NCT02860208

Brief Summary

The objective of this prospective clinical study was to evaluate the 3-year outcomes of anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant therapy (SPIT) programme was followed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

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

December 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

3 years

First QC Date

August 4, 2016

Last Update Submit

December 19, 2016

Conditions

Peri-Implantitis

Keywords

Peri-ImplantitisSurgical therapyFollow-upSupportive peri-implant therapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in treatment success at 3 years post-op

    treatment success is defined by pocket closure, no bleeding on probing, bone loss ≤0.5 mm between baseline and 3 years

    baseline (1 year post-op) and 3 years post-op

Study Arms (1)

3 years follow-up

all patients who received surgical treatment for peri-implantitis during a Randomized and Controlled Trial registered in ClinicalTrials.gov NCT NCT01857804

Procedure: 3 years follow-up

Interventions

3 years follow-upPROCEDURE

Examination 3 years after surgical treatment of peri-implantitis

3 years follow-up

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients who received surgical treatment for peri-implantitis during the RCT registered in ClinicalTrials.gov NCT NCT01857804

You may qualify if:

  • all patients who received surgical treatment for peri-implantitis for 3 years ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Sanz M, Chapple IL; Working Group 4 of the VIII European Workshop on Periodontology. Clinical research on peri-implant diseases: consensus report of Working Group 4. J Clin Periodontol. 2012 Feb;39 Suppl 12:202-6. doi: 10.1111/j.1600-051X.2011.01837.x.

    PMID: 22533957BACKGROUND

  • Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.

    PMID: 26285807BACKGROUND

  • Heitz-Mayfield LJA, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2018 Jan;29(1):1-6. doi: 10.1111/clr.12910. Epub 2016 Jun 23.

    PMID: 27335316BACKGROUND

  • Serino G, Turri A. Outcome of surgical treatment of peri-implantitis: results from a 2-year prospective clinical study in humans. Clin Oral Implants Res. 2011 Nov;22(11):1214-20. doi: 10.1111/j.1600-0501.2010.02098.x. Epub 2011 Feb 11.

    PMID: 21309860BACKGROUND

  • Serino G, Turri A, Lang NP. Maintenance therapy in patients following the surgical treatment of peri-implantitis: a 5-year follow-up study. Clin Oral Implants Res. 2015 Aug;26(8):950-956. doi: 10.1111/clr.12418. Epub 2014 May 26.

    PMID: 24861154BACKGROUND

  • Mettraux GR, Sculean A, Burgin WB, Salvi GE. Two-year clinical outcomes following non-surgical mechanical therapy of peri-implantitis with adjunctive diode laser application. Clin Oral Implants Res. 2016 Jul;27(7):845-9. doi: 10.1111/clr.12689. Epub 2015 Sep 16.

    PMID: 26374080BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Tord Berglundh, Professor

    Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share