CClinicalTrials.gg
CompletedNCT04024644Updated Jul 18, 2019

Third Molar: Caries, Periodontal Disease and Quality of Life

An observational study in Caries and Periodontal Diseases, sponsored by University of Sao Paulo. Completed. Per ClinicalTrials.gov, last updated 2019-07-18.

Sponsored by University of Sao Paulo · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
116
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Caries
  • Periodontal Diseases

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Keywords

  • third molar
  • dental caries
  • periodontal disease
  • quality of life
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In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 116 is above the median of 100 across 291 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Other
Time perspective
Other
Enrollment
116 participants (actual)
Patient registry
No
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What researchers measure

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.

    Time frame: throughout study completion on average of one year

Secondary outcomes

  1. 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.

    Time frame: throughout study completion on average of one year

  2. 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.

    Time frame: throughout study completion on average of one year

  3. 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

    Time frame: throughout study completion on average of one year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04024644
Lead sponsor
University of Sao Paulo
Responsible party
Waldyr Antônio Jorge (PhD, clinical professor, University of Sao Paulo) — Principal investigator
First posted
Jul 18, 2019
Start date
May 1, 2013
Primary completion
Oct 1, 2013
Completion
May 1, 2014
Last update
Jul 18, 2019

Study contacts

Waldyr A. Jorge
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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