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Development and Validation of the Periodontal Aesthetic Perception Scale in Patients With Periodontal Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03436537
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ozge Gokturk, Tokat Gaziosmanpasa University

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Gingival Enlargement Gingival Recession Other: Periodontal Aesthetic Perception Scale

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Development and Validation of the Periodontal Aesthetic Perception Scale in Patients With Periodontal Problems
Actual Study Start Date : January 2, 2017
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : December 1, 2017
Groups and Cohorts
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Group/Cohort Intervention/treatment
Gingival recession (GR) group
GR group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale
 Other: 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.
 Other: 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.
 Other: Periodontal Aesthetic Perception Scale
Patients answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale


Outcome Measures
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Primary Outcome Measures :
  1. Validity of PAPS [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who fulfilled the criteria for inclusion presenting at the periodontology clinic were asked to participate in the study and those agreeing to interview were asked how and what aesthetically disturbing symptoms in their gingiva.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436537


Locations
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Turkey
Gaziosmanpasa University
Tokat, Turkey, 60250
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
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Study Director: Ozge Gokturk Study Principal Investigator
More Information
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Publications of Results:

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Responsible Party: Ozge Gokturk, asst. assoc., Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT03436537    
Other Study ID Numbers: 17-KAEK-131
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ozge Gokturk, Tokat Gaziosmanpasa University:
aesthetic
development
periodontal
reliability
validity
Additional relevant MeSH terms:
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Gingival Recession
Gingival Hyperplasia
Gingival Hypertrophy
Gingival Overgrowth
Gingival Diseases
 Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy