Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique

NCT06523855 | Not Yet Recruiting

• 1 other identifier: 4623358
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.

Conditions

Alveolar Cleft

Keywords

alveolar cleft; iliac crest grafting; microplate; bone resorption; oronasal fistula

Outcome Measures

Primary Outcomes (1)

• Bone density immediate versus 6 months postoperatively.

  bone density changes are measured using CBCT after 6 months via HU

  6 months

Secondary Outcomes (1)

• Bone width and height immediate versus 6 months postoperatively

  6 months

Study Arms (2)

bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

EXPERIMENTAL

in bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect, 8-hole microplates will be used to fix the premaxilla using screws. The microplates are to be removed 6 to 9 months postoperatively.

Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

bilateral alveolar cleft grafting using iliac crest particulate

ACTIVE COMPARATOR

in bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect.

Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

Interventions

bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation PROCEDURE

bilateral alveolar cleft grafting using particulate iliac crest graft accompanied with fixation of graft and premaxilla using microplate

bilateral alveolar cleft grafting using iliac crest particulate; bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old).
• repaired cleft lip.
• Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
• Both genders males and females will be included.

You may not qualify if:

• General contraindications to surgical intervention of the area.
• Patients with unilateral maxillary alveolar cleft.
• Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft
• Subjected to irradiation in the head and neck area less than 1 year before surgery.
• Untreated periodontitis.
• Poor oral hygiene.
• Uncontrolled diabetes.
• Immunosuppressed or immunocompromised.
• Active infection or severe inflammation in the area intended for graft placement
• Unable to open mouth sufficiently to accommodate the surgical tooling.
• Patients participating in other studies, if the present protocol could not be properly followed.
• Unable to attend a 9-month follow-up.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo university

Cairo, 12311, Egypt

Location

Related Publications (5)

• Smarius B, Loozen C, Manten W, Bekker M, Pistorius L, Breugem C. Accurate diagnosis of prenatal cleft lip/palate by understanding the embryology. World J Methodol. 2017 Sep 26;7(3):93-100. doi: 10.5662/wjm.v7.i3.93. eCollection 2017 Sep 26.

  PMID: 29026689 BACKGROUND

• Seifeldin SA. Is alveolar cleft reconstruction still controversial? (Review of literature). Saudi Dent J. 2016 Jan;28(1):3-11. doi: 10.1016/j.sdentj.2015.01.006. Epub 2015 Jun 25.

  PMID: 26792963 BACKGROUND

• Mahardawi B, Boonsiriseth K, Pairuchvej V, Wongsirichat N. Alveolar cleft bone grafting: factors affecting case prognosis. J Korean Assoc Oral Maxillofac Surg. 2020 Dec 31;46(6):409-416. doi: 10.5125/jkaoms.2020.46.6.409.

  PMID: 33377466 BACKGROUND

• 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: 4550446 BACKGROUND

• Chen S, Liu B, Liu J, Yin N, Wang Y. Comparison of Three-Dimensional Printing and Computer-aided Engineering in Presurgical Volumetric Assessment of Bilateral Alveolar Clefts. J Craniofac Surg. 2020 Mar/Apr;31(2):412-415. doi: 10.1097/SCS.0000000000006011.

  PMID: 31764559 BACKGROUND

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Sameh Mekhemer, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Maha Ibrahim, bachelor of dentistry

CONTACT

01116003653; maha.ahmed@dentistry.cu.edu.eg

Alaa Hassan, MSc

CONTACT

01090101125; alaa.hassan@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at oral and maxillofacial surgery department

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 26, 2024
• Study Start: July 24, 2024
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)