The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patients With Mild Pericoronitis

February 13, 2017 updated by: Cahit UCOK, Ankara University

The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patints With Mild Pericoronitis

The complications that could occur during or after the extraction of the mandibular third molar teeth with pericoronitis affect patient's life quality considerably. Various scales are used to reveal how much the life quality of patients is affected this treatment. The aim of this study is to identify the long term life quality of patients through the OHIP-14 TR scale without removing the mandibular third molar teeth with mild pericoronitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Increasing the lenght stay in the mouth at a maximum rate and following the patient up after the necessary treatment and information procedures are completed. As a result of clinical and radiographical examinations fifty-five voluntary patients whose average age was 24 and who have semi or fully errupted vertical mandibular third molar teeth with the diagnosis of mild pericoronitis were included in the study.After the patients in the study filled out the form including their contact and demographic data and dental symptomsand completed OHIP-14 TR scale which last about 5 minutes, their curretage and operculectomy treatments were done under local anesthesia. The patients were invited for reexamination on seventh day after the treatment. Also, an active patient follow up about life quality was performed by phone at 1,3,6 month after the treatment using the self -assessment question form and the OHIP-14 TR scale.

Study Type

Observational

Enrollment (Actual)

55

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

55 patients diagnosed with pericoronitis affecting third molars

Description

Inclusion Criteria:

  • having the first episode of mild pericoronitis, having a good periodontal health, having an age between 18 and 25 years
  • having a diagnosis of pericoronitis of a vertically erupted or semi erupted lower third molar, having no systemic discomfort and being in the ASA I and ASAII

Exclusion Criteria:

  • having no lower third molar with a vertical position
  • having a systemic discomfort
  • having moderate to severe pericoronitis
  • having a history antibiotics or NSAIID

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
long term quality of life
to evaluate conservatively managed third molars with mild pericoronitis at first, third and sixth months by using OHIP-14 TR
Behavioral: quality of life in the patients with mild pericoronitis
active surviallence by OHIP-14 TR after treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total score of OHIP-14 TR at the begining of experiment
Time Frame: first month
numeric values of OHIP-14 TR
first month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total score of OHIP-14 TR at third months
Time Frame: third months
numeric values of OHIP-14 TR
third months
Total score of OHIP-14 TR at sixth months
Time Frame: sixth months
numeric values of OHIP-14 TR
sixth months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (ESTIMATE)

January 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/5-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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