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Alveolar Bone Grafting Outcome Between Patient With and Without Orthodontic Treatment

Primary Purpose

Cleft Lip

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
orthodontic treatment
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip focused on measuring Unilateral complete cleft lip, Alveolar bone graft

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Orthodontic treatment arm

    No orthodontic treatment arm

    Arm Description

    Previous to the surgical alveolar bone grafting, orthodontic treatment is performed several months before surgery

    No orthodontic treatment previous to surgical alveolar bone grafting

    Outcomes

    Primary Outcome Measures

    Pre-orthodontic alveolar bone defect
    CT scan, measurement of alveolar bone cleft defect volume
    Pre-surgical alveolar bone defect
    CT scan, measurement of alveolar bone cleft defect volume
    Alveolar bone graft survival
    CT scan, measurement of volume of bone graft filling the alveolar bone cleft

    Secondary Outcome Measures

    Infection rate
    Evaluate the infection rate after surgery

    Full Information

    First Posted
    February 17, 2015
    Last Updated
    May 26, 2015
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02454998
    Brief Title
    Alveolar Bone Grafting Outcome Between Patient With and Without Orthodontic 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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    July 2015 (Anticipated)
    Study Completion Date
    August 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 Description
    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 recently CT scan are integral parts for diagnosis and evaluation. They provide important assessments of the pre-operative dentition in the vicinity of the cleft, the dimensions and structures of cleft itself as well as postoperative condition of the bone bridge after alveolar bone grafting.The CT scan offers more detailed pre-operative and post-operative bone structures with less distortion. Additionally, CT scan also provide: 1. Detailed information about the depth and volume of bone deposited in the cleft, 2. More consistent in showing bone trabeculation, 3. Detailed position of erupting teeth relative to the bone graft, 4. More detailed bone and teeth anatomy for clinical orthodontics decisions. In addition, the CT scan could offer 3D lineal measurements and volumetric analysis . Arai et al. developed a novel cone-bean CT (CBCT) or Ortho CT which has important characteristics such as lowered radiation dose and the ability to produce higher resolution compared to conventional spiral CT. Several reports have indicated that it is clinical useful for the 3D imaging diagnosis in the maxillofacial region. Pre-operative orthodontic treatment The orthodontists form an integral part in the cleft care. Their recommendations regarding timing of treatment should be carefully considered before surgical treatment. The dental crowding and malposition of the teeth around the cleft can interfere with oral hygiene . The goal of the preoperative orthodontic treatment is to optimizing the position of dentoalveolar structure which enables the patients to have better oral hygiene prior to the operation. Some centers have recommended that the orthodontic treatment become part of the treatment protocol for their patients However, the presurgical orthodontics treatment is time consuming as the children are required to visit the clinic for monthly orthodontic adjustment. The average duration of the orthodontic treatments before operation is 6 months. These factors not only add discomfort to the children but also create significant financial burden to the parents. Even this primary orthodontic treatment is able to align the upper dental arch; secondary orthodontic treatment is always needed after complete permanent teeth eruption. Therefore, the actual need of presurgical orthodontics remained questionable. No studies have yet to actually address the outcome of alveolar bone grafting with or without presurgical orthodontics. The primary goal of this present prospective randomize study is to determine whether pre-operative orthodontics treatment will affect secondary alveolar bone grafting outcome. Donor site selection: The bones used most commonly include the iliac crest, calvarial or tibia. Regardless of the donor site, cancellous bone is preferable to cortical or osteochondral graft . The iliac crest as a donor site is preferred because it has sufficient cancellous bone to fill even a large alveolar bone defect. Surgical procedures: The surgical procedures of alveolar bone graft are similar to the procedures that were described by Hall and Posnick et al. except with some minor modifications. With adequate general anesthesia via orotracheal intubation, two teams worked at the same time with one team harvesting the bone graft and the other team preparing the recipient site at the oral cavity. Attention was turned to the right hip where an oblique incision was made lateral and parallel to the iliac crest. The incision was deepened to the periosteum of the lateral cortex. The iliac crest was reflected medially as a bone flap. Cancellous bone chips was harvested. At the same time, the other team was working on the oral cavity. The mouth was suctioned and a throat pack was placed. The gingiva and upper buccal sulcus were infiltrated with 1% Xylocaine in 1:200,000 epinephrine solutions for hemostasis and easier dissection. Incisions were made along each side of the alveolar cleft. A superiorly based gingival mucoperiosteal flap was designed and raised sharply from the gingival margin on the lesser segment. The flap was extended posteriorly to the first molar. The incision was then curved up obliquely towards the buccal sulcus. The flap on the medial segment was elevated in a similar fashion towards the midline. The palatal mucoperiosteal flaps were raised to a level beyond the deepest margin of the alveolar fistula. The fistula margins at the palatal side were freshened and sutured. The nasal floor tissue could be completely separated from the palatal mucoperiosteum after raising the palatal flaps and could then be stripped off the bony cleft. The nasal floor tissue was dissected upward reaching the pyriform aperture on the lateral segment and the cartilaginous septum on the medial segment. This allowed a tension-free closure of nasal floor tissue and adequate correction of the vertical discrepancy of the nostril sill. The nasal floor fistula was securely repaired with 4-0 Vicryl sutures. Cancellous bone chips which were already harvested from iliac bone by another team were packed firmly into the bony defect to the level of the alveolar process and the pyriform aperture on the cleft side. The periosteum of the lateral gingival flap was scored to reduce the tension especially at the lateral end of the incision. The lateral gingival flap was then advanced and sutured to the medial flap and palatal flap to provide a watertight and tension free closure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cleft Lip
    Keywords
    Unilateral complete cleft lip, Alveolar bone graft

