NCT00904930

Brief Summary

Background/Aims: The Periotest® method represents a technique for objective tooth mobility assessment. The aims of this study were: 1. receiving information about normal Periotest® values in vertical and horizontal dimension on periodontally healthy teeth for individuals aged 20-35, 2. investigating the reliability of the Periotest® method in terms of intra-serial and inter-serial reproducibility before splinting and with an applied dental trauma splint, 3. evaluating the splint effect of two different wire-composite splints in vivo. Materials and Methods: On periodontally healthy dental students (n=33; mean age 24.7 years) Periotest® values were measured on reproducible measuring points, in vertical and horizontal dimension and before splinting and after splint insertion. Three readings were taken per serial to observe the intra-serial reproducibility, and for testing inter-serial reproducibility three serials were measured (Friedman-test; P ≤ 0.001). Two different wire-composite-splints (1 = Dentaflex 0.45 mm, 2 = Strengtheners 0.8x1.8) were inserted, the Periotest® values were measured and the splint effects were calculated and compared (Whitney-Mann-U-test; P ≤ 0.001).

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

First QC Date

May 19, 2009

Last Update Submit

December 10, 2020

Conditions

Keywords

Tooth mobility assessmentSplintingSplint Rigidity

Study Arms (1)

no periodontal disease

33 dental students (13 male, 20 female) with a mean age of 24.7 years (min. 19.8; max. 36.5) with no periodontal disease or dental trauma

Device: Wire Composite Splint (Dentaflex 0.45 mm)Device: Wire Composite Splint (Denture Strengtheners)

Interventions

Wire-Composite-Splint: Dentaflex 0.45 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow (IvoclarVivadent, Schaadn, Liechtenstein) to the teeth

no periodontal disease

Wire-Composite-Splint: Denture Strengtheners 0.8x1.8 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow to the teeth

no periodontal disease

Eligibility Criteria

Age19 Years - 36 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Dental students Dental Clinic 1 and 2

You may qualify if:

  • age 19-36
  • healthy upper front teeth

You may not qualify if:

  • periodontal disease
  • orthodontic treatment during the investigation period
  • history of dental trauma
  • fillings or restorations on upper front teeth
  • endodontically treated teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich-Alexander-University Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations