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NCT Number: NCT06900933

Reconstruction of Deficient Maxillary Ridges Using Retromolar Blocks With and Without Collagen Membrane

Is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in Maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quantity?

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Key information

Conditions

Age range

20 year–40 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

Niveen A. Askar, Professor

CONTACT

[email protected]

+201001558769 ext. +20

About this study

Soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. Any attempt of bone recontouring and resuturing fails since there is no vascular bed. Ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. Space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. Some types of collagen membrane, contain some degrees of stretchability example Geistlich Bio-Gide or Jason Membrane Botiss.

Who can participate

Healthy volunteers accepted: Yes

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 genders.
  • At least missing single tooth.
  • Previous Failed Implants.
  • Previous Failed Grafting.

Exclusion criteria

  • • Heavy smokers more than 20 cigarettes per day.
  • Patients with alcohol abuse
  • Patients with narcotic abuse.
  • 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.
  • Pregnant females.
  • Patients with Para functional habits, apprehensive and non-cooperative.
  • Bone pathology related to the site to be grafted.
  • Psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations.
  • Intraoral soft and hard tissue pathology.
  • Systemic condition that contraindicate implant placement.
  • Under the age of 18 years.

Treatment and study plan

Onlay bone block covered with collagen membrane

Procedure

Onlay bone block covered with collagen membrane

Onlay bone block without collagen membrane

Procedure

Onlay bone block covered without collagen membrane

Primary outcomes

  1. Quantity of bone gain.

    Time frame: At 5 months from ridge augmentation.

    Measured using linear measurements from Cone Beam Computed Tomography in millimeters.

Secondary outcomes

  1. Soft Tissue Dehiscence

    Time frame: Baseline 1st Week. Written Binary Numerical Yes or No.

    Exposure of bone block assembly and impaired healing

Study contacts

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

Mohannad A. Ismail, MSc.

CONTACT

[email protected]

01222968444 ext. +20

Niveen A. Askar, PhD

CONTACT

[email protected]

01001558769 ext. +20

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Retromolar Blocks With and Without Coverage Using Collagen Membrane (Randomized Clinical Trials)

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 28, 2025
Registry last updated
Jul 16, 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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