NCT04024644

Brief Summary

Caries and periodontal disease are chronic diseases of the oral cavity. The incidence of caries and periodontal disease can vary depending on the position of the third molar, The aim of this study was to verify possible associations between oral health-related quality of life (QoL), periodontal disease, caries lesions and the position of the lower third molar.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

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

May 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

July 13, 2019

Last Update Submit

July 16, 2019

Conditions

Keywords

third molardental cariesperiodontal diseasequality of life

Outcome Measures

Primary Outcomes (1)

  • Caries

    Caries were assessed by visual tactile examination, only on occlusal surface in erupted or partially erupted third molars (visual tactile examination) and evaluation of the presence of the image on the panoramic radiograph.

    throughout study completion on average of one year

Secondary Outcomes (3)

  • periodontal disease

    throughout study completion on average of one year

  • Position of the lower third molars

    throughout study completion on average of one year

  • Oral health related quality of life: Brazilian version of OHIP-14 questionnaire

    throughout study completion on average of one year

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants with at least one third molar erupted or partially erupted. , regardless of age, gender, cultural level or socioeconomic status could participate in the study.

You may qualify if:

  • American society of anesthesiology (ASA) I patients (negative medical history)
  • with at least one third molar erupted or partially erupted

You may not qualify if:

  • systemically compromised
  • allergic
  • pregnants
  • patients who had the four third molars included
  • patients who have already undergone the extraction of one of the third molars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontal DiseasesDental Caries

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DemineralizationTooth Diseases

Study Officials

  • Waldyr A. Jorge

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, clinical professor

Study Record Dates

First Submitted

July 13, 2019

First Posted

July 18, 2019

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

May 1, 2014

Last Updated

July 18, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (10.1016/j.joms.2011.09.034)Access
Clinical Study Report (10.1016/j.joms.2011.09.034)Access