Sleep Bruxism and (Peri-)Implant Complications

NCT02410681 | Completed DMC

• 1 other identifier: ACTA_2012-2015
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant Complications; Sleep Bruxism

Outcome Measures

Primary Outcomes (6)

• Progression of peri-implant marginal bone loss (in mm) during a two-year follow-up period, assessed by intraoral radiographs.

  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.

  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.

  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.

  Baseline, two weeks, six weeks, three months, one year, two years.

• Occurrence and type of implant technical complications, assessed by clinical examination.

  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.

  Baseline, two weeks, six weeks, three months, one year, two years.

Interventions

Electromyographic recording of temporalis muscle activity during sleep DEVICE

Electromyographic recording of temporalis muscle activity during sleep. In total, 9 sleep recordings will be done at the home setting of each participant. 1. 3 recordings after the baseline visit 2. 3 recordings 6 weeks after the baseline visit 3. 3 recordings one year after the baseline visit

Vertical bitewing radiograph RADIATION

An intraoral vertical bitewing radiograph will be performed with the assistance of individually modified plate positioning devices at each visit (in total 8 visits during the 2-year follow-up period).

Collection of biofilm sample OTHER

Collection of peri-implant intrasulcular biofilm sample for DNA analysis of the biofilm composition. In total, samples will be collected three times: 1. At the baseline visit 2. Three months after the baseline visit 3. One year after the baseline visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frank Lobbezoo: lead

Study Sites (1)

Academic Centre for Dentistry Amsterdam (ACTA)

Amsterdam, 1081 LA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peri-implant intrasulcular biofilm.

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Frank Lobbezoo, Prof. Dr.

  Academic Centre for Dentistry Amsterdam (ACTA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 8, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

NL (1)