by increased levels of sex steroid hormones characteristic of pregnancy. Strict bacterial plaque control with both professional and home oral hygiene is essential. Manual toothbrushes require a more specific manual technique for women, while sonic electric toothbrushes, due to their ease of use, might be an excellent for oral individual prophylaxis. Therefore, the question of which type of manual or electric toothbrush might be more effective in reducing gingival inflammation in pregnant women is still unresolved. In literature there are a large number of in vitro clinical studies on this topic, there are currently no clinical studies investigating this long-term clinical comparison.
In this context, this study is a randomized clinical trial consisting of a comparative evaluation between two manual and two sonic electric toothbrushes in the efficacy of the control of plaque in order to reduce gingivitis in women during the period of pregnancy.
- Conditions
- Pregnant Woman
- Being tested
- Sonicare DiamondClean 9000 Philips®, HydroSonic Easy Curaden®, Manual toothbrush Oral-B 123, Manual toothbrush Curaprox CS 5460
- Keywords
- manual toothbrush, electric sonic toothbrush, oral prophylaxis, pregnant woman, gingival inflammation
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonicare DiamondClean 9000 Philips®Device
Brush teeth with the electric toothbrush daily during 3 months
HydroSonic Easy Curaden®Device
Brush teeth with the hydrosonic toothbrush daily during 3 months
Manual toothbrush Oral-B 123Device
Brush teeth with the manual toothbrush daily during 3 months
Manual toothbrush Curaprox CS 5460Device
Brush teeth with the manual toothbrush daily during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group using sonic toothbrush | Experimental | Patient will be asked to use a sonic toothbrush for 3 months Receives: Device: Sonicare DiamondClean 9000 Philips® |
| Group using hydrosonic toothbrush | Experimental | Patient will be asked to use a hydrosonic toothbrush for 3 months Receives: Device: HydroSonic Easy Curaden® |
| Group using manual toothbrush with 5460 strands | Experimental | Patients will be asked to use a manual toothbrush with 5460 strands for 3 months Receives: Device: Manual toothbrush Curaprox CS 5460 |
| Group using manual toothbrush | Placebo comparator | Patients will be asked to use a manual toothbrush for 3 months Receives: Device: Manual toothbrush Oral-B 123 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gingival bleeding from baseline during woman pregnancy
Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice
Measured: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Secondary outcomes (6)
Effect on gingival bleeding
Bleeding on Probing
Measured: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on gingival inflammation
gingival index
Measured: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on dental plaque
plaque index
Measured: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on gingival attachment
clinical attachment loss
Measured: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on Periodontal Pocket
Periodontal Pocket Probing Depth
Measured: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Customer Satisfaction Score
- the minimum and maximum values: 1, 7
- lower scores mean a worse outcome.
- the minimum and maximum values: 1, 7
- lower scores mean a worse outcome.
- the minimum and maximum values: 1, 7
- lower scores mean a worse outcome. The score range from 1 (minimum) to 7 (maximum). Lower score mean a worse outcome
Measured: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Nov 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomanStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nancy, Elsan
- Responsible party
- Principal investigator, Carrouel Florence, Claude Bernard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945225
- Sponsor's protocol ID
- PRE-IOP
- Acronym
- PRE-IOP
- Status last verified
- Mar 2026
- First submitted
- 6 Jul 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Two Sonic Electric Toothbrushes and Two Manual Toothbrushes, Used Under Normal Oral Hygiene Conditions, on the Reduction of Gingival Inflammation in Pregnant Women Aged 18 to 40: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05945225
- Acronym / sponsor ID
- PRE-IOP / PRE-IOP
- Conditions
- Pregnant Woman
- Keywords
- manual toothbrush, electric sonic toothbrush, oral prophylaxis, pregnant woman, gingival inflammation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Collaborators
- University of Nancy, Elsan
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Jul 2023 (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.
Gingivitis in pregnant women is a common inflammatory periodontal disease that appears from the third month of pregnancy with an overall prevalence of 35 to 100%. This condition is induced by oral biofilm and exacerbated by increased levels of sex steroid hormones characteristic of pregnancy. Strict bacterial plaque control with both professional and home oral hygiene is essential. Manual toothbrushes require a more specific manual technique for women, while sonic electric toothbrushes, due to their ease of use, might be an excellent for oral individual prophylaxis. Therefore, the question of which type of manual or electric toothbrush might be more effective in reducing gingival inflammation in pregnant women is still unresolved. In literature there are a large number of in vitro clinical studies on this topic, there are currently no clinical studies investigating this long-term clinical comparison.
In this context, this study is a randomized clinical trial consisting of a comparative evaluation between two manual and two sonic electric toothbrushes in the efficacy of the control of plaque in order to reduce gingivitis in women during the period of pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group using sonic toothbrush | Experimental | Device: Sonicare DiamondClean 9000 Philips®Patient will be asked to use a sonic toothbrush for 3 months |
| Group using hydrosonic toothbrush | Experimental | Device: HydroSonic Easy Curaden®Patient will be asked to use a hydrosonic toothbrush for 3 months |
| Group using manual toothbrush with 5460 strands | Experimental | Device: Manual toothbrush Curaprox CS 5460Patients will be asked to use a manual toothbrush with 5460 strands for 3 months |
| Group using manual toothbrush | Placebo comparator | Device: Manual toothbrush Oral-B 123Patients will be asked to use a manual toothbrush for 3 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, 18 to 40 years of age
- 15-18 weeks pregnant
- Acceptance of study terms and conditions
- Signature of informed consent form
Key exclusion criteria (12 listed)
- Protected women
- Stage II,III periodontal disease (i.e. PD ≥ 4 mm, and/or CAL ≥ 4 mm), generalized (>30% od sites)
- History or treatment of periodontal disease
- Current dental or orthodontic treatment
- Fewer than 20 natural teeth, excluding third molars
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 |
|---|---|---|
| Sonicare DiamondClean 9000 Philips®Brush teeth with the electric toothbrush daily during 3 months | Device | Group using sonic toothbrush |
| HydroSonic Easy Curaden®Brush teeth with the hydrosonic toothbrush daily during 3 months | Device | Group using hydrosonic toothbrush |
| Manual toothbrush Oral-B 123Brush teeth with the manual toothbrush daily during 3 months | Device | Group using manual toothbrush |
| Manual toothbrush Curaprox CS 5460Brush teeth with the manual toothbrush daily during 3 months | Device | Group using manual toothbrush with 5460 strands |
Primary outcome
Incidence of gingival bleeding from baseline during woman pregnancy
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice
6 secondary outcomes
Effect on gingival bleeding
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on gingival inflammation
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on dental plaque
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on gingival attachment
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Effect on Periodontal Pocket
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
Customer Satisfaction Score
Time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)
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 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonicare DiamondClean 9000 Philips®, HydroSonic Easy Curaden® and Manual toothbrush Oral-B 123 in people with Pregnant Woman, run by Claude Bernard University at 1 site in France.
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 4 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gingival bleeding from baseline during woman pregnancy (time frame: T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months)). 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 18 Mar 2026.