Actively Recruiting

Phase Not Applicable
Age: 20Years - 48Years
All Genders
ID06746935

Reconstruction of Deficient Atrophic Ridges Using Guided Bone Regeneration Technique With Native Collagen Membrane and Polytetrafluoroethylene Membrane (Randomized Clinical Trial)

Led by Cairo University · Updated on 2025-02-19

20

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates two bone regeneration techniques for patients needing ridge augmentation or bone augmentation in the upper jaw. It compares a mixture of autogenous and xenogenic bone covered either by a polytetrafluoroethylene (PTFE) membrane or a native collagen membrane. Patients are randomly assigned to one of these two groups to study the effectiveness of these membranes in bone healing after ridge augmentation. Both groups undergo similar surgical procedures involving local anesthesia, creation of a mucoperiosteal flap, harvesting autogenous bone using an auto chip maker, and mixing it with xenogenic bone in a 1:1 ratio. This bone mixture is placed in the recipient site and fixed with titanium bone tacks. The control group’s bone assembly is covered with a PTFE membrane, while the study group’s assembly is covered with a resorbable collagen membrane. After surgery, the flap is closed carefully to ensure tension-free healing. Participants have diagnostic CBCT scans for the upper arch before surgery and again four months after the procedure to measure bone gain. They receive diagnostic wax-up and stent fabrication as part of the preparation. Researchers monitor soft tissue healing starting one week after surgery, noting any wound dehiscence. The main outcome measured is the quantity of bone gained after four months. The entire study period spans from initial screening through four months of follow-up.

CONDITIONS

Brief Title

Reconstruction of Deficient Atrophic Ridges Using Guide Bone Regeneration Technique

Who Can Participate

Age: 20Years - 48Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with maxillary residual alveolar bone height not less than 8 mm
  • Alveolar bone width less than or equal to 5 mm
  • Both sexes
  • At least one missing tooth
  • Previous failed implants
  • Previous failed grafting
Not Eligible

You will not qualify if you...

  • Heavy smokers who smoke more than 20 cigarettes per day
  • Patients with bone diseases affecting normal healing, such as hyperparathyroidism
  • Patients who had radiotherapy or chemotherapy in the head and neck region
  • Patients with neoplasms in sites to be grafted
  • Patients with uncontrolled metabolic diseases, including diabetes with glycated hemoglobin (Hb A1c) over 7 mg/dl

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo guided bone regeneration surgery with a particulate bone mixture covered by either a native collagen membrane or polytetrafluoroethylene membrane, followed by immediate post-operative care including flap preparation, bone grafting, and wound closure.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 4 months

Participants are monitored for soft tissue healing and possible complications such as soft tissue dehiscence starting from the first week after surgery.

Approximately weekly visits during the first month, then periodic visits up to 4 months

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry Cairo University

Cairo, Egypt, 11553

Actively Recruiting

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Research Team

M

Mohannad A. Ismail, MSc.

Z

Zeyad adel Mostafa., MSc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Titanium Mesh Technique in Rehabilitation of Totally Edentulous Atrophic Maxillae: A Retrospective Case Series.

Gerardo Pellegrino, Giuseppe Lizio, Giuseppe Corinaldesi...

https://pubmed.ncbi.nlm.nih.gov/26759078

Autogenous mandibular bone grafts and osseointegrated implants for reconstruction of the severely atrophied maxilla: a preliminary report.

J Jensen, S Sindet-Pedersen

https://pubmed.ncbi.nlm.nih.gov/1955919

Ramus or chin grafts for maxillary sinus inlay and local onlay augmentation: comparison of donor site morbidity and complications.

Jaime Clavero, Stefan Lundgren

https://pubmed.ncbi.nlm.nih.gov/14575631

Clinical, histological and histomorphometric evaluation of the healing of mandibular ramus bone block grafts for alveolar ridge augmentation before implant placement.

Alessandro Acocella, Roberto Bertolai, Maurizio Colafranceschi...

https://pubmed.ncbi.nlm.nih.gov/19648020