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

NCT03611920 | Completed

• 1 other identifier: KEK: 2016-00383
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of teeth with periodontal regeneration

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

  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.

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

Secondary Outcomes (3)

• Number of teeth that survived

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

• Number of teeth with open versus closed apex at accident

  At baseline

• Patients satisfaction

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

Study Arms (2)

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

Tetracycline PROCEDURE

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

Tetracycline

Dexamethasone PROCEDURE

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

Dexamethasone

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Avulsion of a permanent tooth
• Written informed consent

You may not qualify if:

• Extended dry period of more than 60 minutes

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

zmk Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Fractures, Avulsion

Interventions

Tetracycline; Dexamethasone

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Vivianne Chappuis, PD Dr.

  Department of Oral Surgery and Stomatology, zmk Bern, University Bern

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: August 14, 2000
• Primary Completion: October 5, 2017
• Study Completion: October 5, 2017
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)