Clinical Trial: Alveolar Bone Grafting Outcome Between Patient With and Without Orthodontic Treatment

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Difference in the Surgical Outcome of Unilateral Cleft Lip and Palate Between Patients With and Without Pre-Alveolar Bone Graft Orthodontic Treatment

Brief Summary:

Alveolar bone grafting (ABG) is an essential part of the surgical management of cleft lip and palate patients. This procedure could obliterate oronasal fistula, stabilize dental arch, offer bone matrix for adjacent teeth eruption. Moreover, by obliterating oronasal fistula, we stop the chronic irritation of nasal mucosa by oral content. Hence, the symptoms of rhinorrhea or nasal obstruction could be improved. This dental arch defect could predispose further dental arch medial collapse. Without alveolar bone grafting the dental arch is not stable, dental movement during orthodontic treatment is limited and dental arch expansion is not possible.

Previous to operation, the patient suffered from dental crowding and dental inclination toward to the cleft. This produces a difficult dental hygiene and predispose to dental caries and gingivitis. Pre-operative orthodontics treatment is advised in many centers. By aligned the teeth previous to surgery, with a better dental hygiene, we purpose that the infection rate will be reduced and success rate will be better.

The Purpose of this study is to determine whether pre-operative orthopedic treatment will affect secondary alveolar bone grafting outcome and to assess the nasal change after alveolar bone graft.

Detailed Summary:

Overall goals of study:

The goals of this study are to determine whether pre-operative orthodontic treatment will affect secondary alveolar bone grafting outcome

Importance of alveolar bone grafting Alveolar bone cleft is present in the majority of patients with cleft lip and palate. This bone cleft destabilizes the maxillary arch and predisposes it to medial collapse. Teeth will not erupt in this region of alveolar bone defect. Permanent stabilization of the maxillary segments into a functional dental arch form is achieved by reconstruction of alveolar with bone grafts. The goals of alveolar bone grafting are to maintain normal occlusion and to provide a matrix for the continued eruption of permanent teeth in this region. Moreover, future maxillary expansion cannot be done unless repair of the alveolar cleft is coordinated with the desired orthodontic movement.

Timing of alveolar bone grafting Maxillary growth and dental age are the predominant considerations in determining the timing of alveolar reconstruction. Maxillary growth is completed near the age of eight years old, whereas the maxillary canine does not erupt before the age of ten.Therefore, to minimize growth disturbance to the maxilla, reconstruction should be performed after the growth is completed.It has been widely agreed that the timing of alveolar grafting should be around the stage of mixed dentition . The bone grafting should be completed at approximately nine years of age when the bulk of the alveolar bone growth is completed and the incisors are erupted, while the lateral incisors and canines are starting to erupt into alveolar cleft region

Diagnosis Radiographic studies, including panoramic radiographs, selected periapical films, Cephalographic films and
Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome:

• Pre-orthodontic alveolar bone defect [ Time Frame: Before surgical and orthodontic treatment, A expected average of 6 months before surgery ]
  CT scan, measurement of alveolar bone cleft defect volume
• Pre-surgical alveolar bone defect [ Time Frame: Before surgical treatment (alveolar bone cleft), a expected average of 6 months of orthodontic treatment ]
  CT scan, measurement of alveolar bone cleft defect volume
• Alveolar bone graft survival [ Time Frame: A expected average of 6 months after surgery ]
  CT scan, measurement of volume of bone graft filling the alveolar bone cleft

Original Primary Outcome: Same as current

Current Secondary Outcome: Infection rate [ Time Frame: up to 6 months ]

Original Secondary Outcome: Same as current

Information By: Chang Gung Memorial Hospital

Dates:
Date Received: February 17, 2015
Date Started: February 2011
Date Completion: August 2015
Last Updated: May 26, 2015
Last Verified: February 2015