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

Dental Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611920
• Other study ID #: KEK: 2016-00383
• Status: Completed
• Start date: August 14, 2000
• Est. completion date: October 5, 2017

Study information

• Verified date: August 2018
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 5, 2017
• Est. primary completion date: October 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Avulsion of a permanent tooth

• Written informed consent

Exclusion Criteria:

• Extended dry period of more than 60 minutes

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Tetracycline
Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation
• Dexamethasone
Teeth were soaked in topical dexamethasone (60µ ml-1) for 20 minutes before replantation

Locations

Country	Name	City	State
Switzerland	zmk Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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