Sleep Bruxism and (Peri-)Implant Complications

Sleep Bruxism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410681
• Other study ID #: ACTA_2012-2015
• Status: Completed
• Start date: March 2015
• Est. completion date: May 2019

Study information

• Verified date: July 2019
• Source: Academic Centre for Dentistry in Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism
• Dental Implant Complications
• Sleep Bruxism

Intervention

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

Radiation:
• Vertical bitewing radiograph
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).

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

Locations

Country	Name	City	State
Netherlands	Academic Centre for Dentistry Amsterdam (ACTA)	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Frank Lobbezoo

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Occurrence and type of implant technical complications, assessed by clinical examination.		Six weeks, three months, one year, two years.
Primary	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.