NCT06746935 Reconstruction of Deficient Atrophic Ridges Using Guide Bone Regeneration Technique
| NCT ID | NCT06746935 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Ridge Augmentation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-01-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
patients will be informed of the nature of the research work and informed consent will be obtained then randomized in 2 groups. Mixture 1:1 autogenous and xenogenic bone covered with Polytetrafluoroethylene membrane control group and study group p covered with native collagen membrane. * Patients of both groups will be subjected to CBCT (diagnostic for upper arch), diagnostic wax-up and stent fabrication. * Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months. Both the study and control group will receive: * In Recipient site, using 15C blade on Bard Parker handle incision of full thickness mucoperiosteal flap inorder to obtain, three-line pyramidal flap, reflection using mucoperiosteal elevator molt 9. * The defective site is reevaluated after its primary evaluation on CBCT using UNC (University of North Carolina) periodontal probe and a template is cut using sterile suture pack, prior to donor site preparation. * Flap advancement using periosteal releasing incision inorder to allow later tension free flap closure. * In Donor site, mucoperiosteal flap is done, auto chip maker (ACM) is used for autogenous bone harvesting. * Autogenous particulate bone graft is obtained using auto chip maker bur (ACM), in implant contra 20:1 using surgical motor recommended drilling speed 100 rpm and maximum torque 50 Ncm. as well as, using bone scrapper in push direction. * Xenogenic bone graft particles (De-proteinized bovine bone mineral small granules (0.25-1 mm). is added to the autogenous bone particles to obtain homogenous mixture ratio 1:1. * The gold standard is a mixture of autogenous bone containing viable cells and xenogenic bone which has slower rate of resorption is to be placed in recipient decorticated site and covered by PTFE membrane. * The assemble is to be fixed by titanium bone tacks of diameter 2.5 mm and length 3.5 mm, to avoid micro movements of particulate bone assembly. * In the Study group: The assemble is going to be covered by resorbable collagen membrane and fixed by tacks. * Recheck adequate flap advancement by visualizing passive flap approximation, to allow tension free closure. * Double line closure using horizontal mattress placed 5mm away from flap margins followed by interrupted sutures on top to allow contact area which is preferred to point contact and wound edge eversion.
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 sexes. * At least missing single tooth. * Previous Failed Implants. * Previous Failed Grafting. Exclusion Criteria: * Heavy smokers more than 20 cigarettes per day. * 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.
Contact & Investigator
Ahmed M. Youssef, PHD.
STUDY DIRECTOR
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Egypt
Frequently Asked Questions
Who can join the NCT06746935 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 48 Years, studying Ridge Augmentation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06746935 currently recruiting?
Yes, NCT06746935 is actively recruiting participants. Contact the research team at mohannadahmed@hotmail.com for enrollment information.
Where is the NCT06746935 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06746935 clinical trial?
NCT06746935 is sponsored by Cairo University. The principal investigator is Ahmed M. Youssef, PHD. at Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Egypt. The trial plans to enroll 20 participants.