NCT03494972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

April 4, 2018

Last Update Submit

April 4, 2018

Conditions

Post-Operative Wound Infection

Outcome Measures

Primary Outcomes (1)

  • Alveolar ostitis

    Registration of pain

    One week

Study Arms (2)

drain

ACTIVE COMPARATOR

Tetracyclin drain

Drug: Tetracyclin ointment

No-drain

SHAM COMPARATOR

No drain

Drug: Tetracyclin ointment

Interventions

Tetracyclin ointmentDRUG

During 3rd molar surgery

No-draindrain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tore Bjornland

Oslo, 0317, Norway

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tore Bjornland, PhD

    Chair Dep oral Surgery and Oral Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 11, 2018

Study Start

January 2, 2016

Primary Completion

March 1, 2017

Study Completion

February 1, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

NO(1)