Cleft Orthognathic Surgery Versus Distraction Osteogenesis - Which is Better?

NCT00930124 | Completed Phase 2

• 1 other identifier: CLP_DOvsCO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cleft lip and palate patients normally present with a sunken face due to collapse in the middle part of the face and inability of the upper and lower teeth to meet during chewing. This situation constitutes a serious aesthetic and mastication problem. A single surgical operation known as orthognathic surgery was traditionally performed to move the upper jaw forward to a more normal position and allow chewing function to be regained. However, due to scar tissue from the original surgical repair of the cleft palate, this procedure is known to be unstable causing bone to rapidly go back to its original position. A new concept of moving the upper jaw bone gradually by 1mm per day using a special device attached to the bone called distraction osteogenesis was established in 1996. Animal studies have shown that this technique can produce stable results with minimal relapse. The feasibility of correcting cleft deformities by gradual distraction has been confirmed by our own clinical studies. The aim of this study (which is the first of its kind) is to conduct a prospective randomized controlled study and compare the treatment outcomes of the current standard (orthognathic surgery) with distraction osteogenesis (gradual bone movement). The objectives focus on four aspects: morbidity, stability, speech function and psychological impact. The results from this study will clarify several clinical dilemmas in decision making when choosing whether to use orthognathic surgery or distraction osteogenesis in the treatment of cleft lip and palate patients. In addition, it will also inform our multidisciplinary research team to improve the total care of the cleft lip and palate patients. Gradual bone distraction of the midface in cleft palate patients is more stable, less detrimental to speech, and no more troublesome to the patient than conventional osteotomy and bone transposition (orthognathic surgery).

Conditions

Cleft Lip and Palate; Maxillary Hypoplasia

Keywords

cleft lip and palate; distraction osteogenesis; conventional orthognathic surgery; stability; morbidity; soft tissue changes; psychological adjustment; speech changes; velopharyngeal function

Outcome Measures

Primary Outcomes (1)

• standardized questionnaires, lateral cephalographs,nasoendoscopy, nasometry

  intra-operative and post-operatively at 2-6 weeks, 2,3,6,months, 1, 2, 3, 4, 5 years

Study Arms (2)

1

EXPERIMENTAL

Group 1 will receive Conventional orthognathic surgery

Procedure: Orthognathic surgery

2

ACTIVE COMPARATOR

Group 2 will receive distraction osteogenesis

Procedure: Distraction osteogenesis

Interventions

Orthognathic surgery PROCEDURE

Patients with moderate maxillary hypoplasia needing an advancement of 4-10mm

Also known as: cleft osteotomy

1

Distraction osteogenesis PROCEDURE

Also known as: cleft distraction

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cleft lip and palate patients who required maxillary advancement ranging from 4-10 mm

You may not qualify if:

• syndromic cases, skeletal maturity not yet reached

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

OMFS, Faculty of Dentistry, The University of Hong Kong

Sai Ying Pun, Hong Kong

Location

MeSH Terms

Conditions

Cleft Lip; Retrognathia

Interventions

Orthognathic Surgery; Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry; Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Lim K Cheung, BDS, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: June 30, 2009
• Study Start: June 1, 2002
• Primary Completion: October 1, 2004
• Study Completion: January 1, 2008
• Last Updated: September 13, 2011

Record last verified: 2011-09

Locations

HK (1)