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Completed

NCT Number: NCT04462575

Reconstruction of Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using 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 quality and bone quantity?

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Key information

Conditions

Age range

18 year–46 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University

Cairo, 11553, Egypt

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.

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

Exclusion criteria

  • Heavy smokers more than 10 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. 18
  • 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 using collagen membrane

Procedure

The ratio is 40% of xenogenic bone particles (low resorption rate) to 60% of autogenous bone particles (contains viable cells) to be placed in recipient decorticated site and covered by onlay bone block..

Onlay bone block without collagen membrane

Procedure

Onlay bone block without collagen 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. Bone Quality.

    Time frame: after 4 months from ridge augmentation.

    Measured using Image Analyser Computer System using Histomorphometric method (area percent micrometer square) and optical density

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 8, 2020
Registry last updated
Jul 11, 2024

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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