- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04024644
Third Molar: Caries, Periodontal Disease and Quality of Life
16 juli 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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).
Studietyp
Observationell
Inskrivning (Faktisk)
116
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Caries
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
periodontal disease
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Waldyr A. Jorge, University of Sao Paulo
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2013
Primärt slutförande (Faktisk)
1 oktober 2013
Avslutad studie (Faktisk)
1 maj 2014
Studieregistreringsdatum
Först inskickad
13 juli 2019
Först inskickad som uppfyllde QC-kriterierna
16 juli 2019
Första postat (Faktisk)
18 juli 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 juli 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Third molar Re
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Studiedata/dokument
-
Studieprotokoll
Informationsidentifierare: 10.1016/j.joms.2011.09.034
-
Klinisk studierapport
Informationsidentifierare: 10.1016/j.joms.2011.09.034
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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