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A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery

A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03494972
Acronym
Wisdomsteeth
Enrollment
200
Registered
2018-04-11
Start date
2016-01-02
Completion date
2018-02-01
Last updated
2018-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Operative Wound Infection

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.

Interventions

DRUGTetracyclin ointment

During 3rd molar surgery

Sponsors

University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Alveolar ostitisOne weekRegistration of pain

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026