Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges

Cairo University (CU)

Status: Unknown

Conditions: Bone Resorption Disorder

Treatments: Procedure: GBR by xenograft and autogenous bone

Study type: Interventional

Funder types: Other

Identifiers

NCT03731416

Guided bone regeneration

Details and patient eligibility

About

This study is aiming to evaluate clinically, radiographically ,and histologically GBR using collagen membrane in combination with a mixture of ABBM and autogenous particulated bone compared to collagen membrane with ABBM in atrophied anterior maxilla.

Full description

Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques.6,8 To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Expanded polytetrafluoroethylene (e-PTFE) membranes are the most used non-resorbable membranes with the longest published follow-up, considering them the gold standard in the reconstructions of major horizontal bone defects. However, a second surgery is needed to remove them and they may get exposed in the oral cavity and contaminate with possible infection and graft loss. Conversely, the resorbable membranes most advantages are an ability to merge with the host tissues, as well as a rapid resorption in case of exposure, thereby reducing the risk of bacterial contamination. Resorbable membranes in combination with particulated anorganic bovine bone (ABB) can be used for the augmentation of horizontally deficient ridges. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with atrophied anterior maxillary ridge area.
• Age: 18 years and older.
• Both sexes.
• No intraoral soft and hard tissue pathology.
• No systemic condition that contraindicate bone augmentation

Exclusion criteria

• • Heavy smokers more than 20 cigarettes per day.(32)

  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems.
  • Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
  • Pregnant or nursing women.
  • Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
  • Patient with previous history of radiotherapy.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

10 participants in 2 patient groups, including a placebo group

GBR by xenograft

Placebo Comparator group

Description:

* Patients of both groups will be subjected to CBCT (diagnostic for upper arch). * Intra operative procedures (for both groups) followed by CBCT will be taken for every patient. * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * Flap will be done. * In the study group: bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks. * • The site will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using interrupted 4/0 resorbable sutures.

Treatment:

Procedure: GBR by xenograft and autogenous bone

GBR by xenograft ,autogenous bone

Active Comparator group

Description:

Intervention In the control group:first crestal incision then two vertical incisions by blade 15c,full thickness flap reflection, bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area(atrophic maxilla) then covered by a native collagen membrane which will be stabilized by tacks.Then The flap will then be closed using interrupted 4/0 resorbable sutures.

Treatment:

Procedure: GBR by xenograft and autogenous bone