Dental TraumaNCT00904930
Evaluation of the Periotest Method in Dental Traumatology
An observational study of Dental Trauma, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 36 years
- Conditions the study is for
- Dental Trauma
- What is being tested?
- Wire Composite Splint (Dentaflex 0.45 mm) and Wire Composite Splint (Denture Strengtheners)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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 19 to 36 years
- All sexes
- Adult
Study population: Dental students Dental Clinic 1 and 2
Who may be able to join
- age 19-36
- healthy upper front teeth
Who cannot join
- periodontal disease
- orthodontic treatment during the investigation period
- history of dental trauma
- fillings or restorations on upper front teeth
- endodontically treated teeth
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, Bavaria, 91054
About this study
Official title: Evaluation of the Periotest Method as a Tool for Tooth Mobility Monitoring and Splint Rigidity Assessment in Dental Traumatology
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).
- Conditions
- Dental Trauma
- Being tested
- Wire Composite Splint (Dentaflex 0.45 mm), Wire Composite Splint (Denture Strengtheners)
- Keywords
- Tooth mobility assessment, Splinting, Splint Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wire Composite Splint (Dentaflex 0.45 mm)Device
Wire-Composite-Splint: Dentaflex 0.45 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow (IvoclarVivadent, Schaadn, Liechtenstein) to the teeth
Wire Composite Splint (Denture Strengtheners)Device
Wire-Composite-Splint: Denture Strengtheners 0.8x1.8 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow to the teeth
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Wire Composite Splint (Dentaflex 0.45 mm); Device: Wire Composite Splint (Denture Strengtheners) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental TraumaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904930
- Sponsor's protocol ID
- PT-WCS1-WCS2-Hu
- Status last verified
- Dec 2020
- First submitted
- 19 May 2009
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Periotest Method as a Tool for Tooth Mobility Monitoring and Splint Rigidity Assessment in Dental Traumatology
- ClinicalTrials.gov ID
- NCT00904930
- Acronym / sponsor ID
- PT-WCS1-WCS2-Hu
- Conditions
- Dental Trauma
- Keywords
- Tooth mobility assessment, Splinting, Splint Rigidity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- First posted
- 20 May 2009 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no periodontal disease | – | Device: Wire Composite Splint (Dentaflex 0.45 mm), Device: Wire Composite Splint (Denture Strengtheners)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 |
Who may qualify
- Ages
- 19 to 36 years
- Sex
- All
- Age groups
- Adult
- Study population
- Dental students Dental Clinic 1 and 2
Key inclusion criteria (2 listed)
- age 19-36
- healthy upper front teeth
Key exclusion criteria (5 listed)
- periodontal disease
- orthodontic treatment during the investigation period
- history of dental trauma
- fillings or restorations on upper front teeth
- endodontically treated teeth
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 |
|---|---|---|
| Wire Composite Splint (Dentaflex 0.45 mm)Wire-Composite-Splint: Dentaflex 0.45 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow (IvoclarVivadent, Schaadn, Liechtenstein) to the teeth | Device | no periodontal disease |
| Wire Composite Splint (Denture Strengtheners)Wire-Composite-Splint: Denture Strengtheners 0.8x1.8 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow to the teeth | Device | no periodontal disease |
Primary outcome
Not reported in the source record.
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 14 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Trauma, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 5 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 14 Dec 2020. 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 Germany. 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.
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 14 Dec 2020.