Reconstruction of Deficient Maxillary Ridges Using Retromolar Blocks With and Without Collagen Membrane
Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Retromolar Blocks With and Without Coverage Using Collagen Membrane (Randomized Clinical Trials)
1 other identifier
interventional
30
1 country
1
Brief Summary
Is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in Maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quantity?
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 May 2025
Shorter than P25 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
First Submitted
Initial submission to the registry
March 21, 2025
CompletedFirst Posted
Study publicly available on registry
March 28, 2025
CompletedStudy Start
First participant enrolled
May 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2026
CompletedJuly 16, 2025
July 1, 2025
6 months
March 21, 2025
July 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Quantity of bone gain.
Measured using linear measurements from Cone Beam Computed Tomography in millimeters.
At 5 months from ridge augmentation.
Secondary Outcomes (1)
Soft Tissue Dehiscence
Baseline 1st Week. Written Binary Numerical Yes or No.
Study Arms (2)
Study Group A: Retromolar bone block covered with collagen membrane.
EXPERIMENTALThe onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site. The assembly is going to be covered with native collagen membrane and fixed with titanium bone tacks.
Control Group B: Retromolar bone block without collagen membrane.
ACTIVE COMPARATORThe onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site.
Interventions
Onlay bone block covered with collagen membrane
Onlay bone block covered without collagen membrane
Eligibility Criteria
You may qualify if:
- Patients with maxillary residual alveolar bone height not less than 8 mm.
- Alveolar bone width from less than or equal 5 mm.
- Both genders.
- At least missing single tooth.
- Previous Failed Implants.
- Previous Failed Grafting.
You may not qualify if:
- Heavy smokers more than 20 cigarettes per day.
- Patients with alcohol abuse
- Patients with narcotic abuse.
- Patients with bone disease that may affect normal healing, example; hyperparathyroidism.
- Patients had radiotherapy and chemotherapy in head and neck.
- Patients had neoplasms in sites to be grafted.
- Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\\dl.
- Pregnant females.
- Patients with Para functional habits, apprehensive and non-cooperative.
- Bone pathology related to the site to be grafted.
- Psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations.
- Intraoral soft and hard tissue pathology.
- Systemic condition that contraindicate implant placement.
- Under the age of 18 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry Cairo University
Cairo, 11553, Egypt
Related Publications (8)
Hammerle CH, Jung RE. Bone augmentation by means of barrier membranes. Periodontol 2000. 2003;33:36-53. doi: 10.1046/j.0906-6713.2003.03304.x. No abstract available.
PMID: 12950840BACKGROUNDCash and Alex: 20 years of guided bone regeneration in implant dentistry, 2nd ed. (2009).
BACKGROUNDUrban, I A., Nagrusky H, Lozada JM:
BACKGROUNDUrban, I A., Nagrusky H, Lozada JM.:
BACKGROUNDPellegrino G, Lizio G, Corinaldesi G, Marchetti C. Titanium Mesh Technique in Rehabilitation of Totally Edentulous Atrophic Maxillae: A Retrospective Case Series. J Periodontol. 2016 May;87(5):519-28. doi: 10.1902/jop.2016.150432. Epub 2016 Jan 12.
PMID: 26759078BACKGROUNDPolis-Yanes C, Cadenas-Sebastian C, Gual-Vaques P, Ayuso-Montero R, Mari-Roig A, Lopez-Lopez J. Guided Bone Regeneration of an Atrophic Maxilla Using Heterologous Cortical Lamina. Case Rep Dent. 2019 Jun 11;2019:5216362. doi: 10.1155/2019/5216362. eCollection 2019.
PMID: 31308978BACKGROUNDJensen J, Sindet-Pedersen S. Autogenous mandibular bone grafts and osseointegrated implants for reconstruction of the severely atrophied maxilla: a preliminary report. J Oral Maxillofac Surg. 1991 Dec;49(12):1277-87. doi: 10.1016/0278-2391(91)90303-4.
PMID: 1955919BACKGROUNDMontazem A, Valauri DV, St-Hilaire H, Buchbinder D. The mandibular symphysis as a donor site in maxillofacial bone grafting: a quantitative anatomic study. J Oral Maxillofac Surg. 2000 Dec;58(12):1368-71. doi: 10.1053/joms.2000.18268.
PMID: 11117684BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
March 21, 2025
First Posted
March 28, 2025
Study Start
May 28, 2025
Primary Completion
November 15, 2025
Study Completion
February 15, 2026
Last Updated
July 16, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share