Gingival EnlargementNCT03436537
Development and Validation of the Periodontal Aesthetic Perception Scale in Patients With Periodontal Problems
An observational study of Gingival Enlargement and Gingival Recession, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Enlargement, Gingival Recession
- What is being tested?
- Periodontal Aesthetic Perception Scale
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- The presence of gingival recession (Miller Class I, II, III, or IV) in maxillary and mandibular anterior teeth.
- -The presence of gingival enlargement (Grade 0, I, II, III, or IV) in maxillary and mandibular anterior teeth.
Who cannot join
- The presence of prosthesis, tooth loss or caries in the anterior teeth
- The precence of the psychological or systemic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60250
About this study
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.
Read the 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.
- Conditions
- Gingival Enlargement, Gingival Recession
- Being tested
- Periodontal Aesthetic Perception Scale
- Keywords
- aesthetic, development, periodontal, reliability, validity
- Medical subject headings
- Gingival Hyperplasia, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Aesthetic Perception ScaleOther
Patients answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale
| Study group | Role | What they receive |
|---|---|---|
| Gingival recession (GR) group | GR group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale Receives: Other: Periodontal Aesthetic Perception Scale | |
| Gingival enlargement (GE) group | GE group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale. Receives: Other: Periodontal Aesthetic Perception Scale | |
| periodontal healthy (H) group | H group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale. Receives: Other: Periodontal Aesthetic Perception Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start2 Jan 2017
- Primary completion1 Jul 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival EnlargementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Gokturk, Tokat Gaziosmanpasa University
- Investigators
- Ozge Gokturk, Study director, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436537
- Sponsor's protocol ID
- 17-KAEK-131
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
PubMed 8193981
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Periodontal Aesthetic Perception Scale in Patients With Periodontal Problems
- ClinicalTrials.gov ID
- NCT03436537
- Acronym / sponsor ID
- 17-KAEK-131
- Conditions
- Gingival Enlargement, Gingival Recession
- Keywords
- aesthetic, development, periodontal, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gingival recession (GR) group | – | Other: Periodontal Aesthetic Perception ScaleGR group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale |
| Gingival enlargement (GE) group | – | Other: Periodontal Aesthetic Perception ScaleGE group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale. |
| periodontal healthy (H) group | – | Other: Periodontal Aesthetic Perception ScaleH group answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- The presence of gingival recession (Miller Class I, II, III, or IV) in maxillary and mandibular anterior teeth.
- -The presence of gingival enlargement (Grade 0, I, II, III, or IV) in maxillary and mandibular anterior teeth.
Key exclusion criteria (2 listed)
- The presence of prosthesis, tooth loss or caries in the anterior teeth
- The precence of the psychological or systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal Aesthetic Perception ScalePatients answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale | Other | Gingival enlargement (GE) group, Gingival recession (GR) group, periodontal healthy (H) group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Results publication: PubMed 8193981Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
Related trials for Gingival Enlargement
Enrolling by invitationEarly Phase 1
Testing the Efficacy of Photobiomodulation Therapy and Hyaluronic Acid Gel on Post-surgical Healing After Gingivectomy
Gingival Hyperplasia, Gingival Hypertrophy
Recruiting
The Effect of Ozone Therapy on Gingivoplasty
Gingival Enlargement
Recruiting
Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements
Localized Gingival Enlargement, Epulides
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozge Gokturk study director
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Enlargement and Gingival Recession, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of PAPS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03436537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.