NCT06081816

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
5.1 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2019

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

June 11, 2019

Last Update Submit

October 7, 2023

Conditions

Keywords

molar third;dental cariesperiodontal diseasequality of life

Outcome Measures

Primary Outcomes (1)

  • carie

    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.

    one year

Secondary Outcomes (3)

  • Periodontal disease

    one year

  • Position of the lower third molars

    one year

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

    one year

Interventions

carieOTHER

Caries lesions were assessed by visual tactile examination and periodontal disease through two probing sites around third molar, considering the presence of periodontal pathology when at least one periodontal probing depth was greater than 4 mm, and both were evaluated by radiograph diagnostic methods. The assessment of oral health related quality of life by Oral Health impact Profile questionary (OHIP-14), applied as an interview. The evaluation of the position of the third molars was made by clinical and panoramic radiographs according to the classification of Pell and Gregory and Winter

Also known as: periodontal disease, health related quality of life, third molar position

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:

  • 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

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DemineralizationTooth Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Anna Carolina R Horliana, phd

    Nove de Julho University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd, clinical professor

Study Record Dates

First Submitted

June 11, 2019

First Posted

October 13, 2023

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

May 1, 2014

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report (10.4314/ahs.v19i1.55)Access
Study Protocol (10.1016/j.joms.2011.09.034)Access