NCT07678892

Brief Summary

The purpose of this 10 year observational follow-up study was to evaluate the long-term outcomes of reconstructive surgical treatment of peri-implantitis. Two treatment approaches have been compared using a bone substitute with or without a resorbable membrane.The objective was to assess their effectiveness and determine wheter one treatment strategy provided superior long-term outcomes. Participants were invited for clinical and radiographic examinations of the previously treated implant. Clinical assessments included probing pocket depth measurements, evaluation of bleeding on probing, presence of suppuration, and radiographic assessment of peri-implant bone levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2000

Longer than P75 for all trials

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

Study Start

First participant enrolled

March 1, 2000

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
13.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

12.8 years

First QC Date

June 25, 2026

Last Update Submit

June 30, 2026

Conditions

Peri-Implantitis

Keywords

peri.implantitisreconstructive surgerylong time follo-up

Outcome Measures

Primary Outcomes (1)

  • Bone fill

    Radographic bone fill measured mesial and distal in mm and percent at the implant on an intra-oral radiograph. Measurements will be performed by a blinded radiologist in mm and percent

    10 years after surgical reconstrucyive bone procedures

Secondary Outcomes (1)

  • Probing pocket depths changes

    10 years after surgical reconstructive bone procedures

Other Outcomes (2)

  • Bleeding

    10 years after surgical reconstructive bone procedures

  • Graded bleeding

    10 years after surgical reconstructive bone procedures

Study Arms (2)

Group 1

Bone reconstructive surgery with a bone graft material (Algipor) and a resorbable membrane (Osseoquest)

Procedure: Treatment with a bone graft and a membrane

Group 2

Bone reconstructive surgery with a bone graft material (Algipor)

Procedure: Treatment with a bone graft

Interventions

Treatment with a bone graft and a membranePROCEDURE

Dental implants with a diagnosis of peri-implantitis treated with reconstructive surgery and a bone graft and a membrane

Group 1
Treatment with a bone graftPROCEDURE

Dental, implants with a diagnosis of peri.implantitis treated with reconstructive surgery and a bone graft alone

Group 2

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristianstad University

Kristianstad, Kristianstad, 29198, 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: 25195613RESULT

  • 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: 21488935RESULT

  • 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: 17555414RESULT

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Ann-Marie R Jansåker

    Malmö University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

March 1, 2000

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 2, 2026

Record last verified: 2026-06

Locations

SE(1)