- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03436537
Development and Validation of the Periodontal Aesthetic Perception Scale in Patients With Periodontal Problems
Aesthetics for individuals become increasingly important, while the aesthetic effects of periodontal disease is an important issue that should be assessed by the patient's perception.
The results demonstrate that the periodontal aesthetic perception scale showed reliable and valid scores in healthy controls and periodontal patients.
The periodontal aesthetic perception scale may be an appropriate tool to assess periodontal esthetic in clinical and research settings.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Aim: The aim of this study is to develop and validate a periodontal aesthetic specific tool to assess aesthetic conditions perceived by patients with periodontal problems.
Methods: With patient interviews were identified a total of 22 statements that describe the non-aesthetic gingival appearance. These 22 items were reviewed by the dentists and then Periodontologists and the number of items in the survey was reduced to 7. Subsequently, three groups of patients were included in the study: Gingival recession (GR) group, gingival enlargement (GE) group and periodontal healthy (H) group. Consequently, the validity and reliability of the periodontal aesthetic perception scale (PAPS) were examined.
Results: According to the results of the Exploratory Factor Analysis (EFA), 1 item was removed from the scale. The final 6-item questionnaire was shown to have a two-domain structure. Cronbach's alpha for the whole scale was .766. The interclass correlation coefficients (ICCs) values were between 0.98 and 1.00, demonstrating excellent agreement. Overall, these findings indicated that the PAPS has good reliability.
Conclusion: This reliable, valid and short questionnaire specific to aesthetic conditions perceived by patients with periodontal problems may serve as a valued instrument in future clinical trials.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Tokat, Kalkun, 60250
- Gaziosmanpasa University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion criteria for gingival recession group:
- The presence of gingival recession (Miller Class I, II, III, or IV) in maxillary and mandibular anterior teeth.
Inclusion criteria for gingival enlargement group:
-The presence of gingival enlargement (Grade 0, I, II, III, or IV) in maxillary and mandibular anterior teeth.
Exclusion Criteria for all groups:
- The presence of prosthesis, tooth loss or caries in the anterior teeth
- The precence of the psychological or systemic disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Gingival recession (GR) group
GR group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale
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Patients answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale
|
|
Gingival enlargement (GE) group
GE group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale.
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Patients answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale
|
|
periodontal healthy (H) group
H group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale.
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Patients answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Validity of PAPS
Tidsramme: 6 months
|
The KMO (Kaiser-Meyer-Olkin) test produced a value of 0.80, which was greater than the recommended threshold value of 0.50.
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6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Ozge Gokturk, Study Principal Investigator
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17-KAEK-131
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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