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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Trauma; Avulsion; Periodontal Regeneration; Pulpal Regeneration; Topical Dexamethasone; Topical Tetracycline
• Intervention / Treatment: Procedure: Tetracycline; Procedure: Dexamethasone

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 Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • zmk Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• Avulsion of a permanent tooth
• Written informed consent

Exclusion Criteria:

• Extended dry period of more than 60 minutes

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tetracycline; Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation	Procedure: Tetracycline; Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation
Dexamethasone; Teeth were soaked in dexamethasone (60μ ml-1) for 20 minutes before replantation	Procedure: Dexamethasone; Teeth were soaked in topical dexamethasone (60μ ml-1) for 20 minutes before replantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Study Chair: Vivianne Chappuis, PD Dr., Department of Oral Surgery and Stomatology, zmk Bern, University Bern

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2000
• Primary Completion (Actual): October 5, 2017
• Study Completion (Actual): October 5, 2017

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Avulsion; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Dexamethasone; Tetracycline
• Other Study ID Numbers: KEK: 2016-00383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No