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Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate (HBD-GPP)

Primary Purpose

Cleft Lip and Palate

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ara® KOLIBREE tooth brush
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cleft Lip and Palate focused on measuring Alveolar bone graft complications, oral hygiene, cleft lip and palate, connected health

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Necker - Enfants Malades

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Ara® KOLIBREE toothbrush

Without Ara® KOLIBREE tooth brush

Arm Description

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

Usual consultation one month before alveolar bone graft.

Outcomes

Primary Outcome Measures

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.
Oral hygiene score : CPITN
CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
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).
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.
Changes in oral hygiene score : CPITN
CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
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).

Secondary Outcome Measures

Description of the use of the Ara ® Toothbrush
Recorded data from the use of the Ara ® KOLIBREE tooth brush (Kolibree Pro interface)
Occurrence of post-operative complications
Delays in scarring, scar dehiscence, fistulas, infections of the surgical site, total or partial losses of the graft

Full Information

First Posted
November 13, 2018
Last Updated
November 7, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03750708
Brief Title
Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate
Acronym
HBD-GPP
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unsuccessful study
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
Alveolar bone graft complications, oral hygiene, cleft lip and palate, connected health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ara® KOLIBREE toothbrush
Arm Type
Other
Arm Description
The Ara® KOLIBREE tooth brush is given to the child at the usual consultation one month before alveolar bone graft.
Arm Title
Without Ara® KOLIBREE tooth brush
Arm Type
No Intervention
Arm Description
Usual consultation one month before alveolar bone graft.
Intervention Type
Device
Intervention Name(s)
Ara® KOLIBREE tooth brush
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oral hygiene score : CAO
Description
Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.
Time Frame
Consultation 1 month before alveolar bone graft
Title
Oral hygiene score : CPITN
Description
CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
Time Frame
Consultation 1 month before alveolar bone graft
Title
Oral hygiene score : Silness-Löe Index
Description
Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Time Frame
Consultation 1 month before alveolar bone graft
Title
Changes in oral hygiene score : CAO
Description
Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.
Time Frame
Consultation 1 day before alveolar bone graft
Title
Changes in oral hygiene score : CPITN
Description
CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
Time Frame
Consultation 1 day before alveolar bone graft
Title
Changes in oral hygiene score : Silness-Löe Index
Description
Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Time Frame
Consultation 1 day before alveolar bone graft
Secondary Outcome Measure Information:
Title
Description of the use of the Ara ® Toothbrush
Description
Recorded data from the use of the Ara ® KOLIBREE tooth brush (Kolibree Pro interface)
Time Frame
Consultation at 1 day before alveolar bone graft
Title
Occurrence of post-operative complications
Description
Delays in scarring, scar dehiscence, fistulas, infections of the surgical site, total or partial losses of the graft
Time Frame
Consultation 6 months after alveolar bone graft

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Hossein Khonsari, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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