Back to resultsTECHNIQUES USED IN EVALUATION OF GINGIVAL PHENOTYPE
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gingival thickness
Sponsored by
About this trial
This is an interventional diagnostic trial for Gingival Recession focused on measuring gingival phenotype, gingival thickness
Eligibility Criteria
Inclusion Criteria:
- Systemically healthy individuals,
- Periodontal healthy individuals with a whole mouth plaque score of 15% and a whole mouth bleeding score of less than 15%,
- Individuals who have not undergone periodontal treatment (subgingival curettage, gingivectomy, crown lengthening, etc.) in the last 6 months,
- Absence of dental compensations of skeletal malocclusion.
Exclusion Criteria:
- Individuals who smoke and have a history of smoking,
- Individuals who have undergone orthodontic treatment,
- Individuals using drugs that may cause gingival hyperplasia (immunosuppressive drugs, calcium channel blockers, anticonvulsant drugs, etc.)
- Individuals who are in pregnancy or lactation period,
- Presence of structural defects, crowns or large restorations in the maxillary anterior teeth to be measured,
- The presence of missing or supernumerary teeth in the maxillary anterior teeth to be measured,
Sites / Locations
- Ondokuz Mayis University Faculty of Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gingival phenotype
Arm Description
A Periodontal probe was used to differentiate between thick and thin phenotypes and Color coded Biotype Probe was used to classified the phenotype as thin, moderate, thick and very thick phenotypes. Endodontic File and Florida probe were used to measure the gingival thickness.
Outcomes
Primary Outcome Measures
Feasibility and reliability of techniques
Comparison between the conventional techniques(Periodontal probe and Endodontic file) and modern techniques(Colorvue Biotype Probe and Modified Florida Probe) in terms of reliability and feasibility.
Secondary Outcome Measures
The amount of gingival thickness and the width of the keratinized tissue
To determine the cut-off dimensions by evaluating the gingival thickness at 3 different points.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05478148
Brief Title
TECHNIQUES USED IN EVALUATION OF GINGIVAL PHENOTYPE
Official Title
COMPARISON OF THE CONVENTIONAL AND MODERN TECHNIQUES USED IN CLINICAL EVALUATION AND CLASSIFICATION OF THE GINGIVAL PHENOTYPE.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 25, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates the 4 different techniques used in clinical measurement of gingival phenotype. 1) Tranclusency of UNC-15 Periodontal Probe, 2) Transgingival probing with Endodontic file (#20), 3)Transgingival Probing with Modified Florida Probe and 4) Translucency Colorvue Biotype Probe.
The aim of our study is to evaluate the reliability and applicability of the current examination methods recommended in order to improve the deficiencies of the traditional examination methods used in the evaluation of the gingival phenotype.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival phenotype, gingival thickness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gingival phenotype
Arm Type
Experimental
Arm Description
A Periodontal probe was used to differentiate between thick and thin phenotypes and Color coded Biotype Probe was used to classified the phenotype as thin, moderate, thick and very thick phenotypes. Endodontic File and Florida probe were used to measure the gingival thickness.
Intervention Type
Device
Intervention Name(s)
Gingival thickness
Intervention Description
After the classification the phenotype, gingival thickness was measured with Endodontic File and Modified Florida Probe from the 3 different points. First point was the probing depth level, second one was 1mm apical to this level and third one from the 2mm apical to probing depth.
Primary Outcome Measure Information:
Title
Feasibility and reliability of techniques
Description
Comparison between the conventional techniques(Periodontal probe and Endodontic file) and modern techniques(Colorvue Biotype Probe and Modified Florida Probe) in terms of reliability and feasibility.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
The amount of gingival thickness and the width of the keratinized tissue
Description
To determine the cut-off dimensions by evaluating the gingival thickness at 3 different points.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systemically healthy individuals,
Periodontal healthy individuals with a whole mouth plaque score of 15% and a whole mouth bleeding score of less than 15%,
Individuals who have not undergone periodontal treatment (subgingival curettage, gingivectomy, crown lengthening, etc.) in the last 6 months,
Absence of dental compensations of skeletal malocclusion.
Exclusion Criteria:
Individuals who smoke and have a history of smoking,
Individuals who have undergone orthodontic treatment,
Individuals using drugs that may cause gingival hyperplasia (immunosuppressive drugs, calcium channel blockers, anticonvulsant drugs, etc.)
Individuals who are in pregnancy or lactation period,
Presence of structural defects, crowns or large restorations in the maxillary anterior teeth to be measured,
The presence of missing or supernumerary teeth in the maxillary anterior teeth to be measured,
Facility Information:
Facility Name
Ondokuz Mayis University Faculty of Dentistry
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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TECHNIQUES USED IN EVALUATION OF GINGIVAL PHENOTYPE
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