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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. 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
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Cleft Lip Other: orthodontic treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

Secondary Outcome Measures :
  1. Infection rate [ Time Frame: up to 6 months ]
    Evaluate the infection rate after surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Unilateral complete cleft lip patients
  2. Alveolar bone cleft diagnosed with conventional radiographic study
  3. Patients at the stage of mixed dentition.
  4. Informed consent signed by the parents or custodians.

Exclusion Criteria:

  1. Presentation of other craniofacial anomalies.
  2. Parents or custodians who do not agreed to this procedure.

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 identifier (NCT number): NCT02454998

Sponsors and Collaborators
Chang Gung Memorial Hospital
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Study Chair: Philip Kuo-Ting Chen, M.D. Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital Identifier: NCT02454998    
Other Study ID Numbers: 102-3500C (99-3910A3)
CMRPG3B0201-3 ( Other Grant/Funding Number: Chang Gung Memorial Hospital research grant )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: February 2015
Keywords provided by Chang Gung Memorial Hospital:
Unilateral complete cleft lip
Alveolar bone graft
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities