A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery

Post-Operative Wound Infection Clinical Trial

— Wisdomsteeth  

Official title:

A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494972
• Other study ID #: 2015/2168/REK sør-øst B
• Status: Completed
• Phase: N/A
• First received: April 4, 2018
• Last updated: April 4, 2018
• Start date: January 2, 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: April 2018
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 1, 2018
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Socket
• Osteitis
• Post-Operative Wound Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Drug:
• Tetracyclin ointment
During 3rd molar surgery

Locations

Country	Name	City	State
Norway	Tore Bjornland	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar ostitis	Registration of pain	One week