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

Cairo University (CU)

Status: Unknown

Conditions: Horizontal Ridge Deficiency

Treatments: Procedure: titanium mesh; Procedure: collagen membrane (Sausage technique)

Study type: Interventional

Funder types: Other

Identifiers

NCT03635658

CEBD-CU-2018-08-12

Details and patient eligibility

About

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.

Full description

patients with atrophic maxillary ridge < 4 mm will be selected in this study for augmentation for future implant placement. The full thickness flap will be elevated including one extra tooth on each side of the edentulous area or if completely edentulous 5 mm on each side.. the bone bed will be prepared by cleaning any debris and Multiple decortication holes will be performed with a 2.0 mm round bur. the harvested bone from the chin is then mixed with the xenograft with ratio 1:1 and then put on the recipient site and will be covered with a collagen membrane with the Sausage technique (intervention group) and the other group the graft will be covered with titanium mesh (control group).

flap is repositioned and sutured. followup for 6 months and then CBCT is done. Reopening after 6 months, core biopsy is taken by a 2 mm thickness trephine from the healed augmented bone at the site of implant placement and will be sent for histomorphometric analysis and the bone thickness (buccolingual ) dimension is measured using a caliper and from the CBCT (cone beam CT) the bone width gain will be calculates and recorded.

postoperative complications( infection, wound dehiscence or membrane exposure) will be monitored and recorded.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

titanium mesh

Active Comparator group

Description:

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

Treatment:

Procedure: titanium mesh

collagen membrane(Sausage technique)

Experimental group

Description:

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

Treatment:

Procedure: collagen membrane (Sausage technique)