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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03436537
Other study ID # 17-KAEK-131
Secondary ID
Status Completed
Phase N/A
First received February 12, 2018
Last updated February 16, 2018
Start date January 2, 2017
Est. completion date December 1, 2017

Study information

Verified date February 2018
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 1, 2017
Est. primary completion date July 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Other:
Periodontal Aesthetic Perception Scale
Patients answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale

Locations

Country Name City State
Turkey Gaziosmanpasa University Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Validity of PAPS 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
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