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Peri-ImplantitisNCT04254406

Ten Years Follow up of Peri-implant Surgery

An observational study of Peri-Implantitis, run by Public Dental Service, Specialist Clinics, Sweden at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Peri-Implantitis
What is being tested?
Descriptive study
How many people
41 participants
Where
1 siteSweden
Study dates
1 Jan 2019to 1 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

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)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Giovanni Serino

    Borås, 50182

Other trials in Sweden

About this study

Official title: 10 Years Follow-up of Patients With Residual Pockets Following the Surgical Treatment of Peri-implantitis

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.

Read the detailed description

The data for this retrospective clinical evaluation were collected from the files and radiographs of consecutive patients who had received surgical treatment of peri-implantitis between 2007 and 2009 and thereafter enrolled in supportive peri-implant treatment (SPT) .

Between 2007 and 2009, 41 patients with at least 1 implant with peri-implantitis that underwent peri-implant surgery were enrolled in a supportive peri-implant therapy.

At the 2-years follow up, two groups could be identified, one "responding group" (17 patients) who did not present any implants with peri-implantitis and a "no-responding Group" (22 patients), presenting still peri-implantitis.

Following the 2-years control visit, 17 patients of the responding group exited the supporting peri-implant therapy at the specialist clinic. They continued the routine controls at their referral clinics while the 22 patients of the no-responding group, continued the scheduled supportive peri-implant therapy (SPT) given at the specialist clinic.

Being tested
Descriptive study
Keywords
Peri-Implantitis surgery, Treatment outcome, Risk factors
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Descriptive studyOther

    Evaluation of routine treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 years

  2. 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.

    Measured: 10 years

  3. 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

    Measured: 10 years

  4. 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

    Measured: 10 years

Secondary outcomes (1)

  1. Assessement of risk factors related to the persistence of peri-implantitis

    A univariate logistic regression to assess the correlations between each independent variable and the binary outcome presence or absence of peri-implantitis at treated implants will be used. Then, a multivariable regression analysis will be use including the independent variables from the univariate analysis that reach a statistical significance after adjusting for gender and age.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start1 Jan 2019
  3. Primary completion1 Oct 2019
  4. Study completion1 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04254406
Sponsor's protocol ID
PDSSweden
Status last verified
Feb 2020
First submitted
24 Jan 2020
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After publication, on request, summary data

Publications

  • 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.

    PubMed 27335316

  • 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.

    PubMed 24861154

  • 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.

    PubMed 21309860

  • 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.

    PubMed 30328195

  • 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.

    PubMed 29926491

  • 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.

    PubMed 23237584

  • 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.

    PubMed 22530771

Questions about this trial

What is this clinical trial studying?

An observational study of Peri-Implantitis, run by Public Dental Service, Specialist Clinics, Sweden at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number patients with persisting peri-implantitis following peri-implant surgery (time frame: 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04254406, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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