- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Tokat, Tyrkia, 60250
- Gaziosmanpasa University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Gingival recession (GR) group
GR group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale
|
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.
|
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.
|
Patients answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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.
|
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Ozge Gokturk, Study Principal Investigator
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 17-KAEK-131
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Gingival resesjon
-
Cairo UniversityUkjentGingival tykkelse | Gingival biotype | Periodontal sonde
-
University of BaghdadRekrutteringTykking; GingivalIrak
-
Tokat Gaziosmanpasa UniversityFullførtGingivalforstørrelseTyrkia
-
Alexandria UniversityFullførtGingivalforstørrelseEgypt
-
Tokat Gaziosmanpasa UniversityFullført
-
The University of Hong KongUkjent
-
University of Padova, School of Dental MedicineFullførtGingival resesjon | Gingival blødning | Gingival sykdomItalia
-
Inonu UniversityFullførtSårhelbredelse | Gingivalforstørrelse | Gingival overvekst | Blodplaterik fibrinTyrkia
-
British University In EgyptHar ikke rekruttert ennå