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

Primary Purpose

Bone Augmentation

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Onlay bone block covered using collagen membrane
Onlay bone block without collagen membrane
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Augmentation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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.

Sites / Locations

  • Al Kasr Al Ainy UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Onlay bone block covered using collagen membrane

Onlay bone block without collagen membrane

Arm Description

The onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block) covered by collagen membrane, stabilized by resorbable suture and fixed by tacs.

The onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 28, 2020
Last Updated
July 7, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04462575
Brief Title
Reconstruction of Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane
Official Title
Reconstruction of Horizontally Deficient Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Augmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Onlay bone block covered using collagen membrane
Arm Type
Experimental
Arm Description
The onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block) covered by collagen membrane, stabilized by resorbable suture and fixed by tacs.
Arm Title
Onlay bone block without collagen membrane
Arm Type
Active Comparator
Arm Description
The onlay bone block (harvested from mandibular intra oral sites) on top of a mixture of particulate autogenous bone and particulate xenogenic bone (assembly going to be fixed by at least 2 micro screws of diameter 1.5 mms and length 13 mms, to avoid micro movements of onlay bone block).
Intervention Type
Procedure
Intervention Name(s)
Onlay bone block covered using collagen membrane
Intervention Description
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..
Intervention Type
Procedure
Intervention Name(s)
Onlay bone block without collagen membrane
Intervention Description
Onlay bone block without collagen membrane
Primary Outcome Measure Information:
Title
Quantity of bone gain.
Description
Measured using linear measurements from Cone Beam Computed Tomography (CBCT) in millimeters (mm).
Time Frame
after 5 months from ridge augmentation.
Secondary Outcome Measure Information:
Title
Bone Quality.
Description
Measured using Image Analyser Computer System using Histomorphometric method (area percent micrometer square) and optical density
Time Frame
after 5 months from ridge augmentation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niveen A. Askar, Professor
Phone
+201001558769
Ext
+20
Email
niveen.askar@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hesham A. Fattouh, Professor
Phone
+201154198000
Ext
+20
Email
hesham.fattouh@dentistry.cu.edu.eg
Facility Information:
Facility Name
Al Kasr Al Ainy University
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niveen A. Askar, Professor
Phone
+201001558769
Ext
+20
Email
niveen.askar@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Hesham A. Fattouh, Professor
Phone
+201154198000
Ext
+20
Email
hesham.fattouh@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
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Reconstruction of Atrophic Maxillary Ridges Using Mandibular Blocks With and Without Coverage Using Collagen Membrane

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