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Peri-implantitis - Reconstructive Surgical Therapy

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ClinicalTrials.gov Identifier: NCT03077061
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Osteology Foundation
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
The project will evaluate the potential benefit of the use of bone replacement graft as an adjunct to surgical therapy of peri-implantitis. The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140 systemically healthy patients diagnosed with peri-implantitis will randomly assigned to be treated with or without bone replacement graft. Outcome measures include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.

Condition or disease Intervention/treatment Phase
Peri-Implantitis Procedure: Open flap debridement Device: Bone replacement graft Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is designed as a two-arm randomized clinical trial.
Masking: Single (Outcomes Assessor)
Masking Description: Individuals assessing radiographic parameters will be masked to the intervention.
Primary Purpose: Treatment
Official Title: Reconstructive Surgical Therapy of Peri-implantitis-related Osseous Defects. A Multicenter Randomized Controlled Clinical Trial
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: Control - Open flap debridement
The surgical procedure includes flap elevation, debridement of the peri-implant defect and decontamination of the implant surfaces using saline for irrigation. Flaps are replaced in their original position and carefully sutured. Patients are provided with post-surgical information and thereafter called in for regular follow-up visits.
Procedure: Open flap debridement
Open flap debridement using saline as irrigation

Experimental: Test - Bone replacement graft
The surgical procedure is identical to the control procedure with the exception of the application of the bone replacement graft. Following decontamination, Bio-Oss Collagen® is placed into the peri-implant bony defect. Flaps are carefully sutured and patients are provided with the same information and follow-up as patients in the control group.
Procedure: Open flap debridement
Open flap debridement using saline as irrigation

Device: Bone replacement graft
Open flap debridement using saline as irrigation including a grafting procedure withBio-Oss Collagen®.
Other Name: Bio-Oss Collagen®




Primary Outcome Measures :
  1. Treatment success (year 1) [ Time Frame: Assessed at year 1 ]
    Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin

  2. Treatment success (year 3) [ Time Frame: Assessed at year 3 ]
    Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin

  3. Treatment success (year 5) [ Time Frame: Assessed at year 5 ]
    Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm


Secondary Outcome Measures :
  1. Radiographic outcomes [ Time Frame: Assessed at 1, 3 and 5 years ]
    Defect fill and crestal bone support

  2. Patient-reported outcomes [ Time Frame: Prior to intervention and at 1, 3 and 5 years ]
    Patient-reported outcomes assessed by questionnaire and in relation to baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • ≥1 implant (≥1 year of function) presenting with PPD ≥7 mm and BoP/Pus.
  • Confirmed bone loss ≥3 mm at same implant(s)

Exclusion Criteria:

  • Treated for peri-implantitis during previous 6 months
  • Intake of systemic or local antibiotics during previous 6 months
  • Systemic conditions affecting peri-implant tissues
  • Systemic conditions impeding surgical intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077061


Contacts
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Contact: Jan Derks, PhD +4631786 ext 3124 jan.derks@odontologi.gu.se
Contact: Tord Berglundh, Professor tord.berglundh@odontologi.gu.se

Locations
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Sweden
Department of Periodontology, Institute of Odontology Recruiting
Göteborg, Sweden, 40530
Contact: Jan Derks, PhD    0046 31 786 3124    jan.derks@odontologi.gu.se   
Contact: Tord Berglundh, Professor    0046 31786 3182    tord.berglundh@odontologi.gu.se   
Principal Investigator: Tord Berglundh, Professor         
Sub-Investigator: Jan Derks, PhD         
Sponsors and Collaborators
Göteborg University
Osteology Foundation
Investigators
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Principal Investigator: Tord Berglundh, Professor Göteborg University

Publications:

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03077061     History of Changes
Other Study ID Numbers: 1192-16
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases