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

February 16, 2018 updated by: Ozge Gokturk, Tokat Gaziosmanpasa University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60250
        • Gaziosmanpasa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokat Gaziosmanpasa University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ozge Gokturk, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-KAEK-131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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