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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. 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).
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).
Age
4 - 11 years
Sex
ALL
Healthy Volunteers
No
Hôpital Necker - Enfants Malades
Paris, France
Start Date
January 28, 2019
Primary Completion Date
February 28, 2021
Completion Date
February 28, 2021
Last Updated
March 16, 2026
Ara® KOLIBREE tooth brush
DEVICE
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
NCT06683560
NCT06408337
NCT02702869
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