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)

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?

Study Overview

• Status: Recruiting
• Conditions: Bone Augmentation
• Intervention / Treatment: Procedure: Onlay bone block covered with collagen membrane; Procedure: Onlay bone block without collagen membrane

Detailed Description

Soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. Any attempt of bone recontouring and resuturing fails since there is no vascular bed. Ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. Space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. Some types of collagen membrane, contain some degrees of stretchability example Geistlich Bio-Gide or Jason Membrane Botiss.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohannad A. Ismail, MSc.; Phone Number: +20 01222968444; Email: mohannadahmed@hotmail.com
• Study Contact Backup: Name: Niveen A. Askar, PhD; Phone Number: +20 01001558769; Email: niveen.askar@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Recruiting
    • Faculty of Dentistry Cairo University
    • Contact: Niveen A. Askar, Professor; Phone Number: +20 +201001558769; Email: niveen.askar@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group A: Retromolar bone block covered with collagen membrane.; The 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.	Procedure: Onlay bone block covered with collagen membrane; Onlay bone block covered with collagen membrane
Active Comparator: Control Group B: Retromolar bone block without collagen membrane.; The 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.	Procedure: Onlay bone block without collagen membrane; Onlay bone block covered without collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of bone gain.	Measured using linear measurements from Cone Beam Computed Tomography in millimeters.	At 5 months from ridge augmentation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft Tissue Dehiscence	Exposure of bone block assembly and impaired healing	Baseline 1st Week. Written Binary Numerical Yes or No.

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• Cash and Alex: 20 years of guided bone regeneration in implant dentistry, 2nd ed. (2009).
• Pellegrino 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.
• Polis-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.
• Jensen 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.
• Montazem 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.
• Urban, I A., Nagrusky H, Lozada JM:
• Urban, I A., Nagrusky H, Lozada JM.:

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2025
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 22, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 12, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0-0002-9582-5106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No