Dental TraumaNCT03611920
Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Teeth
An observational study of Dental Trauma and Avulsion, run by University of Bern at 1 site in Switzerland.
Trial summary
To evaluate the effect of topical tetracycline and dexamethasone on periodontal and pulpal regeneration of avulsed permanent teeth after an observation period between 9-16 years. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Dental Trauma, Avulsion, Periodontal Regeneration
- What is being tested?
- Tetracycline and Dexamethasone
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Aug 2000to 5 Oct 2017
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with avulsed permanent teeth who were treated between 2000-2008 at the Department of Oral Surgery, zmk Bern
Who may be able to join
- Avulsion of a permanent tooth
- Written informed consent
Who cannot join
- Extended dry period of more than 60 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Permanent Teeth: A Long-term Follow-up After 9-16 Years
To evaluate the effect of topical tetracycline and dexamethasone on periodontal and pulpal regeneration of avulsed permanent teeth after an observation period between 9-16 years.
Read the detailed description
Two different medications were applied prior to replantation. A) Topical tetracycline, B) topical dexamethasone. Teeth were splinted using a non-rigid titanium trauma splint for 7-14 days. Endodontic treatment was performed within 1-7 days, except for teeth with an open apex and a short extraoral dry time. All patients received systemic tetracycline for 10 days after accident and were subsequently re-examined.
Follow-up examinations included periodontal examination, percussion, Periotest measurements, pulp sensitivity using CO2 snow, periapical radiograph and intraoral photographs. Additionally a OHIP-14 questionnaire was carried out to determine the oral health-related quality of life.
- Conditions
- Dental Trauma, Avulsion, Periodontal Regeneration, Pulpal Regeneration, Topical Dexamethasone, Topical Tetracycline
- Being tested
- Tetracycline, Dexamethasone
- Medical subject headings
- Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracyclineProcedure or surgery
Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation
DexamethasoneProcedure or surgery
Teeth were soaked in topical dexamethasone (60μ ml-1) for 20 minutes before replantation
| Study group | Role | What they receive |
|---|---|---|
| Tetracycline | Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation Receives: Procedure: Tetracycline | |
| Dexamethasone | Teeth were soaked in dexamethasone (60μ ml-1) for 20 minutes before replantation Receives: Procedure: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of teeth with periodontal regeneration
Periodontal regeneration was assessed with periodontal examination, percussion, Periotest measurements and periapical radiograph.
Measured: After a mean observation period of 12.9±2.4 years (one visit only)
Number of teeth with pulpal regeneration
Pulpal regeneration was assessed with periodontal examination, percussion, Periotest measurements, pulp sensitivity using CO2 snow and periapical radiograph.
Measured: After a mean observation period of 12.9±2.4 years (one visit only)
Secondary outcomes (3)
Number of teeth that survived
Assessed by visual inspection
Measured: After a mean observation period of 12.9±2.4 years (one visit only)
Number of teeth with open versus closed apex at accident
Assessed by x-ray
Measured: At baseline
Patients satisfaction
Measured by OHIP-14 score
Measured: After a mean observation period of 12.9±2.4 years (one visit only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start14 Aug 2000
- Primary completion5 Oct 2017
- Study completion5 Oct 2017
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 BernThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivianne Chappuis, PD Dr., Study chair, Department of Oral Surgery and Stomatology, zmk Bern, University Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611920
- Sponsor's protocol ID
- KEK: 2016-00383
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Permanent Teeth: A Long-term Follow-up After 9-16 Years
- ClinicalTrials.gov ID
- NCT03611920
- Acronym / sponsor ID
- KEK: 2016-00383
- Conditions
- Dental Trauma, Avulsion, Periodontal Regeneration, Pulpal Regeneration, Topical Dexamethasone, Topical Tetracycline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 14 Aug 2000 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 2 Aug 2018 (actual)
- 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.
To evaluate the effect of topical tetracycline and dexamethasone on periodontal and pulpal regeneration of avulsed permanent teeth after an observation period between 9-16 years.
Detailed description
Two different medications were applied prior to replantation. A) Topical tetracycline, B) topical dexamethasone. Teeth were splinted using a non-rigid titanium trauma splint for 7-14 days. Endodontic treatment was performed within 1-7 days, except for teeth with an open apex and a short extraoral dry time. All patients received systemic tetracycline for 10 days after accident and were subsequently re-examined.
Follow-up examinations included periodontal examination, percussion, Periotest measurements, pulp sensitivity using CO2 snow, periapical radiograph and intraoral photographs. Additionally a OHIP-14 questionnaire was carried out to determine the oral health-related quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetracycline | – | Procedure: TetracyclineTeeth were soaked in topical tetracycline 5% for 5 minutes before replantation |
| Dexamethasone | – | Procedure: DexamethasoneTeeth were soaked in dexamethasone (60μ ml-1) for 20 minutes before replantation |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with avulsed permanent teeth who were treated between 2000-2008 at the Department of Oral Surgery, zmk Bern
Key inclusion criteria (2 listed)
- Avulsion of a permanent tooth
- Written informed consent
Key exclusion criteria (1 listed)
- Extended dry period of more than 60 minutes
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 |
|---|---|---|
| TetracyclineTeeth were soaked in topical tetracycline 5% for 5 minutes before replantation | Procedure or surgery | Tetracycline |
| DexamethasoneTeeth were soaked in topical dexamethasone (60μ ml-1) for 20 minutes before replantation | Procedure or surgery | Dexamethasone |
Primary outcome
Number of teeth with periodontal regeneration
Time frame: After a mean observation period of 12.9±2.4 years (one visit only)
Periodontal regeneration was assessed with periodontal examination, percussion, Periotest measurements and periapical radiograph.
Number of teeth with pulpal regeneration
Time frame: After a mean observation period of 12.9±2.4 years (one visit only)
Pulpal regeneration was assessed with periodontal examination, percussion, Periotest measurements, pulp sensitivity using CO2 snow and periapical radiograph.
3 secondary outcomes
Number of teeth that survived
Time frame: After a mean observation period of 12.9±2.4 years (one visit only)
Number of teeth with open versus closed apex at accident
Time frame: At baseline
Patients satisfaction
Time frame: After a mean observation period of 12.9±2.4 years (one visit only)
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 21 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Vivianne Chappuis, PD Dr. study chair
Department of Oral Surgery and Stomatology, zmk Bern, University Bern
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 and Avulsion, run by University of Bern at 1 site in Switzerland.
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 1 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 21 Aug 2018. 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 Switzerland. 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.
What does the primary outcome measure?
Number of teeth with periodontal regeneration (time frame: After a mean observation period of 12.9±2.4 years (one visit only)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 21 Aug 2018.