Assessment of GBR in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh

NCT03635658 | Unknown

• 1 other identifier: CEBD-CU-2018-08-12
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

this study is aiming to Assess postoperative complications and bone quality and quantity in augmentation of horizontally atrophic maxillary ridge using a 1:1 mixture of autograft and xenograft particulate bone covered with collagen membrane with the new Sausage technique™ versus using the same mixture covered with titanium mesh.

Conditions

Horizontal Ridge Deficiency

Outcome Measures

Primary Outcomes (3)

• membrane exposure

  clinical postoperative complications as flap dehiscence and membrane exposure into the oral cavity, its a binary outcome (yes/No) examined and recorded by the investigator.

  within 3 weeks

• infection

  suppuration collection related to the membrane and flap, its a binary outcome (yes/No) examined and recorded by the investigator.

  10 days

• inflammation

  redness and tenderness of the flap, its a binary outcome (yes/No) examined and recorded by the investigator.

  10 days

Secondary Outcomes (2)

• bone width gain

  at 6 months

• bone quality

  at 6 months

Study Arms (2)

titanium mesh

ACTIVE COMPARATOR

using non resorbable titanium mesh to fix and cover the onlay bone graft mixture to the atrophic maxillary ridge.

Procedure: titanium mesh

collagen membrane(Sausage technique)

EXPERIMENTAL

using resorbable collagen membrane with the sausage technique to fix the onlay bone graft mixture to the resorbed atrophic maxillary ridge

Procedure: collagen membrane (Sausage technique)

Interventions

titanium mesh PROCEDURE

the non resorbable titanium mesh is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.

titanium mesh

collagen membrane (Sausage technique) PROCEDURE

the resorbable collagen membrane is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.

collagen membrane(Sausage technique)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with horizontal atrophied maxillary ridge (thin ridge) less than 4mm.
• All ages and both sexes were included in this study.
• Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
• Patients with physical and psychological tolerance

You may not qualify if:

• Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. 8
• Heavy smokers.4
• Alcohol or drug abuse
• Gingival bleeding or full mouth plaque index ≥ 25%.4
• Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. 9
• Unavailability for regular follow-ups

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: because the two interventions used in this trial are clearly different and easily recognized by the investigator and the participants. neither the participant nor the investigator could be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer in oral and maxillofacial department cairo university

Model Details: the participants are divided into two groups one control and the other is the intervention

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: October 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: October 1, 2020
• Last Updated: August 17, 2018

Record last verified: 2018-08