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Orthodontic treatment arm
    Arm Type
    Experimental
    Arm Description
    Previous to the surgical alveolar bone grafting, orthodontic treatment is performed several months before surgery
    Arm Title
    No orthodontic treatment arm
    Arm Type
    No Intervention
    Arm Description
    No orthodontic treatment previous to surgical alveolar bone grafting
    Intervention Type
    Other
    Intervention Name(s)
    orthodontic treatment
    Intervention Description
    Braces on the upper dental arch previous to surgical alveolar bone grafting. the goal is optimizing the structure of dental-alveolar structure.
    Primary Outcome Measure Information:
    Title
    Pre-orthodontic alveolar bone defect
    Description
    CT scan, measurement of alveolar bone cleft defect volume
    Time Frame
    Before surgical and orthodontic treatment, A expected average of 6 months before surgery
    Title
    Pre-surgical alveolar bone defect
    Description
    CT scan, measurement of alveolar bone cleft defect volume
    Time Frame
    Before surgical treatment (alveolar bone cleft), a expected average of 6 months of orthodontic treatment
    Title
    Alveolar bone graft survival
    Description
    CT scan, measurement of volume of bone graft filling the alveolar bone cleft
    Time Frame
    A expected average of 6 months after surgery
    Secondary Outcome Measure Information:
    Title
    Infection rate
    Description
    Evaluate the infection rate after surgery
    Time Frame
    up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unilateral complete cleft lip patients Alveolar bone cleft diagnosed with conventional radiographic study Patients at the stage of mixed dentition. Informed consent signed by the parents or custodians. Exclusion Criteria: Presentation of other craniofacial anomalies. Parents or custodians who do not agreed to this procedure.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philip Kuo-Ting Chen, M.D.
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7041248
    Citation
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    Bajaj AK, Wongworawat AA, Punjabi A. Management of alveolar clefts. J Craniofac Surg. 2003 Nov;14(6):840-6. doi: 10.1097/00001665-200311000-00005.
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    Alveolar Bone Grafting Outcome Between Patient With and Without Orthodontic Treatment

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