Actively Recruiting
Evaluation of Endosseous Implants in One Stage Ridge Splitting Using the Conventional Technique Versus Piezo Surgery in the Maxilla
Led by Cairo University · Updated on 2025-07-16
20
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two techniques for ridge splitting in the upper jaw (maxilla) to support dental implants. The study compares a conventional method using bone discs with an approach using piezo surgery, aiming to assess bone gain quality and healing outcomes in patients with specific bone conditions and missing teeth. This is an interventional trial sponsored by Cairo University involving adults aged 20 to 48 years. Both groups undergo similar surgical steps including local anesthesia, flap creation, bone exposure, and implant placement below the bone crest. The study group receives piezo surgery bone inserts to cut the crestal osteotomy, while the control group uses bone discs mounted on handpieces for the same purpose. Additional procedures include bone chiseling, implant drilling, bone smoothing, and placement of xenogenic bone particles into the surgical site. Closure is performed with a double line suture technique to ensure tension-free healing. Participants will have cone beam computed tomography (CBCT) scans before and four months after surgery to evaluate bone gain. Other assessments include evaluation of soft tissue healing one week after surgery. The study involves randomized allocation to one of the two surgical techniques with single blinding. Monitoring includes clinical evaluations of bone and soft tissue, with the primary outcome measured four months after ridge augmentation, and a total participation duration covering preoperative assessment through postoperative follow-up.
CONDITIONS
Brief Title
One Stage Ridge Splitting Using 2 Different Techniques in Maxilla
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with maxilla residual alveolar bone height not less than 8 mm
- Alveolar bone width from 3 mm to 5 mm
- Both genders
- At least single missing tooth
- Previous failed implants
- Tapered or cylinder cross sectioned alveolar bone defect pattern
You will not qualify if you...
- Heavy smokers more than 20 cigarettes per day
- Patients with bone diseases affecting healing, such as hyperparathyroidism
- Patients who had radiotherapy or chemotherapy in head and neck
- Patients with neoplasms in graft sites
- Patients with uncontrolled metabolic diseases, including diabetes with HbA1c over 7 mg/dl
- Pregnant females
- Patients with parafunctional habits or who are apprehensive and non-cooperative
- Bone pathology related to graft site
- Psychological problems, social or professional stress, emotional instability, or unrealistic expectations
- Intraoral soft and hard tissue pathology
- Systemic conditions contraindicating implant placement
- Under 18 years of age
- Hourglass defects or defects with bone concavities or undercuts in the graft site
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
Participants undergo one-stage ridge splitting surgery using either the conventional technique with bone discs or piezo surgery. Local anesthesia is administered, and implants are placed followed by bone grafting and wound closure.
1 surgical visit (in-person)
Duration - 4 months
Participants receive follow-up care including CBCT imaging and assessment of bone quality and soft tissue healing after surgery.
1 follow-up visit at 4 months post-surgery
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry Cairo University
Cairo, Egypt, 11553
Actively Recruiting
Research Team
M
Mohannad A. Ismail, MSc.
A
Ahmed M Youssef, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2