NCT03485664

Brief Summary

This prospective study was performed on 82 participants. Severe pain on percussion of the relevant tooth was considered as basic criteria when deciding on acute infection phase. The acutely infected teeth were labeled as the study group (n=35) and the asymptomatic ones as the control group (n=47). The extractions were done in the usual way. Amount of anesthetic solution used and durations of extractions were recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

March 23, 2018

Last Update Submit

March 31, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • diagnosis of alveolaris osteitis

    1-4 days

  • diagnosis of systemic response

    1-7 days

Study Arms (2)

Study Group

Severe pain on percussion of the relevant tooth was considered as basic criteria when deciding on acute infection phase. The acutely infected teeth were labelled as the study group

Procedure: tooth extraction

Control Group

The asymptomatic teeth were labelled as the control group

Procedure: tooth extraction

Interventions

tooth extraction

Control GroupStudy Group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients were selected among medically healthy volunteers, who referred to the investigators for extraction only one mandibular molar tooth. The informed consents were obtained. Exclusion criteria were smoking, oral contraceptive use, any conditions affecting the immune system, usage of antibiotics in last two weeks and the teeth needed surgical extractions. percussion sensitivity is used as separator between two groups.

You may qualify if:

  • indication for only one mandibular molar tooth extraction (severe pain on percussion labeled as the study group and asymptomatic ones labeled as the control group)

You may not qualify if:

  • smoking, oral contraceptive use, any conditions affecting the immune system, usage of antibiotics in last two weeks the teeth needed surgical extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University, Faculty of dentistry

Konya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Dilek Menziletoğlu

    Academic Member

    STUDY DIRECTOR
  • Bozkurt Kubilay Işık

    Concultant

    STUDY CHAIR
  • Gökhan Gürses

    Care Provider

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 2, 2018

Study Start

February 15, 2017

Primary Completion

January 15, 2018

Study Completion

March 15, 2018

Last Updated

April 3, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

A total of 82 patients aged between 15 and 79 years (mean 40.52 ± 15.46) met the study criteria. When deciding on acute infection phase, percussion sensitivity was accepted as the basic criteria. It was defined as severe pain when a dental mirror was dropped about 1 cm above the tooth. Patients with acutely infected teeth were labelled as "study group" (n = 35) and the asymptomatic patients as "control group" (n = 47). Null hypothesis of the study was "there is no significant difference between the acutely infected and asymptomatic lower molar teeth in terms of the complications that may occur during and after tooth extraction". The level of statistical significance was accepted as 0.05 and SigmaPlot 11.0 program was used for statistical analyses.

Locations