Status:
WITHDRAWN
Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Cleft Lip and Palate
Eligibility:
All Genders
4-11 years
Phase:
NA
Brief 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 b...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03750708
Start Date
January 28 2019
End Date
February 28 2021
Last Update
September 25 2025
Active Locations (1)
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1
Hôpital Necker - Enfants Malades
Paris, France, 75015