Assessment of Gingival Thickness Using Colored Periodontal Probe

Gingival Phenotype Clinical Trial

Official title:

Assessment of Gingival Thickness Using Colored Periodontal Probe Assessment Method: A Cross-Sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706480
• Other study ID #: PER 4261006
• Status: Recruiting
• Start date: February 2025
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: Misr International University
• Contact: Zainab Hafez, Lecturer
• Phone: +01221334637
• Email: zeinab.hafez[@]miuegypt.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Phenotype

Intervention

Diagnostic Test:
• colored periodontal probes (CPP)
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
• standard periodontal probes (SPP)
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
• transgingival sounding with an endodontic file
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).

Locations

Country	Name	City	State
Egypt	Faculty of oral and dental medicine, Misr international university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Misr International University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gingival thickness	determination of the thickness of the gingival tissues	baseline
Secondary	Keratinized tissue width	measuring the width of the keratinized tissue width in mm	baseline
Secondary	Probing depth	measuring of the distance from the gingival margin to the base of the pocket in mm	baseline