NCT02454998

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

February 1, 2015

Enrollment Period

4.4 years

First QC Date

February 17, 2015

Last Update Submit

May 26, 2015

Conditions

Cleft Lip

Keywords

Unilateral complete cleft lipAlveolar bone graft

Outcome Measures

Primary Outcomes (3)

  • Pre-orthodontic alveolar bone defect

    CT scan, measurement of alveolar bone cleft defect volume

    Before surgical and orthodontic treatment, A expected average of 6 months before surgery

  • Pre-surgical alveolar bone defect

    CT scan, measurement of alveolar bone cleft defect volume

    Before surgical treatment (alveolar bone cleft), a expected average of 6 months of orthodontic treatment

  • Alveolar bone graft survival

    CT scan, measurement of volume of bone graft filling the alveolar bone cleft

    A expected average of 6 months after surgery

Secondary Outcomes (1)

  • Infection rate

    up to 6 months

Study Arms (2)

Orthodontic treatment arm

EXPERIMENTAL

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

Other: orthodontic treatment

No orthodontic treatment arm

NO INTERVENTION

No orthodontic treatment previous to surgical alveolar bone grafting

Interventions

orthodontic treatmentOTHER

Braces on the upper dental arch previous to surgical alveolar bone grafting. the goal is optimizing the structure of dental-alveolar structure.

Orthodontic treatment arm

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Abyholm FE, Bergland O, Semb G. Secondary bone grafting of alveolar clefts. A surgical/orthodontic treatment enabling a non-prosthodontic rehabilitation in cleft lip and palate patients. Scand J Plast Reconstr Surg. 1981;15(2):127-40. doi: 10.3109/02844318109103425. No abstract available.

    PMID: 7041248BACKGROUND

  • Boyne PJ, Sands NR. Secondary bone grafting of residual alveolar and palatal clefts. J Oral Surg. 1972 Feb;30(2):87-92. No abstract available.

    PMID: 4550446BACKGROUND

  • 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.

    PMID: 14600625BACKGROUND

  • da Silva Filho OG, Boiani E, de Oliveira Cavassan A, Santamaria M Jr. Rapid maxillary expansion after secondary alveolar bone grafting in patients with alveolar cleft. Cleft Palate Craniofac J. 2009 May;46(3):331-8. doi: 10.1597/07-205.1. Epub 2008 Oct 29.

    PMID: 19642749BACKGROUND

  • Sato Y, Grayson BH, Garfinkle JS, Barillas I, Maki K, Cutting CB. Success rate of gingivoperiosteoplasty with and without secondary bone grafts compared with secondary alveolar bone grafts alone. Plast Reconstr Surg. 2008 Apr;121(4):1356-1367. doi: 10.1097/01.prs.0000302461.56820.c9.

    PMID: 18349656BACKGROUND

  • Hsieh CH, Ko EW, Chen PK, Huang CS. The effect of gingivoperiosteoplasty on facial growth in patients with complete unilateral cleft lip and palate. Cleft Palate Craniofac J. 2010 Sep;47(5):439-46. doi: 10.1597/08-207.

    PMID: 20180706BACKGROUND

  • Witherow H, Cox S, Jones E, Carr R, Waterhouse N. A new scale to assess radiographic success of secondary alveolar bone grafts. Cleft Palate Craniofac J. 2002 May;39(3):255-60. doi: 10.1597/1545-1569_2002_039_0255_anstar_2.0.co_2.

    PMID: 12019000BACKGROUND

  • Bergland O, Semb G, Abyholm FE. Elimination of the residual alveolar cleft by secondary bone grafting and subsequent orthodontic treatment. Cleft Palate J. 1986 Jul;23(3):175-205.

    PMID: 3524905BACKGROUND

  • Jia YL, Fu MK, Ma L. Long-term outcome of secondary alveolar bone grafting in patients with various types of cleft. Br J Oral Maxillofac Surg. 2006 Aug;44(4):308-12. doi: 10.1016/j.bjoms.2005.07.003. Epub 2005 Aug 16.

    PMID: 16107298BACKGROUND

  • Craven C, Cole P, Hollier L Jr, Stal S. Ensuring success in alveolar bone grafting: a three-dimensional approach. J Craniofac Surg. 2007 Jul;18(4):855-9. doi: 10.1097/scs.0b013e31806849fa.

    PMID: 17667677BACKGROUND

  • Enemark H, Sindet-Pedersen S, Bundgaard M. Long-term results after secondary bone grafting of alveolar clefts. J Oral Maxillofac Surg. 1987 Nov;45(11):913-9. doi: 10.1016/0278-2391(87)90439-3.

    PMID: 3312537BACKGROUND

  • Sindet-Pedersen S, Enemark H. Comparative study of secondary and late secondary bone-grafting in patients with residual cleft defects. Short-term evaluation. Int J Oral Surg. 1985 Oct;14(5):389-98. doi: 10.1016/s0300-9785(85)80071-5.

    PMID: 3932232BACKGROUND

  • Honma K, Kobayashi T, Nakajima T, Hayasi T. Computed tomographic evaluation of bone formation after secondary bone grafting of alveolar clefts. J Oral Maxillofac Surg. 1999 Oct;57(10):1209-13. doi: 10.1016/s0278-2391(99)90488-3.

    PMID: 10513867BACKGROUND

  • Tai CC, Sutherland IS, McFadden L. Prospective analysis of secondary alveolar bone grafting using computed tomography. J Oral Maxillofac Surg. 2000 Nov;58(11):1241-9; discussion 1250. doi: 10.1053/joms.2000.16623.

    PMID: 11078135BACKGROUND

  • Hamada Y, Kondoh T, Noguchi K, Iino M, Isono H, Ishii H, Mishima A, Kobayashi K, Seto K. Application of limited cone beam computed tomography to clinical assessment of alveolar bone grafting: a preliminary report. Cleft Palate Craniofac J. 2005 Mar;42(2):128-37. doi: 10.1597/03-035.1.

    PMID: 15748103BACKGROUND

  • Waitzman AA, Posnick JC, Armstrong DC, Pron GE. Craniofacial skeletal measurements based on computed tomography: Part I. Accuracy and reproducibility. Cleft Palate Craniofac J. 1992 Mar;29(2):112-7. doi: 10.1597/1545-1569_1992_029_0112_csmboc_2.3.co_2.

    PMID: 1571344BACKGROUND

  • Goudy S, Lott D, Burton R, Wheeler J, Canady J. Secondary alveolar bone grafting: outcomes, revisions, and new applications. Cleft Palate Craniofac J. 2009 Nov;46(6):610-2. doi: 10.1597/08-126.1. Epub 2009 May 19.

    PMID: 19860505BACKGROUND

MeSH Terms

Conditions

Cleft Lip

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Philip Kuo-Ting Chen, M.D.

    Chang Gung Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

May 27, 2015

Study Start

February 1, 2011

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-02