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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04024644
Other study ID # Third molar Re
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2013
Est. completion date May 1, 2014

Study information

Verified date July 2019
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date May 1, 2014
Est. primary completion date October 1, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary 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 periodontal disease 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
Secondary Position of the lower third molars 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
Secondary Oral health related quality of life: Brazilian version of OHIP-14 questionnaire 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
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