- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706480
Assessment of Gingival Thickness Using Colored Periodontal Probe
Assessment of Gingival Thickness Using Colored Periodontal Probe Assessment Method: A Cross-Sectional Study
the accuracy of different assessment methods of the gingival tissue thickness can be controversial affecting their correct classification and the techniques of gingival tissue management in case of mucogingival problems.
Aim: The aim of this study is to evaluate the accuracy of different assessment methods of measuring GT and to classify into the different gingival phenotypes.
Study Overview
Status
Conditions
Detailed Description
The accuracy of different assessment methods of the gingival tissue thickness can be controversial affecting their correct classification and the techniques of gingival tissue management in case of mucogingival problems.
The aim of this study is to evaluate the accuracy of different assessment methods of measuring GT and to classify into the different gingival phenotypes.
Periodontally clinically healthy patients will be recruited from the Dental Clinic Complex (MIU) according to eligibility criteria. The gingival tissue thickness will be measured using probe-colored periodontal probes (CPP), standard periodontal probes (SPP) and transgingival sounding with an endodontic file (ISO #20), visual judgment using photographs will be done to the three assessment methods. All readings including GT (1ry outcome) as well as keratinized tissue width and probing depth will be carried out by three calibrated outcome assessors. Data collected will be tabulated and statistically analyzed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt, 12345
- Faculty of oral and dental medicine, Misr international university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Systemically free patients (American Society of Anesthesiologists (ASA) I or II)
- Patients having a state of clinical periodontal health
- Patients aged from 18 to 65 years old
- Both genders
- Presence of anterior teeth in mandible and maxilla.
- Good oral hygiene
Exclusion Criteria:
- Carious teeth, teeth with crowns or veneers and non-carious cervical lesions
- Patients with healthy reduced periodontium.
- Smokers
- Pregnant and lactating females
- Patients taking drugs that affect the gingival tissues
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Periodontally clinically healthy patients
In Periodontally clinically healthy patients fulfilling the eligibility criteria.
The gingival tissue thickness will be measured using probe-colored periodontal probes (CPP), standard periodontal probes (SPP) and transgingival sounding with an endodontic file (ISO #20), visual judgment using photographs will be done to the three assessment methods
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The CPP will be placed with a force of approximately 0.2 N into the sulcus at the mid buccal surface of the tooth and the color that will be apparent from the tissue will be recorded
The SPP (William's graduated probe) will be placed with a force of approximately 0.2 N into the sulcus at the mid buccal surface of the tooth and the color that will be apparent from the tissue will be recorded
the gingival thickness using the transgingival sounding.
After application of local anesthesia gel an endodontic file (ISO 20) with a rubber stopper will be inserted perpendicularly into the buccal aspect of the gingiva (1 mm below the gingival margin) until it touches the tooth surface.
The insertion depth will be ensured through placing the rubber stopper in contact with the gingiva and fixing its position and the distance between the tip and the rubber stopper will be calibrated using a manual calibration device (endodontic ruler).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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gingival thickness
Time Frame: baseline
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determination of the thickness of the gingival tissues
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Keratinized tissue width
Time Frame: baseline
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measuring the width of the keratinized tissue width in mm
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baseline
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Probing depth
Time Frame: baseline
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measuring of the distance from the gingival margin to the base of the pocket in mm
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yahia Hassan, Lecturer, Lecturer, faculty of oral and dental medicine misr international universit
- Principal Investigator: Zainab Hafez, Lecturer, Lecturer, faculty of oral and dental medicine misr international university
- Study Director: Shahinaz Al ashiry, Asso. Prof, Associate professor, faculty of oral and dental medicine misr international university
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
Other Study ID Numbers
- PER 4261006
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
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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