Sleep Bruxism and (Peri-)Implant Complications

• ClinicalTrials.gov Identifier: NCT02410681
• Recruitment Status: Completed
• First Posted: April 8, 2015
• Last Update Posted: July 10, 2019
• Sponsor: Frank Lobbezoo
• Information provided by (Responsible Party): Frank Lobbezoo, Academic Centre for Dentistry in Amsterdam

Study Description

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.

Condition or disease	Intervention/treatment
Dental Implant Complications; Sleep Bruxism	Device: Electromyographic recording of temporalis muscle activity during sleep; Radiation: Vertical bitewing radiograph; Other: Collection of biofilm sample

Study Design

• Study Type: Observational
• Actual Enrollment: 11 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Associations Between Sleep Bruxism and (Peri-)Implant Complications: a Follow-up Study
• Study Start Date: March 2015
• Actual Primary Completion Date: May 2019
• Actual Study Completion Date: May 2019

Groups and Cohorts

Intervention Details:

• 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.

  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
• 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:

  1. At the baseline visit
  2. Three months after the baseline visit
  3. One year after the baseline visit

Outcome Measures

Primary Outcome Measures :

1. 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. ]
2. 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. ]
3. 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. ]
4. 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. ]
5. Occurrence and type of implant technical complications, assessed by clinical examination. [ Time Frame: Six weeks, three months, one year, two years. ]
6. 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. ]

Biospecimen Retention:   Samples With DNA

Peri-implant intrasulcular biofilm.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Locations

Netherlands

Academic Centre for Dentistry Amsterdam (ACTA)

Amsterdam, Netherlands, 1081 LA

Sponsors and Collaborators

Frank Lobbezoo

Investigators

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

More Information

• Responsible Party: Frank Lobbezoo, Prof. Dr., Academic Centre for Dentistry in Amsterdam
• ClinicalTrials.gov Identifier: NCT02410681 History of Changes
• Other Study ID Numbers: ACTA_2012-2015
• First Posted: April 8, 2015
• Last Update Posted: July 10, 2019
• Last Verified: July 2019

Additional relevant MeSH terms:

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