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Trial record 4 of 151 for:    tetracycline

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

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ClinicalTrials.gov Identifier: NCT03611920
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Dental Trauma Avulsion Periodontal Regeneration Pulpal Regeneration Topical Dexamethasone Topical Tetracycline 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.


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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : August 14, 2000
Actual Primary Completion Date : October 5, 2017
Actual Study Completion Date : October 5, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Avulsion of a permanent tooth
  • Written informed consent

Exclusion Criteria:

  • Extended dry period of more than 60 minutes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611920


Locations
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Switzerland
zmk Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Investigators
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Study Chair: Vivianne Chappuis, PD Dr. Department of Oral Surgery and Stomatology, zmk Bern, University Bern

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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03611920     History of Changes
Other Study ID Numbers: KEK: 2016-00383
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Tetracycline
Fractures, Avulsion
Fractures, Bone
Wounds and Injuries
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors