Sleep Bruxism and (Peri-)Implant Complications

July 9, 2019 updated by: Frank Lobbezoo

Associations Between Sleep Bruxism and (Peri-)Implant Complications: a Follow-up Study

Excessive mechanical forces can cause complications of dental implants and their suprastructures (crowns and bridges), and can possibly be destructive for the bone and soft tissues around the implants. Sleep bruxism (grinding and clenching of the teeth during sleep) is considered as an important source of mechanical forces in the oral environment. Therefore, in this study, the investigators will investigate whether sleep bruxism is associated with implant and peri-implant complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081 LA
        • Academic Centre for Dentistry Amsterdam (ACTA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with implant-supported fixed suprastructure(s), age 18 years or older.

Description

Inclusion Criteria:

  • Planned for treatment with implant-supported fixed suprastructure(s).
  • 18 years of age or older.

Exclusion Criteria:

  • Opposing teeth of implant-supported fixed suprastructure(s) are restored with removable artificial teeth.
  • Patients categorized in the classes 3 or higher according to the ASA system for classification of physical status.
  • Use of occlusal splint, mandibular repositioning appliance or any other bruxism mitigating device during sleep.
  • Active periodontitis at the time of implant placement.
  • Known allergy to Grindcare® electrode material.
  • Patients with a pacemaker.
  • Swollen, infected or inflamed tissues or skin eruptions, e.g. phlebitis, varicose veins etc. in the placement area of the Grindcare® electrode.
  • Pregnant women will not be treated with dental implants. Pregnancy after placement of implants will not be a reason to stop participation of the subject in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression of peri-implant marginal bone loss (in mm) during a two-year follow-up period, assessed by intraoral radiographs.
Time Frame: Baseline, two weeks, six weeks, three months, one year, two years.
Baseline, two weeks, six weeks, three months, one year, two years.
Changes in the modified Gingival Index during a two-year follow-up period, assessed by probing.
Time Frame: Baseline, two weeks, six weeks, three months, one year, two years.
Baseline, two weeks, six weeks, three months, one year, two years.
Changes in the peri-implant clinical pocket depth (in mm) during a two-year follow-up period, assessed by probing.
Time Frame: Baseline, two weeks, six weeks, three months, one year, two years.
Baseline, two weeks, six weeks, three months, one year, two years.
Changes in implant mobility (mobility present or not) during a two-year follow-up period, assessed by clinical examination.
Time Frame: Baseline, two weeks, six weeks, three months, one year, two years.
Baseline, two weeks, six weeks, three months, one year, two years.
Occurrence and type of implant technical complications, assessed by clinical examination.
Time Frame: Six weeks, three months, one year, two years.
Six weeks, three months, one year, two years.
Changes in the peri-implant attachment level (in mm) during a two-year follow-up period, assessed by probing.
Time Frame: Baseline, two weeks, six weeks, three months, one year, two years.
Baseline, two weeks, six weeks, three months, one year, two years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frank Lobbezoo

Investigators

  • Principal Investigator: Frank Lobbezoo, Prof. Dr., Academic Centre for Dentistry Amsterdam (ACTA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTA_2012-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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