20-25 Year Follow-Up on Regenerative Bone Procedures for Peri-Implantitis (periimpl20y)

February 12, 2025 updated by: Viveca Wallin Bengtsson, Kristianstad University

20-25 Year Follow-Up After Surgical Treatment of Peri-Implantitis Using a Bone Substitute with or Without a Resorbable Membrane: a Longitudinal Study

The goal of this 20-25-year observational study is to investigate the outcomes of bone regenerative surgery in peri-implantitis. Two different techniques will be compared: surgery with a bone substitute alone and surgery with a bone substitute combined with a membrane, to determine their effectiveness and assess whether one is more effective than the other. The intention of this observational study is to learn more about the long-term effects of bone regenerative surgery in patients with peri-implantitis.

Patients will be called in for a clinical and radiographic examination of the surgically treated implant(s). Probing pocket depths, presence of pus, bleeding around the implant (s) and a radiograph of the implant (s).

To be able to compare with the 1, 3, 5 and 10 year measurements.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The aim of this 20-25 year observational follow-up study is to investigate the outcomes of bone regenerative surgery in peri-implantitis. The study compares two approaches: Group 1: surgery with a bone substitute alone (Algipore) and Group 2: surgery with a bone substitute (Algipore) combined with a membrane (Osseoquest). Both groups received systemic antibiotics-Amoxicillin 375 mg three times a day combined with Metronidazole 400 mg twice a day for 10 days, starting the day before surgery.

The objective of this observational study is to gain insights into the long-term effects of bone regenerative surgery in patients with peri-implantitis and to determine if there is a difference.

The patients were enrolled in a strict maintenance program with supportive therapy every third months with a yearly evaluation.

In this study, patients will examined of the surgically treated implant(s) after 20-25 years. The examination will include a clinical assessment, measuring probing pocket depths at each implant to the nearest millimeter using a standardized probing force of 0.25 N (Hawe-Click Probe, Kerr Hawe SA Bioggio, Switzerland). The prevalence of pus, full-mouth bleeding on probing, and bleeding grades will be recorded around the implant(s) at four sites per tooth and implant(s) as follows: 0 = no bleeding, 1 = point of bleeding, 2 = line of bleeding, and 3 = drop of bleeding. The plaque index will be defined as either visible or not visible at the implant site using an erythrosine dye (TopDent Lifco Dental AB, Enköping, Sweden). All clinical assessments will be performed by the same periodontist (AMRJ).

Data from the clinical treatment were registered in patient records. In parallel, clinical data were documented in a study protocol and saved in a safe in accordance with standard operation procedure at the clinic.The protocol with medical records were not opened until the study was completed and only by authorized persons with access to the data in the study such as, principal investigator and statisticians.

In accordance with an international working group diagnosis of peri-implantitis should include pocket depth, bleeding, and bone loss (X-ray). Thus, in this study the primary outcomes are radiographic evidence of bone fill and changes in probing depths at implants treated.

Parametric tests (independent t-tests, equal variance not assumed), and non-parametric tests (Mann-Whitney U-test, Wilcoxon test) will be performed to assess differences over time and between groups. Statistical significance will be declared at p <0.05. The Kolmogorov- Smirnov test will be used to define if the data presented with normal distribution or not. The SPSS PASW 29.0 statistical software (SPSS Inc., Chicago, IL, USA) for Apple computer will be used in the analysis.

Patients that will participate in the study will consecutively be given an ID code. and data will be registered in the ordinary patient journal. The code list will be placed in a locked up space, at the clinic.

All patients will be given oral and written information about the study and will sign a written informed consent. The patients will be informed that they could drop off when ever they want without any explanations. The ethical board approved the study.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Kristianstad, Sweden, 29893
        • Kristianstad Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with at least one dental implant with peri-implantitis

Description

Inclusion Criteria:

  • An implant demonstrating a progressive bone loss of ≥3 threads (≥1.8 mm) following the first year of healing
  • A vertical component needed to be present at the surgical intervention in order to justify the use of a bone augmentation procedure.
  • Bleeding on probing and/or suppuration should also be present

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Bone regenerativ surgery with a bone graft material (Algipore) and a resorbable membrane (Osseoquest)
Procedure: Bone regenerative surgery with a bone graft substitute and a resorbable membrane
Dental implants with a diagnosis peri-implantitis were treated with regenerative surgery.
Other Names:
  • Bone regenerative surgery with a bone graft substitute
Group 2
Bone regenerativ surgery with a bone graft material (Algipore)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone fill
Time Frame: Ten years after surgical regenerative boneprocedures
Radiographic bone fill measured mesial and distal at the implant on an intra oral radiograph. Measurements will be performed by a blinded radiologist.
Ten years after surgical regenerative boneprocedures

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket depths changes
Time Frame: Ten years after surgical regenerative boneprocedures
Changes in probing pocket depth at the implant measured on 4 surfaces
Ten years after surgical regenerative boneprocedures

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: Ten years after surgical regenerative boneprocedures
Bleeding on probing measured at the implant on 4 sites.
Ten years after surgical regenerative boneprocedures
Graded bleeding
Time Frame: Ten years after surgical regenerative boneprocedures
Graded bleeding measured at the implant on 4 sites as: 0 = no bleeding, 1 = point of bleeding, 2 = line of bleeding, and 3 = drop of bleeding.
Ten years after surgical regenerative boneprocedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kristianstad University

Investigators

  • Study Director: AM R Jansaker, Ass.Prof., Malmö University
  • Study Chair: Stefan Renvert, Prof., Kristianstad University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-i regenerative surg 20-25 y

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

May be shared upon request

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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