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OpenTrials
Completed

NCT Number: NCT03494972

A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tore Bjornland

Oslo, 0317, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tetracyclin ointment

Drug

During 3rd molar surgery

Primary outcomes

  1. Alveolar ostitis

    Time frame: One week

    Registration of pain

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Acronym: Wisdomsteeth

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 11, 2018
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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