GBR and Autogenous Bone Chips

NCT03946020 | Completed

• 1 other identifier: S55609
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be an open, prospective, split-mouth, randomised controlled clinical trial. A total of 14 patients searching for oral implant treatment and where a GBR procedure is indicated per implant treatment will be enrolled. All patients have to fulfill all of the inclusion criteria and none of the exclusion criteria. From all patients clinical photos will be taken. Two sites within a patient will be randomly allocated to the 'autologous bone chips and DBBM or 'DBBM particles alone' group. The study will be 1 year follow-up study comprising 9 visits

Conditions

Bone Resorption

Keywords

implants; GBR; DBBM; grafts; bone

Outcome Measures

Primary Outcomes (1)

• Horizontal and vertical bone augmentation

  The change of dimension was assessed comparing Cone Beam Computed Tomography scans (CBCT)

  16 weeks

Secondary Outcomes (2)

• Success of grafting procedure as assessed by clinical interpretation

  1 year

• Marginal bone level alterations assessed on peri-apical radiographs using software (ImageJ)

  1 year

Study Arms (2)

Augmentation with autologous bone + DBBM

ACTIVE COMPARATOR

A layer of autogenous bone chips was placed on the implant surface. On top of this a layer of DBBM (Bio-Oss™, Geistlich®, Wolhusen, Switserland) was placed, thereafter covered with a collagen membrane.

Procedure: Guided bone regeneration with or without autologous bone

Augmentation with DBBM

EXPERIMENTAL

A layer of DBBM was placed on the implant surface and thereafter covered with a collagen membrane. Care was taken to make both augmentations as comparable as possible by weighting the used amount of graft material.

Procedure: Guided bone regeneration with or without autologous bone

Interventions

Guided bone regeneration with or without autologous bone PROCEDURE

Autogenous bone chips were collected. On each side a bone level implant was placed. The bone dehiscence was measured and was thereafter treated according to the GBR protocol. A resorbable native collagen was adapted to the defect.

Augmentation with DBBM; Augmentation with autologous bone + DBBM

Eligibility Criteria

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

You may qualify if:

• \> 18 years,
• in need of a solitary implant in quadrant 1 and 2 or quadrant 3 and 4 with simultaneous GBR procedure
• presence of a pre-operative CBCT.

You may not qualify if:

• smokers
• patients with systemic diseases that could interfere with the healing
• patients undergoing bisphosphonate treatment
• patients who previously received radiation therapy of the jaws
• patients that received a GBR procedure in the region of interest in the past.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (1)

• Temmerman A, Cortellini S, Van Dessel J, De Greef A, Jacobs R, Dhondt R, Teughels W, Quirynen M. Bovine-derived xenograft in combination with autogenous bone chips versus xenograft alone for the augmentation of bony dehiscences around oral implants: A randomized, controlled, split-mouth clinical trial. J Clin Periodontol. 2020 Jan;47(1):110-119. doi: 10.1111/jcpe.13209. Epub 2019 Nov 5.

  PMID: 31602699 DERIVED

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Andy Temmerman, DDS, MSc, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

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: Clinical Professor

Model Details: Split mouth

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 10, 2019
• Study Start: June 1, 2013
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share