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

Completed

• Conditions: Avulsion; Periodontal Regeneration; Topical Dexamethasone; Dental Trauma; Pulpal Regeneration; Topical Tetracycline
• Interventions: Procedure: Tetracycline; Procedure: Dexamethasone

• Registration Number: NCT03611920
• Lead Sponsor: University of Bern

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.

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 Timeline

• Study Start: 2000-08-14
• Primary Completion: 2017-10-05
• Study Completion: 2017-10-05
• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-07-27
• Status Verified: 2018-08
• Study First Posted: 2018-08-02
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Avulsion of a permanent tooth
• Written informed consent

Exclusion Criteria

• Extended dry period of more than 60 minutes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tetracycline	Tetracycline	Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation
Dexamethasone	Dexamethasone	Teeth were soaked in dexamethasone (60μ ml-1) for 20 minutes before replantation

Primary Outcome Measures

Name	Time	Method
Number of teeth with periodontal regeneration	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	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 Outcome Measures

Name	Time	Method
Number of teeth that survived	After a mean observation period of 12.9±2.4 years (one visit only)	Assessed by visual inspection
Number of teeth with open versus closed apex at accident	At baseline	Assessed by x-ray
Patients satisfaction	After a mean observation period of 12.9±2.4 years (one visit only)	Measured by OHIP-14 score

Trial Locations

Locations (1)

zmk Bern; 🇨🇭 Bern, Switzerland