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

NCT03750708 | Withdrawn

• 2 other identifiers: APHP1800252018-A02062-53
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Cleft Lip and Palate

Keywords

Alveolar bone graft complications, oral hygiene, cleft lip and palate, connected health

Outcome Measures

Primary Outcomes (6)

• Oral hygiene score : CAO

  Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.

  Consultation 1 month before alveolar bone graft

• Oral hygiene score : CPITN

  CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).

  Consultation 1 month before alveolar bone graft

• Oral hygiene score : Silness-Löe Index

  Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).

  Consultation 1 month before alveolar bone graft

• Changes in oral hygiene score : CAO

  Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.

  Consultation 1 day before alveolar bone graft

• Changes in oral hygiene score : CPITN

  CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).

  Consultation 1 day before alveolar bone graft

• Changes in oral hygiene score : Silness-Löe Index

  Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).

  Consultation 1 day before alveolar bone graft

Secondary Outcomes (2)

• Description of the use of the Ara ® Toothbrush

  Consultation at 1 day before alveolar bone graft

• Occurrence of post-operative complications

  Consultation 6 months after alveolar bone graft

Study Arms (2)

Ara® KOLIBREE toothbrush

OTHER

The Ara® KOLIBREE tooth brush is given to the child at the usual consultation one month before alveolar bone graft.

Device: Ara® KOLIBREE tooth brush

Without Ara® KOLIBREE tooth brush

NO INTERVENTION

Usual consultation one month before alveolar bone graft.

Interventions

Ara® KOLIBREE tooth brush DEVICE

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.

Ara® KOLIBREE toothbrush

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker - Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Roman Hossein Khonsari, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 23, 2018
• Study Start: January 28, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)