Guided Bone Regeneration With Custom Made Meshes

NCT04942223 | Completed

• 1 other identifier: 121/2013
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

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.

Outcome Measures

Primary Outcomes (1)

• Bone regeneration volumes

  The bone reconstruction was calculated comparing the pre-operative and postoperative volumes. The Reconstructed Bone Volume (RBV) derived by subtracting the Lacking Bone Volume (LBV) values from Planned Bone Volume (PBV) ones. The pre-and postoperative CT datasets were converted into 3D models using Amira imaging software, version 5.3.3. The segmentation regarded almost the entire jaw structure to have at least six precise anatomical points of matching for the superimposition. After that, the pre and postoperative models were digitally aligned with Geomagic Studio 12 software. After the alignment was verified at a minimum range of tolerance of error level of ±0.37 mm in the areas no involved by the surgery, the measurements were performed. In every single slice, the space between the mesh profile and the basal bone was virtually selected and rendered to obtain the PBV; the area representative for the empty space according to the gray-scale of pixels was rendered for the LBV.

  6 months after surgery

Secondary Outcomes (3)

• Implant survival.

  1 year after implant loading at least.

• Complication rate

  through study completion, an average of 2 years.

• Implant success

  1 year after implant loading at least.

Study Arms (1)

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

OTHER

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.

Device: guided bone regeneration

Interventions

guided bone regeneration DEVICE

After local anesthesia, the surgery started with a mid-crestal incision with vertical releasing cuts followed by the full-thickness buccal and lingual/palatal flaps raising to expose the bone defect completely. The flaps were coronally extended to assure a complete closure with a passive suture above the titanium. Subsequently, an intra-oral mandibular ramus bone cortical block was harvested in the molar zone. The bone block was milled and mixed with freeze-dried. The particulate graft was put to fill the deficit above the mesh until its perfect stability and unity with the defect's borders. Two or three titanium mini-screws were used to stabilize the device , and the flaps were carefully sutured. Ceftriaxone was administered intravenously at a loading dose of 2 g; together with a non-steroidal analgesic, it was continued at two g/die per os beginning the day after surgery and continuing for six days.

Also known as: bone reconstruction

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Officials

• Giuseppe lizio, DDS

  University of Bologna (Italy) UNIBO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: prospective pilot cohort study

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 28, 2021
• Study Start: April 9, 2013
• Primary Completion: May 15, 2018
• Study Completion: December 31, 2020
• Last Updated: June 28, 2021

Record last verified: 2021-06