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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04462575
Enrollment
30
Registered
2020-07-08
Start date
2021-04-15
Completion date
2023-09-30
Last updated
2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Augmentation

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.

Interventions

PROCEDUREOnlay bone block covered using collagen membrane

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 46 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Quantity of bone gain.after 4 months from ridge augmentation.Measured using linear measurements from Cone Beam Computed Tomography (CBCT) in millimeters (mm).

Secondary

MeasureTime frameDescription
Bone Quality.after 4 months from ridge augmentation.Measured using Image Analyser Computer System using Histomorphometric method (area percent micrometer square) and optical density

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026