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Clinical Trials in Egypt / NCT06746935
Recruiting Not applicable

Reconstruction of Deficient Atrophic Ridges Using Guide Bone Regeneration Technique

NCT06746935 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2025-02-19

Condition(s) studied

Ridge AugmentationBone Augmentation

Investigational drug(s) / intervention(s)

Collagen membrane.Polytetrafluoroethylene membrane.

Collagen membrane.: Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane.

Polytetrafluoroethylene membrane.: Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane.

Study 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

Sex
ALL
Min age
20 Years
Max age
48 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry Cairo University Cairo Egypt Recruiting

More Cairo University trials in Egypt

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06746935 on ClinicalTrials.gov ↗ ← All trials in Egypt