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NCT Number: NCT03611920

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

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.

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Key information

Conditions

Dental Trauma Avulsion Fractures, Avulsion Fractures, Bone Periodontal Regeneration Pulpal Regeneration Topical Dexamethasone Topical Tetracycline Wounds and Injuries

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

zmk Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Avulsion of a permanent tooth
  • Written informed consent

Exclusion criteria

  • Extended dry period of more than 60 minutes

Treatment and study plan

Tetracycline

Procedure

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

Dexamethasone

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Number of teeth that survived

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

    Assessed by visual inspection

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

    Time frame: At baseline

    Assessed by x-ray

  3. Patients satisfaction

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

    Measured by OHIP-14 score

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2018
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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