Assessment of Gingival Thickness Using Colored Periodontal Probe

NCT ID: NCT05706480

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-03-01

Brief 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.

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.

Conditions

Gingival Phenotype

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

colored periodontal probes (CPP)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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).

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Misr International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zainab Hafez, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer, faculty of oral and dental medicine misr international university

Shahinaz Al ashiry, Asso. Prof

Role: STUDY_DIRECTOR

Associate professor, faculty of oral and dental medicine misr international university

Yahia Hassan, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer, faculty of oral and dental medicine misr international universit

Locations

Faculty of oral and dental medicine, Misr international university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

PER 4261006

Identifier Type: -

Identifier Source: org_study_id