Bone-borne Palatal Expander With Corticotomy for Cleft Palate Patients

NCT03837652 | Unknown DMC

• 1 other identifier: SarahSamehMsc
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The tooth-borne palatal expander has limitations in the subset of patients with scarred, constricted cleft palate. At times, although posterior expansion is successful, transverse expansion of the anterior palate (near the alveolar cleft) is inadequate. Will the application of bone borne palatal expander combined with a corticotomy be more effective in the expansion of the constricted maxilla in cleft palate patients?

Conditions

Cleft Palate

Keywords

Cleft palate; transverse discrepancy; palatal expansion; bone-borne

Outcome Measures

Primary Outcomes (1)

• Adequate maxillary expansion

  Dental casts before treatment \& immediately after completion of expansion to determine transverse changes in maxillary arch width measured in millimeter at the following sites: Intermolar width Intercanine width Interarch width 6 CBCT before operation \& immediately after completion of consolidation period (10 weeks). Distances measured on the coronal images in millimeters before treatment \& after the end of the consolidation period: NFW4 \& NFW6: Nasal floor width at the area of first premolars \& first molars, 5mm above the most inferior part of nasal floor PBW4 \& PBW6 : Palatal bone width at the level of a line connecting palatal root apex of first premolars \& first molars IRD4: distance between palatal root apex of right \& left first premolars IRD6: distance between palatal root apex of right \& left first molars

  10-12 weeks post operatively

Interventions

Use of bone-borne palatal expander & maxillary osteotomy OTHER

Application of bone-borne palatal expander in conjunction with maxillary osteotomy for expansion of constricted maxillae

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with non-syndromic cleft palate.
• Patients with constricted maxilla after surgical treatment of cleft palate.
• Patients failed orthodontic expansion.
• Patients age between 8 and 18 years.

You may not qualify if:

• Patients with systemic disease or bleeding disorders.
• Patients with syndromic cleft palate.
• Patients failed with tooth borne expansion.
• Patients with fistula in cleft palate

Sponsors & Collaborators

• Sarah Ahmed Sameh: lead
• Cairo University: collaborator

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (7)

• Figueiredo DS, Cardinal L, Bartolomeo FU, Palomo JM, Horta MC, Andrade I Jr, Oliveira DD. Effects of rapid maxillary expansion in cleft patients resulting from the use of two different expanders. Dental Press J Orthod. 2016 Nov-Dec;21(6):82-90. doi: 10.1590/2177-6709.2016-001.aop.

  PMID: 27683832 BACKGROUND

• Marazita ML, Mooney MP. Current concepts in the embryology and genetics of cleft lip and cleft palate. Clin Plast Surg. 2004 Apr;31(2):125-40. doi: 10.1016/S0094-1298(03)00138-X.

  PMID: 15145658 BACKGROUND

• Aziz SR, Tanchyk A. Surgically assisted palatal expansion with a bone-borne self-retaining palatal expander. J Oral Maxillofac Surg. 2008 Sep;66(9):1788-93. doi: 10.1016/j.joms.2008.04.017.

  PMID: 18718384 BACKGROUND

• Gunaseelan R, Cheung LK, Krishnaswamy R, Veerabahu M. Anterior maxillary distraction by tooth-borne palatal distractor. J Oral Maxillofac Surg. 2007 May;65(5):1044-9. doi: 10.1016/j.joms.2005.12.049. No abstract available.

  PMID: 17448861 BACKGROUND

• Zandi M, Miresmaeili A, Heidari A. Short-term skeletal and dental changes following bone-borne versus tooth-borne surgically assisted rapid maxillary expansion: a randomized clinical trial study. J Craniomaxillofac Surg. 2014 Oct;42(7):1190-5. doi: 10.1016/j.jcms.2014.02.007. Epub 2014 Feb 22.

  PMID: 24704281 BACKGROUND

• Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.

  PMID: 25490552 BACKGROUND

• Abouseada SAS, El-Ghafour MA, Kamel HM, Elbokle NN. Evaluation of transpalatal distraction in cleft palate patients. Oral Maxillofac Surg. 2024 Jun;28(2):967-974. doi: 10.1007/s10006-024-01207-4. Epub 2024 Jan 22.

  PMID: 38253979 DERIVED

MeSH Terms

Conditions

Cleft Palate

Interventions

Maxillary Osteotomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orthognathic Surgical Procedures; Oral Surgical Procedures; Dentistry

Study Officials

• Sarah Sameh, BDS

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Sameh, BDS

CONTACT

01001445232; sarahahmed35@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Before and after Study

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 12, 2019
• Study Start: February 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

EG (1)