Guided Bone Regeneration With Custom Made Meshes

University of Bologna

Status: Completed

Conditions: The Presence of Horizontal and Vertical Alveolar Defects in Both Jaws, Inadequate for the Placement of at Least Two Fixtures, Even ≤6 mm Long Ones

Treatments: Device: guided bone regeneration

Study type: Interventional

Funder types: Other

Identifiers

NCT04942223

121/2013

Details and patient eligibility

About

Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final results. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.

Full description

The implant-borne rehabilitation of three-dimensional and extended alveolar defects is not simple in any case: anatomic and prosthetic demands often require bone reconstructive procedures. Up to date, we can entirely virtually simulate our treatment .The design and printing of a customized mesh mimicking the ideal reconstruction eliminate the intra-operative handling and trimming, with reduced surgical timings and minimal stress for the soft tissues.

The aim is to verify if virtual planning with a customized scaffold could improve the predictability of a complex bone reconstruction in terms of bone reconstruction and implant results.

Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final result: six months at least after surgery, a new cone-beam CT was taken;the pre-and postoperative CT datasets were converted into three-dimensional models and digitally aligned; the reconstructed bone volumes (RBV) were calculated according to the planned bone volumes (PBVs), outlining the areas under the mesh. These values were correlated with complications, atrophies' location and the entity of virtually planned bone volume. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The presence of horizontal and vertical alveolar defects in both jaws, inadequate for the placement of at least two fixtures, even ≤6 mm long ones;
• ≥ 18 years;
• informed consent signed.

Exclusion criteria

• acute or chronic infections in the head and neck;
• smoking >10 cigarettes per day;
• uncontrolled diabetes (glycated hemoglobin level > 7 mg/dL);
• a history of radiation therapy in the head or neck region;
• current antitumor chemotherapy;
• liver, blood, or kidney disease;
• immunosuppression;
• everyday corticosteroid use;
• pregnancy;
• inflammatory and autoimmune disease of the oral cavity;
• poor oral hygiene and motivation

Trial design

20 participants in 1 patient group

Subjects undergoing virtually planned GBR for extended and complex alveolar defects.

Other group

Description:

Subjects undergoing virtually planned GBR for extended and complex alveolar defects. The subjects were selected from the population of patients referring to the Oral \& Maxillofacial Surgery Unit of S.Orsola-Malpighi University Hospital for oral function rehabilitation. Eligibility criteria were: the presence of horizontal and vertical alveolar defects in both jaws, inadequate for the placement of at least two fixtures, even ≤6 mm long ones; ≥ 18 years; informed consent signed.

Treatment:

Device: guided bone regeneration