- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04024644
Third Molar: Caries, Periodontal Disease and Quality of Life
16. Juli 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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).
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
116
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Caries
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
periodontal disease
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Waldyr A. Jorge, University of Sao Paulo
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Mai 2013
Primärer Abschluss (Tatsächlich)
1. Oktober 2013
Studienabschluss (Tatsächlich)
1. Mai 2014
Studienanmeldedaten
Zuerst eingereicht
13. Juli 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. Juli 2019
Zuerst gepostet (Tatsächlich)
18. Juli 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Juli 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Juli 2019
Zuletzt verifiziert
1. Juli 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Third molar Re
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Studiendaten/Dokumente
-
Studienprotokoll
Informationskennung: 10.1016/j.joms.2011.09.034
-
Klinischer Studienbericht
Informationskennung: 10.1016/j.joms.2011.09.034
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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