Sleep Bruxism and (Peri-)Implant Complications

Completed

• Conditions: Sleep Bruxism; Dental Implant Complications

• Registration Number: NCT02410681
• Lead Sponsor: Frank Lobbezoo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-08
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Academic Centre for Dentistry Amsterdam (ACTA); 🇳🇱 Amsterdam, Netherlands