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

NCT06648564 | Enrolling By Invitation

• 1 other identifier: P-i regenerative surg 20-25 y
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implantitis

Keywords

peri-implantitis; regenerative surgery; long time follow-up

Outcome Measures

Primary Outcomes (1)

• Bone fill

  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 Outcomes (1)

• Probing pocket depths changes

  Ten years after surgical regenerative boneprocedures

Other Outcomes (2)

• Bleeding

  Ten years after surgical regenerative boneprocedures

• Graded bleeding

  Ten years after surgical regenerative boneprocedures

Study Arms (2)

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

Group 2

Bone regenerativ surgery with a bone graft material (Algipore)

Interventions

Bone regenerative surgery with a bone graft substitute and a resorbable membrane PROCEDURE

Dental implants with a diagnosis peri-implantitis were treated with regenerative surgery.

Also known as: Bone regenerative surgery with a bone graft substitute

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Kristianstad University: lead

Study Sites (1)

Kristianstad Univeristy

Kristianstad, 29893, Sweden

Location

Related Publications (3)

• Roos-Jansaker AM, Persson GR, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a 5-year follow-up. J Clin Periodontol. 2014 Nov;41(11):1108-14. doi: 10.1111/jcpe.12308. Epub 2014 Oct 17.

  PMID: 25195613 BACKGROUND

• Roos-Jansaker AM, Lindahl C, Persson GR, Renvert S. Long-term stability of surgical bone regenerative procedures of peri-implantitis lesions in a prospective case-control study over 3 years. J Clin Periodontol. 2011 Jun;38(6):590-7. doi: 10.1111/j.1600-051X.2011.01729.x. Epub 2011 Apr 13.

  PMID: 21488935 BACKGROUND

• Roos-Jansaker AM, Renvert H, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a prospective cohort study. J Clin Periodontol. 2007 Jul;34(7):625-32. doi: 10.1111/j.1600-051X.2007.01102.x.

  PMID: 17555414 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• AM R Jansaker, Ass.Prof.

  Malmö University

  STUDY DIRECTOR

• Stefan Renvert, Prof.

  Kristianstad University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phD

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: August 31, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

SE (1)