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NCT Number: NCT06746935

Reconstruction of Deficient Atrophic Ridges Using Guide Bone Regeneration Technique

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.

Recruiting

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Key information

Age range

20 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University

Cairo, 11553, Egypt

Location status: Recruiting

Location contact

Ahmed M. Youssef, Lecturer

CONTACT

[email protected]

+201067941236 ext. +20

About this study

.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collagen membrane.

Procedure

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

Polytetrafluoroethylene membrane.

Procedure

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

Primary outcomes

  1. 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

  1. Soft tissue dehiscence.

    Time frame: Starting from Week 1. Binary Yes or No.

    Exposure of barrier membrane and impaied wound healing.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohannad A. Ismail, MSc.

CONTACT

[email protected]

+201222968444 ext. +20

Zeyad adel Mostafa., MSc.

CONTACT

[email protected]

+201062227776 ext. +20

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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