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

Cairo University (CU)

Status: Enrolling

Conditions: Bone Augmentation

Treatments: Procedure: Onlay bone block covered with collagen membrane; Procedure: Onlay bone block without collagen membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT06900933

0-0002-9582-5106

Details and patient eligibility

About

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?

Full 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 example Geistlich Bio-Gide or Jason Membrane Botiss.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Study Group A: Retromolar bone block covered with collagen membrane.

Experimental group

Description:

The onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site. The assembly is going to be covered with native collagen membrane and fixed with titanium bone tacks.

Treatment:

Procedure: Onlay bone block covered with collagen membrane

Control Group B: Retromolar bone block without collagen membrane.

Active Comparator group

Description:

The onlay bone block harvested from retromolar region and fixed with micro screws, a mixture of autogenous and xenogenic particulate bone graft is going to be packed in between the bone block and recipient site.

Treatment:

Procedure: Onlay bone block without collagen membrane