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CompletedNCT03611920Updated Aug 21, 2018

Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Teeth

An observational study in Dental Trauma, Avulsion and Periodontal Regeneration, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2018-08-21.

Sponsored by University of Bern · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
33
Ages
6 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dental Trauma
  • Avulsion
  • Periodontal Regeneration
  • Pulpal Regeneration
  • Topical Dexamethasone
  • Topical Tetracycline

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03

In context

Fractures, Avulsion

16 studies on the registry are indexed under Fractures, Avulsion; 4 are open to participants now.

Browse Fractures, Avulsion studies →

Lead sponsor

University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with avulsed permanent teeth who were treated between 2000-2008 at the Department of Oral Surgery, zmk Bern

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Avulsion of a permanent tooth
  • Written

Exclusion criteria

Exclusion Criteria:

  • Extended dry period of more than 60 minutes
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
33 participants (actual)
Patient registry
No

Groups and cohorts

  • Tetracycline

    Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation

    Procedure: Tetracycline

  • Dexamethasone

    Teeth were soaked in dexamethasone (60μ ml-1) for 20 minutes before replantation

    Procedure: Dexamethasone

Interventions

  • ProcedureTetracycline

    Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation

  • ProcedureDexamethasone

    Teeth were soaked in topical dexamethasone (60μ ml-1) for 20 minutes before replantation

06

What researchers measure

Primary outcomes

  1. Number of teeth with periodontal regeneration

    Periodontal regeneration was assessed with periodontal examination, percussion, Periotest measurements and periapical radiograph.

    Time frame: After a mean observation period of 12.9±2.4 years (one visit only)

  2. Number of teeth with pulpal regeneration

    Pulpal regeneration was assessed with periodontal examination, percussion, Periotest measurements, pulp sensitivity using CO2 snow and periapical radiograph.

    Time frame: After a mean observation period of 12.9±2.4 years (one visit only)

Secondary outcomes

  1. Number of teeth that survived

    Assessed by visual inspection

    Time frame: After a mean observation period of 12.9±2.4 years (one visit only)

  2. Number of teeth with open versus closed apex at accident

    Assessed by x-ray

    Time frame: At baseline

  3. Patients satisfaction

    Measured by OHIP-14 score

    Time frame: After a mean observation period of 12.9±2.4 years (one visit only)

07

Study locations

1 site
  • zmk Bern
    Bern, 3010, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2000 to primary completion in Oct 2017, 205 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2018
First posted
Aug 2, 2018
StartActual
Aug 14, 2000
Primary completionActual
Oct 5, 2017
CompletionActual
Oct 5, 2017
Last update
Aug 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03611920
Lead sponsor
University of Bern
Responsible party
Sponsor
First posted
Aug 2, 2018
Start date
Aug 14, 2000
Primary completion
Oct 5, 2017
Completion
Oct 5, 2017
Last update
Aug 21, 2018

Study contacts

Vivianne Chappuis, PD Dr.
study chair · Department of Oral Surgery and Stomatology, zmk Bern, University Bern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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