To investigate the time course in which (peri-)implant complications (i.e. inflammation and bone loss around dental implants and implant technical complications) develop and to identify the associations of sleep bruxism with these complications.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Prognosis for dental implant treatments.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peri-implant inflammation and bone loss.
Implant technical complications.
Secondary outcome
Not applicable.
Background summary
Prognosis for a dental implant treatment is evaluated in terms of technical and
biological aspects. Dental implant complications consist mainly of mechanical
complications related to implant components or suprastructures (i.e.,
artificial teeth on the implants) and biological complications related to
peri-implant mucosal or bone tissue. Clinical and radiographical evaluations of
the peri-implant tissue conditions are generally considered to be important for
detection of early signs of these implant complications.
Previous studies report that formation and development of a microbial biofilm
around an implant is an important etiologic factor in the pathogenesis of
peri-implant mucositis and peri-implantitis. Based on current literature, it is
unclear whether mechanical implant loading contributes to the peri-implant
tissue complications (i.e., inflammation and bone loss) due to the study
designs (retrospective cohort study) and/or lack of definition of loading
condition.
Sleep bruxism (SB), is defined as a repetitive jaw-muscle activity
characterized by clenching or grinding of the teeth and/or by bracing or
thrusting of the mandible during sleep. Most individuals have the manifestation
of the muscle activity, although it differs between individuals, i.e., some
individuals manifest more activities, than others.. Therefore, it should be
noted that virtually all individuals clench and/or grind during sleep with
individual variation. SB is considered to be an important source of loading
applied to implants. However, a relationship between SB and (peri-)implant
complications has not yet been demonstrated, which is partly because of the
large variation in the literature in terms of both the technical and the
biological aspects of implants and the suprastructures. Clearly, the
peri-implant complications (inflammation and bone loss) have a multifactorial
etiology and therefore, in this study, all etiological factors that have been
identified to date will be taken into account. SB will be monitored by
measuring masticatory muscle activity during sleep. As to avoid variation in
the outcomes caused by failing retention of removable suprastructures, we will
confine our study population to patients treated with fixed suprastructures.
Study objective
To investigate the time course in which (peri-)implant complications (i.e.
inflammation and bone loss around dental implants and implant technical
complications) develop and to identify the associations of sleep bruxism with
these complications.
Study design
Prospective cohort study.
Study burden and risks
Not applicable.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
Planned for treatment with implant-supported fixed suprastructure.
Exclusion criteria
Opposing teeth of implant-supported fixed suprastructure are restored with a removable denture.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT02410681 |
CCMO | NL37715.029.11 |
OMON | NL-OMON27266 |