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

Primary Purpose

Post-Operative Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tetracyclin ointment
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-Operative Wound Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tore Bjornland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

drain

No-drain

Arm Description

Tetracyclin drain

No drain

Outcomes

Primary Outcome Measures

Alveolar ostitis
Registration of pain

Secondary Outcome Measures

Full Information

First Posted
April 4, 2018
Last Updated
April 4, 2018
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT03494972
Brief Title
A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery
Acronym
Wisdomsteeth
Official Title
A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2016 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Wound Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drain
Arm Type
Active Comparator
Arm Description
Tetracyclin drain
Arm Title
No-drain
Arm Type
Sham Comparator
Arm Description
No drain
Intervention Type
Drug
Intervention Name(s)
Tetracyclin ointment
Intervention Description
During 3rd molar surgery
Primary Outcome Measure Information:
Title
Alveolar ostitis
Description
Registration of pain
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore Bjornland, PhD
Organizational Affiliation
Chair Dep oral Surgery and Oral Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tore Bjornland
City
Oslo
ZIP/Postal Code
0317
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery

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