Cleft Lip and PalateHBD-GPPNCT03750708
Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate
A study testing Ara® KOLIBREE tooth brush in people with Cleft Lip and Palate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an autologous iliac bone graft. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Ara® KOLIBREE tooth brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5 to 12 years.
- Children benefiting from iliac alveolar bone graft (first side for bilateral clefts) as part of the surgical management of unilateral a bilateral cleft lip and palate.
- Children benefiting from a pre-operative orthodontic treatment using Quad Helix type (usual protocol).
- Collection of the consent of the persons holding the parental authority and of the child participating in the study.
- Affiliation to social security.
Who cannot join
- Cognitive impairment preventing the satisfactory education for the use of the connected device.
- Chronic disease potentially favouring dental infections (congenital or acquired immunosuppression, congenital enamel disease).
- Children undergoing secondary alveolar bone grafts (after an unsatisfactory first alveolar bone graft) or undergoing surgery for the second side in bilateral clefts.
- Children participating in another interventional research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Impact of the Use of the ARA 2 Connected Toothbrush on Short-term Oral Hygiene During the Pre-operative Period of Alveolar Bone Grafts for Patients With Unilateral or Bilateral Cleft Lip and Palate. Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate.
Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an autologous iliac bone graft.
Clinical experience suggests that a large number of the post-operative complications in this procedure are related to pre-and post-operative oral hygiene issues.
Read more
The main objective of this research is the evaluation of pre-operative oral hygiene in children benefiting from alveolar bone graft and having a type Quad Helix orthodontic device.
The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has an influence on the occurrence of post-operative complications evaluated at 6 months of intervention (delays in scarring, suture dehiscence, fistulas, surgical site infections, total or partial graft loss).
Read the detailed description
Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an autologous iliac bone graft.
Clinical experience suggests that many post-operative complications in alveolar bone grafts are related to pre- and post-operative oral hygiene issues. This surgical procedure therefore requires optimal pre-and post-operative oral hygiene.
In addition, children with cleft lip and palate have a higher risk of oral hygiene issues, partly due to the systematic use of orthodontic devices such as Quad Helix.
Prevention of post-operative complications (delays in scarring, scar dehiscence, fistulas, infections of the surgical site, total or partial losses of the graft) requires patient education efforts in order to improve pre-operative oral hygiene.
Connected devices allow an objective follow-up tooth brushing and could be effective instruments in the primary and secondary prevention of pre-and post-operative complications linked to the alveolar bone graft, via a better oral hygiene.
Connected health is a growing and promising technology. It is important for physicians to demonstrate the efficiency of connected objects. Recent medico-economic studies have demonstrated the added value of connected devices as part of a general health monitoring, but more prospective assessments are required, especially in pediatric populations. Also, because of its importance in terms of public health, the field of oral hygiene is at the forefront of connected health applications.
The main objective of the research is the evaluation of pre-operative oral hygiene of children benefiting from an alveolar bone graft and having a type Quad Helix orthodontic device.
The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has an influence on the occurrence of post-operative complications evaluated at 6 months of intervention (delays in scarring, scar dehiscence, fistulas, surgical site infections, total or partial losses of the graft).
- Conditions
- Cleft Lip and Palate
- Being tested
- Ara® KOLIBREE tooth brush
- Keywords
- Alveolar bone graft complications, oral hygiene, cleft lip and palate, connected health
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ara® KOLIBREE tooth brushDevice
Use of the Ara® KOLIBREE tooth brush by the child one month before alveolar bone graft up to the time of surgery.
The Ara® KOLIBREE tooth brush saves brush tracking data.
| Study group | Role | What they receive |
|---|---|---|
| Ara® KOLIBREE toothbrush | Other | The Ara® KOLIBREE tooth brush is given to the child at the usual consultation one month before alveolar bone graft. Receives: Device: Ara® KOLIBREE tooth brush |
| Without Ara® KOLIBREE tooth brush | No intervention | Usual consultation one month before alveolar bone graft. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral hygiene score : CAO
Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.
Measured: Consultation 1 month before alveolar bone graft
Oral hygiene score : CPITN
CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
Measured: Consultation 1 month before alveolar bone graft
Oral hygiene score : Silness-Löe Index
Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Measured: Consultation 1 month before alveolar bone graft
Changes in oral hygiene score : CAO
Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.
Measured: Consultation 1 day before alveolar bone graft
Changes in oral hygiene score : CPITN
CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
Measured: Consultation 1 day before alveolar bone graft
Changes in oral hygiene score : Silness-Löe Index
Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Measured: Consultation 1 day before alveolar bone graft
Secondary outcomes (2)
Description of the use of the Ara ® Toothbrush
Recorded data from the use of the Ara ® KOLIBREE tooth brush (Kolibree Pro interface)
Measured: Consultation at 1 day before alveolar bone graft
Occurrence of post-operative complications
Delays in scarring, scar dehiscence, fistulas, infections of the surgical site, total or partial losses of the graft
Measured: Consultation 6 months after alveolar bone graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start28 Jan 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Unsuccessful study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Roman Hossein Khonsari, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750708
- Sponsor's protocol ID
- APHP180025
- Other IDs
- 2018-A02062-53
- Acronym
- HBD-GPP
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2018
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of the Use of the ARA 2 Connected Toothbrush on Short-term Oral Hygiene During the Pre-operative Period of Alveolar Bone Grafts for Patients With Unilateral or Bilateral Cleft Lip and Palate. Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate.
- ClinicalTrials.gov ID
- NCT03750708
- Acronym / sponsor ID
- HBD-GPP / APHP180025
- Conditions
- Cleft Lip and Palate
- Keywords
- Alveolar bone graft complications, oral hygiene, cleft lip and palate, connected health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unsuccessful study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 23 Nov 2018 (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.
Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an autologous iliac bone graft.
Clinical experience suggests that a large number of the post-operative complications in this procedure are related to pre-and post-operative oral hygiene issues.
The main objective of this research is the evaluation of pre-operative oral hygiene in children benefiting from alveolar bone graft and having a type Quad Helix orthodontic device.
The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has an influence on the occurrence of post-operative complications evaluated at 6 months of intervention (delays in scarring, suture dehiscence, fistulas, surgical site infections, total or partial graft loss).
Detailed description
Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an autologous iliac bone graft.
Clinical experience suggests that many post-operative complications in alveolar bone grafts are related to pre- and post-operative oral hygiene issues. This surgical procedure therefore requires optimal pre-and post-operative oral hygiene.
In addition, children with cleft lip and palate have a higher risk of oral hygiene issues, partly due to the systematic use of orthodontic devices such as Quad Helix.
Prevention of post-operative complications (delays in scarring, scar dehiscence, fistulas, infections of the surgical site, total or partial losses of the graft) requires patient education efforts in order to improve pre-operative oral hygiene.
Connected devices allow an objective follow-up tooth brushing and could be effective instruments in the primary and secondary prevention of pre-and post-operative complications linked to the alveolar bone graft, via a better oral hygiene.
Connected health is a growing and promising technology. It is important for physicians to demonstrate the efficiency of connected objects. Recent medico-economic studies have demonstrated the added value of connected devices as part of a general health monitoring, but more prospective assessments are required, especially in pediatric populations. Also, because of its importance in terms of public health, the field of oral hygiene is at the forefront of connected health applications.
The main objective of the research is the evaluation of pre-operative oral hygiene of children benefiting from an alveolar bone graft and having a type Quad Helix orthodontic device.
The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has an influence on the occurrence of post-operative complications evaluated at 6 months of intervention (delays in scarring, scar dehiscence, fistulas, surgical site infections, total or partial losses of the graft).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ara® KOLIBREE toothbrush | Other | Device: Ara® KOLIBREE tooth brushThe Ara® KOLIBREE tooth brush is given to the child at the usual consultation one month before alveolar bone graft. |
| Without Ara® KOLIBREE tooth brush | No intervention | –Usual consultation one month before alveolar bone graft. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 5 to 12 years.
- Children benefiting from iliac alveolar bone graft (first side for bilateral clefts) as part of the surgical management of unilateral a bilateral cleft lip and palate.
- Children benefiting from a pre-operative orthodontic treatment using Quad Helix type (usual protocol).
- Collection of the consent of the persons holding the parental authority and of the child participating in the study.
- Affiliation to social security.
Key exclusion criteria (4 listed)
- Cognitive impairment preventing the satisfactory education for the use of the connected device.
- Chronic disease potentially favouring dental infections (congenital or acquired immunosuppression, congenital enamel disease).
- Children undergoing secondary alveolar bone grafts (after an unsatisfactory first alveolar bone graft) or undergoing surgery for the second side in bilateral clefts.
- Children participating in another interventional research.
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 |
|---|---|---|
| Ara® KOLIBREE tooth brushUse of the Ara® KOLIBREE tooth brush by the child one month before alveolar bone graft up to the time of surgery. The Ara® KOLIBREE tooth brush saves brush tracking data. | Device | Ara® KOLIBREE toothbrush |
Primary outcome
Oral hygiene score : CAO
Time frame: Consultation 1 month before alveolar bone graft
Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.
Oral hygiene score : CPITN
Time frame: Consultation 1 month before alveolar bone graft
CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
Oral hygiene score : Silness-Löe Index
Time frame: Consultation 1 month before alveolar bone graft
Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Changes in oral hygiene score : CAO
Time frame: Consultation 1 day before alveolar bone graft
Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.
Changes in oral hygiene score : CPITN
Time frame: Consultation 1 day before alveolar bone graft
CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
Changes in oral hygiene score : Silness-Löe Index
Time frame: Consultation 1 day before alveolar bone graft
Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
2 secondary outcomes
Description of the use of the Ara ® Toothbrush
Time frame: Consultation at 1 day before alveolar bone graft
Occurrence of post-operative complications
Time frame: Consultation 6 months after alveolar bone graft
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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. This study is not recruiting at the moment.
Roman Hossein Khonsari, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ara® KOLIBREE tooth brush in people with Cleft Lip and Palate, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 16 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Oral hygiene score : CAO (time frame: Consultation 1 month before alveolar bone graft). The study lists 6 primary outcomes in all. 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 16 Mar 2026.