Guided Surgery for Horizontal Bone Augmentation

NCT05282862 | Unknown

• 1 other identifier: S61322
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the research project is to develop a novel protocol for guided bone regeneration (GBR) and assess whether such a patient specific 3D printed guide can improve the accuracy of the resulting bone augmentation when compared to conventional freehand protocols. This study will be an open, prospective, randomized controlled clinical trial. A total of 28 healthy adult patients requiring bone augmentation of an edentulous site with adjacent teeth prior to implant placement will be included in a clinical trial. All patients have to fulfill all inclusion criteria and none of the exclusion criteria. The total study duration for the patient will be around 7 months, from inclusion to final follow-up. A virtual plan representing the ideal shape of the augmentation will be prepared. Bone augmentation guides (molds) will be designed and 3D printed for each case. These molds will encompass the defect and the desired augmentation (including the overfill compensating for the expected resorption) on the buccal aspect, leaving a small access space on the coronal aspect of the defect which will be used to insert the grafting material. Additionally, they will have holes near the mesial, distal and apical edges allowing for fixation of the barrier membrane using pin placement when the mold is in position. Finally, they will extend to the occlusal surface of teeth adjacent to the defect site in order to allow precise positioning and will have a protrusion (handle) on the buccal aspect allowing for easier handling and positioning. The trial will have two groups, a freehand group where conventional bone augmentation surgery will be performed and the clinician will determine the shape of the graft manually, and a guided group where the guide described above will be used. A 50:50 mixture of DBBM and autogenous bone will be used for both groups, resulting in a composite graft. The graft will be covered by a resorbable collagen membrane.

Conditions

Edentulous Alveolar Ridge Atrophy

Keywords

implant; bone augmentation; GBR

Outcome Measures

Primary Outcomes (2)

• Accuracy of resulting graft, immediately post-operatively.

  Linear and volumetric difference between plan and resulting graft, measured on the post-op CBCT.

  Immediately after surgery

• Accuracy of resulting graft, 6 months after surgery

  Linear and volumetric difference between plan and resulting graft, measured on the CBCT taken 6 months after surgery.

  Six months after surgery

Study Arms (2)

Freehand

ACTIVE COMPARATOR

Conventional bone augmentation using a particulate graft material (DBBM) and a collagen barrier membrane.

Procedure: Horizontal bone augmentation

Guided

EXPERIMENTAL

Bone augmentation performed using the materials as in the Freehand group, but using a surgical guide to help define the shape of the guide.

Procedure: Horizontal bone augmentation

Interventions

Horizontal bone augmentation PROCEDURE

Horizontal bone augmentation of a limited span (1-2 teeth) edentulous ridge with neighboring teeth present.

Freehand; Guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of at least one site requiring bone augmentation prior to or simultaneously with implant placement;
• the above mentioned site should have adjacent teeth both mesially and distally;
• a history of edentulism in the area of implant treatment of at least 3 months;
• provision of informed consent.

You may not qualify if:

• unlikely to be able to comply with the study procedures, as judged by the investigator;
• untreated periodontal disease;
• known or suspected current malignancy;
• history of chemotherapy within 5 years prior to study;
• history of radiation in the head and neck region;
• history of other metabolic bone diseases;
• a medical history that makes bone augmentation or implant insertion unfavorable;
• need for systemic corticosteroids;
• current or previous use of intravenous bisphosphonates;
• current or previous use of oral bisphosphonates;
• history of bone grafting and/or sinus lift in the planned implant area;
• present alcohol and/or drug abuse;
• involvement in the planning and conduct of the study;
• previous enrolment in the present study.

Sponsors & Collaborators

• KU Leuven: lead
• ITI Foundation: collaborator

Study Sites (1)

UZ Leuven Sint Rafaël Campus

Leuven, 3000, Belgium

RECRUITING

Study Officials

• Mihai Tarce

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihai Tarce

CONTACT

+32 16 332483; mihai.tarce@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, PhD student

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: May 28, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

BE (1)