Actively Recruiting
Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Retromolar Blocks With and Without Coverage Using Collagen Membrane (Randomized Clinical Trials)
Led by Cairo University · Updated on 2025-07-16
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether using a collagen membrane on top of a particulate bone mixture covered by an onlay bone block in the maxilla improves bone quantity compared to using the mixture and bone block without the collagen membrane. The study aims to address complications like soft tissue dehiscence that can affect bone stability and integration. It also examines barrier membranes' ideal qualities, such as biocompatibility, nutrient diffusion, and tissue integration, using collagen membranes like Geistlich Bio-Gide or Jason Membrane Botiss. Participants receive treatment involving onlay bone blocks harvested from the retromolar region, fixed with micro screws. In the experimental group, the bone block and particulate bone mixture are covered with a native collagen membrane fixed with titanium bone tacks. The control group receives the same bone block and particulate bone mixture without collagen membrane coverage. This randomized clinical trial compares these two procedures to evaluate bone gain. During the study, participants are monitored for bone quantity gain at 5 months after ridge augmentation, which is the primary outcome measure. Researchers also assess soft tissue dehiscence at baseline and one week after treatment. The study includes assessments of bone stability and soft tissue healing. Participants aged 20 to 40 years with specified maxillary bone conditions are involved, with follow-up evaluations to measure outcomes and safety.
CONDITIONS
Brief Title
Reconstruction of Deficient Maxillary Ridges Using Retromolar Blocks With and Without Collagen Membrane
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 genders
- At least one missing tooth
- Previous failed implants
- Previous failed grafting
You will not qualify if you...
- Heavy smokers more than 20 cigarettes per day
- Patients with alcohol abuse
- Patients with narcotic abuse
- Patients with bone diseases that may affect normal healing, such as hyperparathyroidism
- Patients who had radiotherapy or chemotherapy in head and neck
- Patients with neoplasms in sites to be grafted
- Patients with uncontrolled metabolic diseases, such as diabetes with HbA1c greater than 7 mg/dl
- Pregnant females
- Patients with parafunctional habits, apprehensive or non-cooperative behavior
- Bone pathology related to the graft site
- Psychological problems, emotional instability, or unrealistic expectations
- Intraoral soft and hard tissue pathology
- Systemic conditions contraindicating implant placement
- Under 18 years of age
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.
Duration - Single day for surgery and initial recovery period
Participants undergo bone reconstruction surgery where a retromolar onlay bone block is placed with or without a collagen membrane to rebuild deficient maxillary ridges.
1 surgery visit (in-person) and immediate post-operative care visits
Duration - Approximately 5 months
Participants are monitored for healing, complications such as soft tissue dehiscence, and integration of the bone graft over several months.
Multiple follow-up visits during the first week and periodic visits up to 5 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.
N
Niveen A. Askar, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2