NCT04709523

Brief Summary

The aim of the study was to compare the change in augmentation thickness after guided bone regeneration (GBR) using bovine-derived xenograft in combination with or without injectable platelet-rich fibrin (i-PRF). This randomized-controlled clinical trial was conducted on patients with horizontal bone deficiency in the posterior regions of mandible. After implant placement, GBR procedures were randomly performed using i-PRF enriched bovine-derived xenograft (test group) or bovine derived xenograft alone (control group). Cone-beam computed tomography was taken at the implant sites immediately, and 6 months after surgery for assess the change in augmentation thickness as the primary outcome of the study. The secondary outcomes included marginal bone level and implant survival rate.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

January 13, 2021

Last Update Submit

February 20, 2021

Conditions

Bone Resorption

Keywords

Guided bone regenerationBovine-derived xenograftInjectable platelet-rich fibrin

Outcome Measures

Primary Outcomes (1)

  • Augmentation thickness

    the change in augmentation thickness at surgical site.

    at immediately and at 6 months

Secondary Outcomes (1)

  • Marginal bone level

    at immediately, at 6 months, at 12 months and at 24th months

Study Arms (2)

i-PRF enriched bovine-derived xenograft

EXPERIMENTAL

Patients treated with i-PRF-enriched bovine-derived xenograft + resorbable membrane

Procedure: bovine-derived xenograft with i-PRF

bovine-derived xenograft

EXPERIMENTAL

Patients treated with bovine-derived xenograft + resorbable membrane

Procedure: bovine-derived xenograft alone

Interventions

bovine-derived xenograft with i-PRFPROCEDURE

Bovine-derived xenograft was mixed with i-PRF and was placed in the augmentation site.

i-PRF enriched bovine-derived xenograft
bovine-derived xenograft alonePROCEDURE

Bovine-derived xenograft was placed in the augmentation site.

bovine-derived xenograft

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • horizontal deficiency of the alveolar bone in the posterior regions of mandible
  • absence of periodontal disease or previously treated
  • with blood tests showing platelet counts at least 150.000 mm3
  • ability to understand and accept the requirements of the study.

You may not qualify if:

  • any disorders or infection at the implantation site or adjacent tissue
  • tooth loss or extraction in the planned implant site within 6 months
  • poor oral hygiene
  • medical conditions that compromised tissue healing (uncontrolled diabetes, etc.)
  • treatments with an interfering medications (bisphosphonates, steroids etc.)
  • smoking habit
  • pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Resorption

Interventions

proliferation regulatory factors, human urine

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 14, 2021

Study Start

January 4, 2017

Primary Completion

March 4, 2018

Study Completion

November 23, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02