Lateral Ridge Augmentation Using Allograft Blocks and GBR for Implant Sites

NCT03879967 | Completed

• 1 other identifier: Allo_3_OCS_zmkUnibe
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Clinicians are increasingly faced with the challenge of reconstructing the alveolar ridge as more patients desire fixed implant-supported restorations. Reconstruction of large horizontal alveolar defects still remains a challenge in implantology. Although autogenous blocks from intraoral sites are proven effective for such defects, donor site morbidity and limited graft availability are major limitations. Allogenic bone blocks have been proposed to overcome these limitations, however, the outcomes reported in the literature are inconclusive. In this case series, the efficacy of allogenic blocks for lateral augmentation of atrophic ridges was evaluated, over a three-year period. In nineteen edentulous sites from ten patients, cortico-cancellous allogenic blocks (PHOENIX, TBF, France) were shaped to the defect and screw-fixated. A double-layer of autogenous chips and demineralized bovine bone (Bio-Oss, Geistlich Pharma AG, Switzerland) was used to fill the voids. The augmented site was covered by non-cross-linked collagen membrane (Bio-Gide, Geistlich Pharma AG, Switzerland). After a healing period of 9 months, implants were placed and CBCT analysis was performed post-implantation. Following a period of 34 months of function (range 22 to 44 months), patients were clinically and radiographically re-examined.

Conditions

Alveolar Ridge Augmentation

Keywords

Allograft block; guided bone regeneration; implants

Outcome Measures

Primary Outcomes (2)

• Change in ridge thickness with use of the allograft block

  The change in ridge thickness was measured in mm at a specific reference point 4mm apical to the shoulder of the implant. The measurements were done from a CBCT image in the coronal/sagittal plane.

  The measurements were done at approximately 9 months after ridge augmentation surgery and prior to implant placement.

• Change in ridge thickness with use of the allograft block after implant placement

  The change in ridge thickness was measured in mm at a specific reference point 4mm apical to the shoulder of the implant. The measurements were done from a CBCT image in the coronal/sagittal plane.

  The measurements were done at the follow-up appointment approximately 3years after implant placement.

Secondary Outcomes (15)

• Peri-implant suppuration

  Recorded at the 3years follow-up time point

• Modified plaque index by Mombelli

  Recorded at the 3years follow-up time point

• Modified sulcus bleeding index by Mombelli

  Recorded at the 3years follow-up time point

• Probing depth

  Recorded at the 3years follow-up time point

• Distance from the implant shoulder to the mucosal margin

  Recorded at the 3years follow-up time point

Study Arms (1)

Allograft block graft

EXPERIMENTAL

For lateral alveolar ridge augmentation, all patients will be treated with allograft block with guided bone regeneration. After a minimal healing phase of six months, implants would be placed in the augmented site. After a healing phase of about 4months, the implants would be loaded and then followed until the control appointment approximately 3 years later.

Device: Allograft block graft

Interventions

Allograft block graft DEVICE

The graft used is a mineralized, cortico-cancellous, delipidized, lyophilized allogenic block.

Allograft block graft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Atrophy of the alveolar ridge in the horizontal plane (\<4 mm in posterior sites and \<5 mm in anterior sites), or a crest width 5 mm in esthetic sites.
• Patients who agree to sign an informed consent.

You may not qualify if:

• Patients who had adequate horizontal ridge thickness and did not require ridge augmentation
• Patients with deficient vertical height of the ridge requiring vertical augmentation
• Patients who were not ready for implant supported prosthesis

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Oral Surgery and Stomatology, ZMK, University of Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• Chappuis V, Cavusoglu Y, Buser D, von Arx T. Lateral Ridge Augmentation Using Autogenous Block Grafts and Guided Bone Regeneration: A 10-Year Prospective Case Series Study. Clin Implant Dent Relat Res. 2017 Feb;19(1):85-96. doi: 10.1111/cid.12438. Epub 2016 Jul 31.

  PMID: 27476677 BACKGROUND

Study Officials

• Daniel A Buser Prof, DDS,DMD

  Department of Oral Surgery and Stomatology, ZMK, University of Bern

  STUDY CHAIR

• Vivianne Chappuis Prof, PD, DMD

  Department of Oral Surgery and Stomatology, ZMK, University of Bern

  STUDY DIRECTOR

• Odette Engel, Dr med dent

  Department of Oral Surgery and Stomatology, ZMK, University of Bern

  PRINCIPAL INVESTIGATOR

• Supriya Ebenezer, BDS, MDS

  Department of Oral Surgery and Stomatology, ZMK, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A group of thirteen patients were selected for lateral ridge augmentation using cortico-cancellous allogenic block with guided bone regeneration. After the first surgery a healing phase was given and then a second surgery for implant placement in these augmented sites was carried out. Post healing, the implants were prosthetically restored and followed up upto three years.

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 19, 2019
• Study Start: June 11, 2013
• Primary Completion: December 7, 2016
• Study Completion: May 14, 2018
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)