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.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Oral hygiene score : CAO
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ara® KOLIBREE toothbrush
The Ara® KOLIBREE tooth brush is given to the child at the usual consultation one month before alveolar bone graft.
干预措施: Ara® KOLIBREE tooth brush (Device)
Without Ara® KOLIBREE tooth brush
Usual consultation one month before alveolar bone graft.
结局指标
主要结局
Oral hygiene score : CAO
时间窗: 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.
Oral hygiene score : Silness-Löe Index
时间窗: 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).
Changes in oral hygiene score : CPITN
时间窗: Consultation 1 day before alveolar bone graft
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
时间窗: 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).
Changes in oral hygiene score : CAO
时间窗: 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.
Oral hygiene score : CPITN
时间窗: Consultation 1 month before alveolar bone graft
CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
次要结局
- 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)