Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate (NCT03750708) | Clinical Trial Compass
WithdrawnNot Applicable
Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate
Stopped: Unsuccessful study
France0Started 2019-01-28
Plain-language 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.
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).
Who can participate
Age range
4 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oral hygiene score : CAO
Timeframe: Consultation 1 month before alveolar bone graft
2
Oral hygiene score : CPITN
Timeframe: Consultation 1 month before alveolar bone graft
3
Oral hygiene score : Silness-Löe Index
Timeframe: Consultation 1 month before alveolar bone graft
4
Changes in oral hygiene score : CAO
Timeframe: Consultation 1 day before alveolar bone graft
5
Changes in oral hygiene score : CPITN
Timeframe: Consultation 1 day before alveolar bone graft
6
Changes in oral hygiene score : Silness-Löe Index
Timeframe: Consultation 1 day before alveolar bone graft