NCT04254406

Brief Summary

To report 10-years follow up of patients following the surgical treatment of peri-implantitis and to identify possible risk indicators for the progression of disease during supportive peri-implant therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 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

January 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

January 24, 2020

Last Update Submit

February 2, 2020

Conditions

Keywords

Peri-Implantitis surgeryTreatment outcomeRisk factors

Outcome Measures

Primary Outcomes (4)

  • Number patients with persisting peri-implantitis following peri-implant surgery

    The total number of patients with persisting peri-implantitis will be calculated. Any subject presenting at least one implants with a pathological pocket will be regarded as positive for the disease . The presence or absence of peri-implantitis will be assessed by using a periodontal probe around the mucosa of the implants. The definition of a pathological pocket around an implant is a pocket of 5 millimeters or more deep with concomitants bleeding after the use of the probe.

    10 years

  • Percentage of subjects with persisting peri-implantitis

    The percentage of patients with persisting peri-implantitis following peri-implantitis surgery will be calculated among all the patients that were treated. For definition of peri-implantitis see description at outcome 1.

    10 years

  • Number of implant with persisting peri-implantitis

    The number of implants with persisting clinical signs of peri-implantitis will be calculated. Any implant presenting a pathological pockets around its surface will be regarded as positive for the disease. For definition of peri-implantitis see description at outcome 1

    10 years

  • Percentage of implants wih persisting peri-implantitis

    The percentage of implants with persisting peri-implantitis after surgery will be calculated among all the implants that were surgically treated. For definition of peri-implantitis see description at outcome 1

    10 years

Secondary Outcomes (1)

  • Assessement of risk factors related to the persistence of peri-implantitis

    10 years

Interventions

Evaluation of routine treatment

Eligibility Criteria

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

Consecutive patients who had received routine surgical treatment of peri-implantitis between 2007 and 2009 and thereafter enrolled in supportive peri-implant treatment (SPT)

You may qualify if:

  • \- All patients treated with peri-implantitis surgery between 2007 and 2009 using an anti-infective protocol.

You may not qualify if:

  • Patients treated with peri-implantitis surgery between 2007 and 2009 using a regenerative protocol at one single implants with peri-implantitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giovanni Serino

Borås, 50182, Sweden

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • Roccuzzo M, Layton DM, Roccuzzo A, Heitz-Mayfield LJ. Clinical outcomes of peri-implantitis treatment and supportive care: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:331-350. doi: 10.1111/clr.13287.

  • Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

  • Lagervall M, Jansson LE. Treatment outcome in patients with peri-implantitis in a periodontal clinic: a retrospective study. J Periodontol. 2013 Oct;84(10):1365-73. doi: 10.1902/jop.2012.120555. Epub 2012 Dec 13.

  • Pjetursson BE, Helbling C, Weber HP, Matuliene G, Salvi GE, Bragger U, Schmidlin K, Zwahlen M, Lang NP. Peri-implantitis susceptibility as it relates to periodontal therapy and supportive care. Clin Oral Implants Res. 2012 Jul;23(7):888-94. doi: 10.1111/j.1600-0501.2012.02474.x. Epub 2012 Apr 24.

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Giovanni Serino, DDS PhD

    Folktanvarden Specilist Clinic Periodntology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Periodontology

Study Record Dates

First Submitted

January 24, 2020

First Posted

February 5, 2020

Study Start

January 1, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

After publication, on request, summary data

Locations