The Use of Platelet-rich Fibrin (PRF) Membranes in Lateral Alveolar Ridge Augmentation When Jaw Bone is Missing Before Dental Implant Installation. A Study Comparing an Autogenous Bone Block Graft Covered Either by a (PRF) Membrane (Test) or Bone Substitute and a Barrier Membrane (Control)

NCT04350749 | Completed Phase 4 DMC

• 1 other identifier: Boneaugmentation1234
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Tooth loss can in many cases be treated with an artificial titanium root (dental implant) and subsequent manufacture of a porcelain crown. After the tooth is lost bone resorption of the existing jaw bone often occurs making implant placement difficult. Therefore, bone augmentation is often necessary before implant placement. Six months after the bone augmentation has been performed, the implant can be inserted into the jaw bone and after additionally 6 months the final porcelain crown can be mounted. Reconstruction of the jaw bone is often done by harvesting a bone block from the patient's own jaw. The bone block is harvested typically from the posterior part of the lower jaw, where after it is placed and fixated by screws in the part of the jaw where the bone is missing. Finally, the bone graft is covered with artificial bone substitute and a collagen membrane. Recent studies have suggested that adding platelet-rich fibrin (PRF) membranes will have an advantageously effect in reconstruction of the jaw bone and bone healing. PRF membranes are derived from a blood sample of the patient and has been introduced to accelerate soft tissue as well as bone healing. No comparative studies have been conducted in humans for the time being evaluating the effect of PRF in conjunction with bone augmentation. Therefore, the purpose of this study is to compare a control group with a test group in which the control group is treated in a standardized manner, while PRF is added to the bone graft in the test group. After 6 months of bone healing, a dental implant can be inserted in both groups using a standard technique. For the two groups, the following is examined:

1. 1.The final treatment outcome of the dental implant focusing on clinical outcome, radiologic outcome, aesthetic outcome, patient satisfaction.
2. 2.Bone changes over time with a focus on volume changes. In addition, focus on soft tissue healing.
3. 3.Bone healing assessed using bone biopsies taken in connection with the implant installation.

Conditions

Tooth-loss

Outcome Measures

Primary Outcomes (3)

• Difference of volumetric bone changes of the augmented bone 6 month after the primary bone augmentation procedure between the test and control group

  The change of the augmented bone volume is assessed by comparing CBCT scans at different timepoint: Baseline=Before bone augmentation;After bone augmentation=Immediate after bone augmentation; Follow-up= Prior to implant installation (6 month after the primary bone augmentation). The volumetric bone changes over time were calculated as bone resorption rate, i.e. the difference in bone volume two weeks after bone augmentation and bone volume 6 months after augmentation.

  6 month after the primary bone augmentation procedure

• Difference of the various tissue component of the augmented bone between the test and control group

  A cylindrical biopsy of the augmented region is retrieved perpendicularly to the lateral aspect of the augmented bone 6 month after the primary bone augmentation (in the same surgical phase as the implant installation). The bone biopsies are evaluated by histological and histomorphometric analyses with focus on vital bone, non-vital bone, soft tissue, and blood vessels

  6 month after the primary bone augmentation procedure (in the same phase as the implant installation).

• Difference of implant survival between the test and the control group

  Implant survival is registered at the final follow-up. Implant failure is defined as clinically visible implant mobility or removal of a stable implant due to progressive peri-implant bone loss or infection.

  Final follow-up 12 month after the implant supported crown is mounted (24 month after the primary bone augmentation)

Study Arms (2)

Test group (PRF group)

EXPERIMENTAL

PRF membrane is added to the bone block to evaluate if any effect on bone healing, soft healing, post-operativ pain

Biological: PRF is added in the test group.

Control group (Standard operation)

ACTIVE COMPARATOR

A standard bone augmentation procedure, which is weel-described is performed to compare the outcome of the test group

Biological: PRF is added in the test group.

Interventions

PRF is added in the test group. BIOLOGICAL

The PRF membrane can be considered as a biological membrane

Control group (Standard operation); Test group (PRF group)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tooth loss Atrophy of the alveolar process.

You may not qualify if:

• Oral pathology Bruxism. Allergies to bovine and porcine biomaterials

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Dentistry and Oral Health

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Hartlev J, Schou S, Isidor F, Norholt SE. A clinical and radiographic study of implants placed in autogenous bone grafts covered by either a platelet-rich fibrin membrane or deproteinised bovine bone mineral and a collagen membrane: a pilot randomised controlled clinical trial with a 2-year follow-up. Int J Implant Dent. 2021 Feb 8;7(1):8. doi: 10.1186/s40729-021-00289-z.

  PMID: 33554323 DERIVED

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sven Erik Noerholt, DDS

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Some of the data anlysis is masked. The examiner is blinded when performing the CBCT scan analysis of the volume (Study 2) and the histological assessment of the bone biopsies (Study 3)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical randomized controlled trial

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 17, 2020
• Study Start: January 15, 2015
• Primary Completion: June 1, 2017
• Study Completion: May 1, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)