Alveolar Bone Grafting Outcome Between Patient With and Without Orthodontic Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02454998|
Recruitment Status : Unknown
Verified February 2015 by Chang Gung Memorial Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 27, 2015
Last Update Posted : May 27, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cleft Lip||Other: orthodontic treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||August 2015|
Experimental: Orthodontic treatment arm
Previous to the surgical alveolar bone grafting, orthodontic treatment is performed several months before surgery
Other: orthodontic treatment
Braces on the upper dental arch previous to surgical alveolar bone grafting. the goal is optimizing the structure of dental-alveolar structure.
No Intervention: No orthodontic treatment arm
No orthodontic treatment previous to surgical alveolar bone grafting
- 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
- Infection rate [ Time Frame: up to 6 months ]Evaluate the infection rate after surgery
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): NCT02454998
|Study Chair:||Philip Kuo-Ting Chen, M.D.||Chang Gung Memorial Hospital|