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Trial record 3 of 150 for:    tetracycline

A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery (Wisdomsteeth)

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ClinicalTrials.gov Identifier: NCT03494972
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tore Bjornland, University of Oslo

Brief Summary:
The aim of this study was to investigate the effect of an oxytetracycline impregnated gauze drain on the incidence of alveolar osteitis (AO) and postoperative pain during the first week after mandibular third molar surgery.

Condition or disease Intervention/treatment Phase
Post-Operative Wound Infection Drug: Tetracyclin ointment Not Applicable

Detailed Description:

The study was designed as a single-blinded randomized controlled trial. Patients were randomized in two groups by a sealed envelope system: a drain group and a control group. The study population comprised patients undergoing surgical removal of one or both mandibular third molars (3M) during January 2016 until March 2017. Patients referred to our department, who fulfilled the inclusion criteria, were asked to participate in the study. Patients were prospectively included after giving written informed consent.

The inclusion criteria were: age >18 years, indication for removal of one or both 3M, ASA I-II, no need for sedatives, possession of a smartphone with internet access (to be able to register pain score and use of analgesics, see "Data collection methods and statistical analysis"), and being able to attend a postoperative examination after 1 week. Exclusion criteria were: age <18 years, no indication for removal of 3M, ASA III or higher, pregnancy or breastfeeding, need for sedatives or systemic antibiotics, not possessing a smartphone, and not being able to attend a postoperative examination after 1 week. The National Institutes of Health's Consensus Statement (1979) and the American Association of Oral and Maxillofacial Surgeons White Paper on Third Molar Data (2007) served as guidelines when evaluating indication for 3M removal (NIH Consensus Statement 1979, AAOMS White Paper 2007).

Study population (n=200) and group size (n=100) were determined through power analysis: 90% power, 5% significance level and an expected difference of up to 10% between the two groups.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery
Actual Study Start Date : January 2, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: drain
Tetracyclin drain
Drug: Tetracyclin ointment
During 3rd molar surgery

Sham Comparator: No-drain
No drain
Drug: Tetracyclin ointment
During 3rd molar surgery




Primary Outcome Measures :
  1. Alveolar ostitis [ Time Frame: One week ]
    Registration of pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The inclusion criteria were: age >18 years, indication for removal of one or both 3M, ASA I-II, no need for sedatives, possession of a smartphone with internet access (to be able to register pain score and use of analgesics, see "Data collection methods and statistical analysis"), and being able to attend a postoperative examination after 1 week.

Exclusion Criteria:

Exclusion criteria were: age <18 years, no indication for removal of 3M, ASA III or higher, pregnancy or breastfeeding, need for sedatives or systemic antibiotics, not possessing a smartphone, and not being able to attend a postoperative examination after 1 week.


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): NCT03494972


Locations
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Norway
Tore Bjornland
Oslo, Norway, 0317
Sponsors and Collaborators
University of Oslo
Investigators
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Principal Investigator: Tore Bjornland, PhD Chair Dep oral Surgery and Oral Medicine

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Responsible Party: Tore Bjornland, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT03494972     History of Changes
Other Study ID Numbers: 2015/2168/REK sør-øst B
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tetracycline
Wound Infection
Surgical Wound Infection
Osteitis
Dry Socket
Surgical Wound
Infection
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action