Skip to main content
OpenTrials
Completed

NCT Number: NCT03946020

GBR and Autogenous Bone Chips

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Resorption Bone Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A randomized controlled clinical trial (RCT) to compare the use of deproteinized bovine bone mineral (DBBM) in combination with autogenous bone chips versus a DBBM alone for the augmentation of bony dehiscence after dental implant placement

Objectives: 1. To test whether the use of DBBM is not inferior to the use of a combination of DBBM and autogenous bone chips for the filling of bony dehiscence around dental implants

  • To test whether a digital impression technique can be used to measure guided bone regeneration in comparison to conventional measurement with a dental probe and to compare these observations with cone beam CT images

Study Design: Randomized, controlled, single center, split mouth study

Study Population: Partially edentulous male or female patients in need for oral implants for a fixed prosthetic implant supported rehabilitation and where a Guide Bone Regeneration (GBR) procedure is indicated during implant treatment

Patient Number: 14

Duration of treatment: The time in the study for each patient will be 1 year and 4 months. The treatment period includes implant and abutment installation (in a twostage procedure), with a healing time of minimum 12 weeks before the start of the prosthetic phase.

Study devices: Implants: 3.3 / 4.1 / 4.8 mm Straumann Bone level implants Bone Graft: DBB (Demineralised Bovine Bone, Bio OSS) Measuring Devices: Cadent iTero & software and Dental Probes Prosthetics: Straumann (computer aided design computer aided manufacturing (CAD CAM) crowns and abutments

Outcome variables:

Primary outcome variable: Difference in bone fill between DBB + bone chips vs. DBB without bone chips afer 24 weeks of submerged healing. The "ideal bone volume" as defined at base line (= 100%) will be compared to the received bone fill [%] at re-entry measured by a digital impression technique (before and after GBR, and at abutment connection, before and after raising a flap, and at the 1-year follow-up).

The method of digital impression will be compared to CBCT immediately after implant placemetn and 1 year and periodontal probing during surgery and re-enty

Secondary Parameters:

Page 5 of 35 A comparison of 3 different tools (probe, CBCT and digital impression) for measuring the bone volume changes in relation to GBR procedures. Implant survival en success rates on a patient and implant level Marginal bone level alterations

Safety: Adverse Events / Adverse Device Effects

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Horizontal and vertical bone augmentation

    Time frame: 16 weeks

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

Secondary outcomes

  1. Success of grafting procedure as assessed by clinical interpretation

    Time frame: 1 year

    Defined as no persistent pain in the grafted area and no suppuration or expulsion of graft material and implant survival rates being lack of mobility, absence of peri-implant radiolucency, absence of recurrent peri-implant infection with suppuration, absence of continuous or recurrent pain, and no structural failure of the implant

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

    Time frame: 1 year

    measured from a reference point (implant shoulder) to the most coronal point of BIC, both mesially and distally

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
May 10, 2019
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.