Clinical trial NCT03750708: Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: Alveolar bone graft complications, oral hygiene, cleft lip and palate, connected health
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Oral hygiene score : CAO
timeFrame: Consultation 1 month before alveolar bone graft
measure: Oral hygiene score : CPITN
timeFrame: Consultation 1 month before alveolar bone graft
measure: Oral hygiene score : Silness-Löe Index
timeFrame: Consultation 1 month before alveolar bone graft
measure: Changes in oral hygiene score : CAO
timeFrame: Consultation 1 day before alveolar bone graft
measure: Changes in oral hygiene score : CPITN
timeFrame: Consultation 1 day before alveolar bone graft
measure: Changes in oral hygiene score : Silness-Löe Index
timeFrame: Consultation 1 day before alveolar bone graft
Secondary outcomes:
measure: Description of the use of the Ara ® Toothbrush
timeFrame: Consultation at 1 day before alveolar bone graft
measure: Occurrence of post-operative complications
timeFrame: Consultation 6 months after alveolar bone graft
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker - Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Roman Hossein Khonsari, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: