Partial Maxillary Expansion With Post Grafting Expansion vs. Pre Full Maxillary Expansion in Secondary Alveolar Cleft
The Effect of Pre Grafting Partial Maxillary Expansion With Post Grafting Expansion Versus Pre Grafting Full Maxillary Expansion on the Stability and Bone Resorption in Secondary Unilateral Alveolar Cleft Grafting
1 other identifier
interventional
20
1 country
1
Brief Summary
Intermediate grafting with both pre- and post- grafting maxillary expansion with time span after grafting 6-8 weeks for consolidation and final retention for 3 months after finalization of expansion will get the advantages of both techniques combined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2023
CompletedFirst Submitted
Initial submission to the registry
June 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2025
CompletedMay 30, 2025
May 1, 2025
2.2 years
June 11, 2023
May 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Bone volume change
bone volume is measured to ensure successful grafting
6 months
Secondary Outcomes (1)
presence of relapse of expansion
8 months
Study Arms (2)
pre grafting partial maxillary expansion with post grafting expansion
EXPERIMENTALpregrafting partial maxillary expansion then grafting left bone to consolidate for 2 months followed by post grafting expansion till full arch alignment
pre grafting full maxillary expansion
ACTIVE COMPARATORpre grafting full maxillary expansion till full arch alignment then grafting and let bone to consolidate
Interventions
pre grafting partial maxillary expansion then anterior iliac grafting followed by 2 months period for consolidation then post grafting expansion till full arch alignment
Eligibility Criteria
You may qualify if:
- Patients with unilateral cleft alveolus with in the mixed dentition stage No intraoral soft and hard tissue pathology No systemic condition that contraindicate grafting
You may not qualify if:
- Local criteria:
- poor oral hygiene
- radiation therapy the head and neck cancers
- Systemic criteria:
- immunity deficiency or hemorrhagic inherited diseases
- Bone pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry Cairo University
Cairo, Egypt
Related Publications (2)
Uzel A, Benlidayi ME, Kurkcu M, Kesiktas E. The Effects of Maxillary Expansion on Late Alveolar Bone Grafting in Patients With Unilateral Cleft Lip and Palate. J Oral Maxillofac Surg. 2019 Mar;77(3):607-614. doi: 10.1016/j.joms.2018.07.022. Epub 2018 Jul 27.
PMID: 30138625BACKGROUNDKaura AS, Srinivasa DR, Kasten SJ. Optimal Timing of Alveolar Cleft Bone Grafting for Maxillary Clefts in the Cleft Palate Population. J Craniofac Surg. 2018 Sep;29(6):1551-1557. doi: 10.1097/SCS.0000000000004680.
PMID: 29916970BACKGROUND
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
June 11, 2023
First Posted
July 12, 2023
Study Start
February 20, 2023
Primary Completion
April 20, 2025
Study Completion
April 20, 2025
Last Updated
May 30, 2025
Record last verified: 2025-05