NCT02375750

Brief Summary

The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to peri-implantitis disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

2.4 years

First QC Date

July 7, 2014

Last Update Submit

February 22, 2019

Conditions

Peri-implantitis

Outcome Measures

Primary Outcomes (1)

  • Change in the dimensions of the bone defect

    6 months, 1 year

Secondary Outcomes (4)

  • Change in pocket depth

    3 months,6months, 9 months,12months

  • Change in gingival inflammation

    3 months,6months, 9 months,12months

  • Changes in recession of the mucosal margin

    3 months,6months, 9 months,12months

  • Subject satisfaction with the outcome at the study end

    12months

Study Arms (2)

GBO and GBG

EXPERIMENTAL

0.2 g-0,5 g GBO and 1 GBG once after decontamination of implant surface

Device: GBO and GBG

Standard treatment

ACTIVE COMPARATOR

Decontamination of surface of implant

Other: Standard treatment

Interventions

GBO and GBGDEVICE

Application of GBO and GBG to the defect fill after removal of chronic inflammatory tissue and decontamination of the surface of implant

GBO and GBG
Standard treatmentOTHER

Removal of chronic inflammatory tissue using titanium curettes and a rotary titanium brush; Implant Surface decontamination and closure by suturing

Standard treatment

Eligibility Criteria

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

You may qualify if:

  • age 18 years or older
  • Presence of peri-implantitis
  • A peri-implant intraosseous defect with at least 3 mm defect depth as seen on an intraoral radiograph.
  • Clinically a probing depth ≥ 5 mm combined with bleeding and/or pus should be present at the site.
  • During surgical exploration an intraosseous component of at least 3 mm at the deepest point must be present.
  • The defect should have a minimum of 3 osseous walls (a circumference of the osseous defect of at least 270 degrees). Only 3 and 4 wall intraosseous defects will be included.
  • Implants included in the study must have been in function for more than 12 months.
  • Ability to fully understand the nature of the proposed surgery and ability to sign an Ethics Committee-approved informed consent form

You may not qualify if:

  • Subjects with diabetes mellitus (HbA1c \> 7.0)
  • Subjects taking prednisone or other anti-inflammatory prescription drug
  • Subjects taking medications known to have effects on gingival growth
  • General contraindications for dental and/or surgical treatments
  • Smokers (\> 10 cigarettes per day).
  • Pregnant or lactating women
  • Allergy to collagen
  • Inability to consent for participation in the study and/or to accept the proposed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristianstad University, Department of Health Sciences

Kristianstad, 29188, Sweden

Location

Related Publications (2)

  • Renvert S, Giovannoli JL, Rinke S. The efficacy of reconstructive therapy in the surgical management of peri-implantitis: A 3-year follow-up of a randomized clinical trial. J Clin Periodontol. 2024 Oct;51(10):1267-1276. doi: 10.1111/jcpe.14049. Epub 2024 Jul 17.

    PMID: 39020503DERIVED

  • Renvert S, Giovannoli JL, Roos-Jansaker AM, Rinke S. Surgical treatment of peri-implantitis with or without a deproteinized bovine bone mineral and a native bilayer collagen membrane: A randomized clinical trial. J Clin Periodontol. 2021 Oct;48(10):1312-1321. doi: 10.1111/jcpe.13513. Epub 2021 Jul 29.

    PMID: 34169551DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Stefan Renvert, Professor

    Department of Health Sciences, Kristianstad University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2014

First Posted

March 3, 2015

Study Start

September 1, 2014

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)