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Recruiting NCT06900933

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

No phase Interventional Bone Augmentation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Onlay bone block covered with collagen membrane, Onlay bone block without collagen membrane.
Who it may be relevant to
Registry conditions: Bone Augmentation. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

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 example Geistlich Bio-Gide or Jason Membrane Botiss.

Interventions

  • Procedure Onlay bone block covered with collagen membrane
    Onlay bone block covered with collagen membrane
  • Procedure Onlay bone block without collagen membrane
    Onlay bone block covered without collagen membrane

Primary outcome measures

  • Quantity of bone gain. [Time frame: At 5 months from ridge augmentation.]
Secondary outcome measures (1)
  • Soft Tissue Dehiscence [Time frame: Baseline 1st Week. Written Binary Numerical Yes or No.]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry Cairo University — Cairo

Publications

  • Hammerle CH, Jung RE. Bone augmentation by means of barrier membranes. Periodontol 2000. 2003;33:36-53. doi: 10.1046/j.0906-6713.2003.03304.x. No abstract available. PMID 12950840
  • Cash and Alex: 20 years of guided bone regeneration in implant dentistry, 2nd ed. (2009).
  • Urban, I A., Nagrusky H, Lozada JM:
  • Urban, I A., Nagrusky H, Lozada JM.:
  • Pellegrino G, Lizio G, Corinaldesi G, Marchetti C. Titanium Mesh Technique in Rehabilitation of Totally Edentulous Atrophic Maxillae: A Retrospective Case Series. J Periodontol. 2016 May;87(5):519-28. doi: 10.1902/jop.2016.150432. Epub 2016 Jan 12. PMID 26759078
  • Polis-Yanes C, Cadenas-Sebastian C, Gual-Vaques P, Ayuso-Montero R, Mari-Roig A, Lopez-Lopez J. Guided Bone Regeneration of an Atrophic Maxilla Using Heterologous Cortical Lamina. Case Rep Dent. 2019 Jun 11;2019:5216362. doi: 10.1155/2019/5216362. eCollection 2019. PMID 31308978
  • Jensen J, Sindet-Pedersen S. Autogenous mandibular bone grafts and osseointegrated implants for reconstruction of the severely atrophied maxilla: a preliminary report. J Oral Maxillofac Surg. 1991 Dec;49(12):1277-87. doi: 10.1016/0278-2391(91)90303-4. PMID 1955919
  • Montazem A, Valauri DV, St-Hilaire H, Buchbinder D. The mandibular symphysis as a donor site in maxillofacial bone grafting: a quantitative anatomic study. J Oral Maxillofac Surg. 2000 Dec;58(12):1368-71. doi: 10.1053/joms.2000.18268. PMID 11117684

Identifiers

NCT: NCT06900933 · 0-0002-9582-5106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