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Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate

NCT03750708 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-03-16

No results posted yet for this study

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).

Conditions

  • Cleft Lip and Palate

Interventions

DEVICE

Ara® KOLIBREE tooth brush

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.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Roman Hossein Khonsari, MD PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750708 on ClinicalTrials.gov