Clinical trial NCT04942223: Guided Bone Regeneration With Custom Made Meshes
Official title: Guided Bone Regeneration With Custom Made Meshes in the Dental Rehabilitation of Three Dimensional and Extended Defect of the Jaws.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: virtual planning, GBR, titanium meshes.
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective pilot cohort study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone regeneration volumes
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Implant survival.
timeFrame: 1 year after implant loading at least.
measure: Complication rate
timeFrame: through study completion, an average of 2 years.
measure: Implant success
timeFrame: 1 year after implant loading at least.
Other outcomes:
Locations:
Study officials:
affiliation: University of Bologna (Italy) UNIBO
name: Giuseppe lizio, DDS
role: PRINCIPAL_INVESTIGATOR
References: