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Onderzoek naar relaties tussen nachtelijk knarsetanden en complicaties rond tandimplantaten.


- candidate number21175
- NTR NumberNTR4930
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-dec-2014
- Secondary IDsNL37715.029.11 ACTA_2012-2015
- Public TitleOnderzoek naar relaties tussen nachtelijk knarsetanden en complicaties rond tandimplantaten.
- Scientific TitleAssociations between sleep bruxism and (peri-)implant complications: a follow-up study.
- ACRONYM
- hypothesisExcessive mechanical load can cause complications of dental implants and their suprastructures, as well as the peri-implant soft and hard tissues. Sleep bruxism is considered as an important source of mechanical load in the oral environment. Therefore, it is hypothesized that sleep bruxism could be associated to implant and peri-implant complications.
- Healt Condition(s) or Problem(s) studiedImplants, Loss of osseointegration., marginal bone loss
- 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 9-jan-2015
- planned closingdate24-okt-2017
- Target number of participants100
- InterventionsPlacement of one or more dental implants which will support fixed suprastructures.
- Primary outcomePeri-implant inflammation and implant technical complications (modified gingival index, probing depth, implant mobility, marginal bone height, suprastructure complications, abutment complications, implant fracture, other complications)
- Secondary outcomeNone
- TimepointsExam 1: at appointment of impression for suprastructure
- Peri-implant conditions
- Oral hygiene
- Quality of plaque
- Occlusal force
- Awake bruxism
- Smoking
- Occluding pairs
- Indicators of parafunctions
-Periodontal parameters
-Sleep bruxism (3 nights)

Exam 2: at appointment of placing the suprastructure, 2 weeks after exam 1
- Peri-implant conditions
- Oral hygiene
- Occlusal force
- Prosthetic characteristics
- Opposing element characteristics
- Indicators of parafunctions
- Periodontal parameters

Exam 3: 4 weeks (+/- 3 days) after exam 2
- Peri-implant conditions
- Implant technical complications
- Sleep bruxism (3 nights)

Exam 4: 6 weeks (+/- 1 week) after exam 3
- Peri-implant conditions
- Implant technical complications
- Quality of plaque

Exam 5: 9 months (+/- 2 weeks) after exam 4
- Peri-implant conditions
- Oral hygiene
- Quality of plaque
- Awake bruxism
- Smoking
- Occluding pairs
- Opposing element chracteristics
- Implant technical complications
- Indicators of parafunctions
- Periodontal parameters
- Sleep bruxism (3 nights)

Exam 6: 6 months (+/- 3 weeks) after exam 7
- Peri-implant complications
- Implant technical complications
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESm. thymi@acta.nl Magdalini Thymi (PhD Student)
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Frank Lobbezoo
- Sponsor/Initiator Academic Center Dentistry Amsterdam (ACTA)
- Funding
(Source(s) of Monetary or Material Support)
Sunstar Suisse SA
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD18-dec-2014 - 27-jan-2016


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