- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024644
Third Molar: Caries, Periodontal Disease and Quality of Life
July 16, 2019 updated by: Waldyr Antônio Jorge, University of Sao Paulo
Third Molar: Evaluation of Caries, Periodontal Disease and Quality of Life and Its Variation Concerning to Dental Position
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Caries and periodontal disease are chronic diseases of the oral cavity.
The presence of third molar teeth can lead to periodontal disease in the region, and often can lead to injuries and damage to the oral health, having a significant impact on the quality of life.
The incidence of caries and periodontal disease can vary depending on the position of the third molar.
Purpose: 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.
Materials and Methods: The investigators performed a clinical, observational cross-sectional study within 116 patients that were screened attending to evaluate the need for extraction of third molars at of the specialization course of Oral and Maxillofacial Surgery of Dental School Foundation of University of São Paulo (FFO-USP).
Caries, periodontal disease and quality of life are the outcomes that were evaluated by the main researcher.
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.
Data was treated and analyzed according to STATA 13.0, software with descriptive and inferential statistics.
The level of significance used was 95%.
The study had the approval of ethics committee from University of Sao Paulo Dental School (number 280084).
Study Type
Observational
Enrollment (Actual)
116
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
Inclusion Criteria:
- American society of anesthesiology (ASA) I patients (negative medical history)
- with at least one third molar erupted or partially erupted
Exclusion Criteria:
- 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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caries
Time Frame: throughout study completion on average of one year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
periodontal disease
Time Frame: throughout study completion on average of one year
|
Periodontal disease was assessed by gingival sulcus probing in the third molars at two points: mesiobuccal and distobuccal regions.
We considered the presence of Dp when the pocket was bigger than or equal to 4 mm.
|
throughout study completion on average of one year
|
Position of the lower third molars
Time Frame: throughout study completion on average of one year
|
Position of the lower third molars were assessed by panoramic radiography, according to the classification of Pell and Gregory and Winter, performed by only one evaluator, following the criteria of imaginary lines as proposed by Almendros-Marques, et al.
|
throughout study completion on average of one year
|
Oral health related quality of life: Brazilian version of OHIP-14 questionnaire
Time Frame: throughout study completion on average of one year
|
Oral health related quality of life (OHRQoL) were assessed by Brazilian version of OHIP-14 questionnaire.
This instrument consists of 14 items arranged in 7 factors: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.
The answers were given corresponding to a total of 5 points on a Likert-type scale.
The scale included the following responses: never (coded 0), hardly ever (coded 1), occasionally (coded 2), fairly often (coded 3), and very often (coded 4).
The OHIP-14 scale ranged from 0 to 56, with higher scores indicating poorer QoL
|
throughout study completion on average of one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Waldyr A. Jorge, University of Sao Paulo
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 (Actual)
May 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
July 13, 2019
First Submitted That Met QC Criteria
July 16, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
July 18, 2019
Last Update Submitted That Met QC Criteria
July 16, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Third molar Re
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Study Data/Documents
-
Study Protocol
Information identifier: 10.1016/j.joms.2011.09.034
-
Clinical Study Report
Information identifier: 10.1016/j.joms.2011.09.034
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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