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

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ClinicalTrials.gov Identifier: NCT03750708
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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).


Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Device: Ara® KOLIBREE tooth brush Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Ara® KOLIBREE toothbrush
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

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.
No Intervention: Without Ara® KOLIBREE tooth brush
Usual consultation one month before alveolar bone graft.


Outcome Measures
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Primary Outcome Measures :
  1. Oral hygiene score : CAO [ Time Frame: Consultation 1 month before alveolar bone graft ]
    Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.

  2. Oral hygiene score : CPITN [ Time Frame: Consultation 1 month before alveolar bone graft ]
    CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).

  3. Oral hygiene score : Silness-Löe Index [ Time Frame: Consultation 1 month before alveolar bone graft ]
    Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).

  4. Changes in oral hygiene score : CAO [ Time Frame: Consultation 1 day before alveolar bone graft ]
    Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.

  5. Changes in oral hygiene score : CPITN [ Time Frame: Consultation 1 day before alveolar bone graft ]
    CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).

  6. Changes in oral hygiene score : Silness-Löe Index [ Time Frame: Consultation 1 day before alveolar bone graft ]
    Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).


Secondary Outcome Measures :
  1. Description of the use of the Ara ® Toothbrush [ Time Frame: Consultation at 1 day before alveolar bone graft ]
    Recorded data from the use of the Ara ® KOLIBREE tooth brush (Kolibree Pro interface)

  2. Occurrence of post-operative complications [ Time Frame: Consultation 6 months after alveolar bone graft ]
    Delays in scarring, scar dehiscence, fistulas, infections of the surgical site, total or partial losses of the graft


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750708


Contacts
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Contact: Roman Hossein Khonsari, MD PhD +33 1 71 39 66 13 roman.khonsari@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr

Locations
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France
Hôpital Necker - Enfants Malades Recruiting
Paris, France, 75015
Contact: Roman Hossein Khonsari, MD PhD    +33 1 71 39 66 13    roman.khonsari@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Roman Hossein Khonsari, MD PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03750708    
Other Study ID Numbers: APHP180025
2018-A02062-53 ( Registry Identifier: ID-RCB )
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Alveolar bone graft complications, oral hygiene, cleft lip and palate, connected health
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
 Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities