- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06502782
Areal and Linear Comparison of Gingival Recession (agr)
Areal and Linear Comparison of the Effect of Gingival Phenotype on Gingival Recession
Recent advances in digital technology have led to the emergence of precise methods for measuring gingival recession and tissue thickness. This study aimed to compare digital measurement methods and conventional periodontal probe measurements for the assessment of gingival recession influenced by the gingival phenotype.
This study involved 128 gingival recession sites from 28 systemically healthy patients aged 18-45 years. The participants were categorized into two groups on the basis of gingival thickness. The plaque index, gingival index, probing depth, clinical attachment level, gingival recession depth, and gingival recession width, and keratinized gingival thickness and width were measured using a manual periodontal probe and an intraoral optical surface scanner. Statistical analysis was performed with nonparametric tests because the data were not normally distributed. P<0.05 indicated statistical significanct.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bolu, Turkey, 14030
- Bolu abant Izzet Baysal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: The study included systemically healthy subjects aged 18-45 years with systemic disease or systemic disease under control.
Exclusion Criteria: The exclusion criteria were as follows:
- Patients with a history of radiotherapy,
- Patients with chemotherapy,
- Immunosuppressive use,
- Tobacco use,
- Smoking,
- Patients with labially exposed teeth and teeth with prominent root protrusions,
- Pregnancy and lactation,
- Patients with uncontrolled diabetes,
- Patients with postorthodontic extractions,
- Patients with gingival recession, .Patients with gingival enlargement caused by piercing and nail-biting habits.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Thin phenotype
A thickness of 1 mm or less is classified as thin gingival tissue.
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Gingival recession sites were scanned with an intraoral optical surface scanner, and STL images were recorded.
The images were imported into image analysis software.
The depth, width and area of gingival recession were calculated using Autocat program.
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Thick phenotype
A thickness of more than 1 mm is classified as thick gingival tissue.
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Gingival recession sites were scanned with an intraoral optical surface scanner, and STL images were recorded.
The images were imported into image analysis software.
The depth, width and area of gingival recession were calculated using Autocat program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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keratinized gingival thickness
Time Frame: Baseline
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Keratinized gingival thickness refers to the vertical measurement of the gingival tissue that extends from the free gingival margin to the mucogingival junction, characterized by a keratinized epithelial layer which provides enhanced protection and stability to the underlying periodontal structures.
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Baseline
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keratinized gingival width
Time Frame: Baseline
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Keratinized gingival width refers to the horizontal dimension of the gingival tissue that is keratinized, measured from the free gingival margin to the mucogingival junction.
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Baseline
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Gingival recession depth
Time Frame: Baseline
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Gingival recession is the apical migration of the gingival margin away from the cemento-enamel junction (CEJ), resulting in the exposure of the root surface of a tooth.
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Baseline
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Gingival recession width
Time Frame: Baseline
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Gingival recession width refers to the horizontal measurement from the exposed cemento-enamel junction (CEJ) to the apical point of the gingival margin, indicating the extent of root surface exposure.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Bleeding on probing
Time Frame: Baseline
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Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements.
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Baseline
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Plaque index
Time Frame: Baseline
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The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth
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Baseline
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Clinical attachment level
Time Frame: Baseline
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CAL is calculated by subtracting the gingival margin level from the probing depth.
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Baseline
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Gingival index
Time Frame: Baseline
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This measurement is based on the presence or absence of bleeding on gentle probing
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Baseline
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Periodontal pocket depth
Time Frame: Baseline
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A pathologically deepened gingival sulcus around a tooth at the gingival margin.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/288
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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