NCT02235220

Brief Summary

In this study it is to be evaluated wether a restoration with composite resin fillings to reestablish a canine guidance will reduce masticatory muscle activity in patients with bruxism.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 26, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

September 4, 2014

Last Update Submit

September 25, 2014

Conditions

BruxismMyopathyMuscular Activity

Keywords

Bruxism

Outcome Measures

Primary Outcomes (1)

  • Reduction of masticatory muscular activity

    Masticatory muscular activity is measured before and after treatment with additive composite resin fillings (Tetric EvoCeram, Ivoclar Vivadent, Schaan, Liechtenstein). A Grindcare (Medotech A/S, Herlev, Denmark) device is used for determination of muscular activity.

    13 weeks

Study Arms (1)

Composite resin restoration

EXPERIMENTAL

A canine guidance is reestablished by additive composite resin restorations of the canine cusp.

Other: Composite resin restoration

Interventions

Composite resin restorationOTHER

Masticatory muscular activity is measured before and after treatment with additive composite resin fillings (Tetric EvoCeram, Ivoclar Vivadent, Schaan, Liechtenstein). A Grindcare (Medotech A/S, Herlev, Denmark) device is used for determination of muscular activity. A first measurement is conducted, followed by 4 weeks without any intervention. A second measurement is then carried out before restoration of the canine cusps with composite fillings. A third measurement is conducted, again followed by 4 weeks without any intervention. At last a final measurement is conducted.

Composite resin restoration

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients show signs of bruxism
  • no canine guidance is present
  • no prosthodontic restorations of the canine are present

You may not qualify if:

  • a sufficient canine guidance is present

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BruxismMuscular Diseases

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Matthias Kern, DDS, PhD

    University of Kiel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Martin Sasse, D.M.D, Assistant Professor

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 9, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

September 26, 2014

Record last verified: 2014-09