Reconstruction of Deficient Maxillary Ridges Using Retromolar Blocks With and Without Collagen Membrane

NCT ID: NCT06900933

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2026-02-15

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?

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.

Conditions

Bone Augmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Onlay bone block covered with collagen membrane

Intervention Type: PROCEDURE

Onlay bone block covered with collagen membrane

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.

Group Type: ACTIVE_COMPARATOR

Onlay bone block without collagen membrane

Intervention Type: PROCEDURE

Onlay bone block covered without collagen membrane

Interventions

Onlay bone block covered with collagen membrane

Onlay bone block covered with collagen membrane

Intervention Type: PROCEDURE

Onlay bone block without collagen membrane

Onlay bone block covered without collagen membrane

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohannad Ahmed Ismail

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohannad A. Ismail, MSc.

Role: CONTACT

mohannadahmed@hotmail.com

01222968444 ext. +20

Niveen A. Askar, PhD

Role: CONTACT

niveen.askar@dentistry.cu.edu.eg

01001558769 ext. +20

Facility Contacts

Niveen A. Askar, Professor

Role: primary

niveen.askar@dentistry.cu.edu.eg

+201001558769 ext. +20

References

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.

Reference Type: BACKGROUND

PMID: 12950840 (View on PubMed)

Cash and Alex: 20 years of guided bone regeneration in implant dentistry, 2nd ed. (2009).

Reference Type: BACKGROUND

Urban, I A., Nagrusky H, Lozada JM:

Reference Type: BACKGROUND

Urban, I A., Nagrusky H, Lozada JM.:

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 26759078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31308978 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1955919 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11117684 (View on PubMed)

Other Identifiers

0-0002-9582-5106

Identifier Type: -

Identifier Source: org_study_id