Dental Implant ComplicationsNCT02410681
Sleep Bruxism and (Peri-)Implant Complications
An observational study of Dental Implant Complications and Sleep Bruxism, run by Frank Lobbezoo at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant Complications, Sleep Bruxism
- What is being tested?
- Electromyographic recording of temporalis muscle activity during sleep, Vertical bitewing radiograph and Collection of biofilm sample
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with implant-supported fixed suprastructure(s), age 18 years or older.
Who may be able to join
- Planned for treatment with implant-supported fixed suprastructure(s).
- 18 years of age or older.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Centre for Dentistry Amsterdam (ACTA)
Amsterdam, 1081 LA
About this study
Official title: 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.
- Conditions
- Dental Implant Complications, Sleep Bruxism
- Being tested
- Electromyographic recording of temporalis muscle activity during sleep, Vertical bitewing radiograph, Collection of biofilm sample
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyographic recording of temporalis muscle activity during sleepDevice
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
Vertical bitewing radiographRadiation
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 sampleOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of peri-implant marginal bone loss (in mm) during a two-year follow-up period, assessed by intraoral radiographs.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, two weeks, six weeks, three months, one year, two years.
Occurrence and type of implant technical complications, assessed by clinical examination.
Measured: 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.
Measured: Baseline, two weeks, six weeks, three months, one year, two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank Lobbezoo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frank Lobbezoo, Academic Centre for Dentistry in Amsterdam
- Investigators
- Frank Lobbezoo, Prof. Dr., Principal investigator, Academic Centre for Dentistry Amsterdam (ACTA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410681
- Sponsor's protocol ID
- ACTA_2012-2015
- Status last verified
- Jul 2019
- First submitted
- 26 Mar 2015
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Sleep Bruxism and (Peri-)Implant Complications: a Follow-up Study
- ClinicalTrials.gov ID
- NCT02410681
- Acronym / sponsor ID
- ACTA_2012-2015
- Conditions
- Dental Implant Complications, Sleep Bruxism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Frank LobbezooUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with implant-supported fixed suprastructure(s), age 18 years or older.
Key inclusion criteria (2 listed)
- Planned for treatment with implant-supported fixed suprastructure(s).
- 18 years of age or older.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyographic recording of temporalis muscle activity during sleepElectromyographic 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 | Device | – |
| Vertical bitewing radiographAn 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). | Radiation | – |
| Collection of biofilm sampleCollection 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 | Other | – |
Primary outcome
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.
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.
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.
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.
Occurrence and type of implant technical complications, assessed by clinical examination.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Lobbezoo, Prof. Dr. principal investigator
Academic Centre for Dentistry Amsterdam (ACTA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant Complications and Sleep Bruxism, run by Frank Lobbezoo at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.