Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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