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Clinical Trials/NCT06746935
NCT06746935RecruitingNot Applicable

Reconstruction of Deficient Atrophic Ridges Using Guided Bone Regeneration Technique With Native Collagen Membrane and Polytetrafluoroethylene Membrane (Randomized Clinical Trial)

Cairo University1 site in 1 country20 target enrollmentStarted: January 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Quantity of bone gain.

Study Overview

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.

Detailed Description

.General operative procedures The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group particulate bone mixture 1:1 autogenous and xenogenic bone covered with Polytetrafluoroethylene membrane and study group particulate bone mixture 1:1 autogenous and xenogenic bone 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.
  • Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine).

Both the study and control group will receive:

  • In Recipient site, preparation 1st to obtain, three-line pyramidal flap.
  • Flap advancement using periosteal releasing incision.
  • In Donor site, auto chip maker (ACM) is used for autogenous bone harvesting and xenogenic bone graft particles mixture ratio 1:1.
  • The assemble is to be fixed by titanium bone tacks. In the Study group: The assemble is going to be covered by collagen membrane.
  • 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The patients were randomly allocated into two groups utilizing Random Allocation Software version 2.0. then the allocation was concealed in opaque sealed envelopes. In both groups. The allocation was revealed to the operator just before the surgery. On the other hand, the patients, outcome assessor and the statistician who analyzed the collected data and performed the statistical analysis were blinded.

Eligibility Criteria

Ages
20 Years to 48 Years (Adult)
Sex
All
Accepts 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.

Arms & Interventions

Control Group B polytetrafluoroethylene membrane.

Active Comparator

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

Intervention: Polytetrafluoroethylene membrane. (Procedure)

Study Group A native collagen membrane.

Experimental

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

Intervention: Collagen membrane. (Procedure)

Outcomes

Primary Outcomes

Quantity of bone gain.

Time Frame: After 4 months from ridge augmentation.

Measured using linear measurements from Cone Beam Computed Tomography (CBCT) in millimeters (mm).

Secondary Outcomes

  • Soft tissue dehiscence.(Starting from Week 1. Binary Yes or No.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohannad Ahmed Ismail

Principle Investigator

Cairo University

Study Sites (1)

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