Reconstruction of Deficient Atrophic Ridges Using Guide Bone Regeneration Technique

February 16, 2025 updated by: Mohannad Ahmed Ismail, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group B polytetrafluoroethylene membrane.
Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane.
Procedure: Polytetrafluoroethylene membrane.
Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane.
Experimental: Study Group A native collagen membrane.
Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane.
Procedure: Collagen membrane.
Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
After 4 months from ridge augmentation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue dehiscence.
Time Frame: Starting from Week 1. Binary Yes or No.
Exposure of barrier membrane and impaied wound healing.
Starting from Week 1. Binary Yes or No.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment.
Time Frame: Day 1.

Location,onset and character. Using questionnaire. Using Visual Analogue Scale. Numerical from 0 to 10. 0 no pain and 10 the worst pain.

  • Numerical from 0 to 10. Questionnaire.
  • Numerical from 0 to 10.
  • Questionnaire.
  • Numerical from 0 to 10.
Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Ahmed M. Youssef, PHD., Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

October 29, 2025

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 16, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-0001-6142-0568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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