Assessment of Gingival Thickness Using Colored Periodontal Probe

NCT05706480 | Completed DMC

• 1 other identifier: PER 4261006
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Phenotype

Keywords

Gingival thickness; Colored periodontal probe (CPP); Standard periodontal probe (SPP); Trans gingival sounding

Outcome Measures

Primary Outcomes (1)

• gingival thickness

  determination of the thickness of the gingival tissues

  baseline

Secondary Outcomes (2)

• Keratinized tissue width

  baseline

• Probing depth

  baseline

Study Arms (1)

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

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

Interventions

colored periodontal probes (CPP) 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

Periodontally clinically healthy patients

standard periodontal probes (SPP) 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

Periodontally clinically healthy patients

transgingival sounding with an endodontic file 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).

Periodontally clinically healthy patients

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Periodontally clinically healthy patients, aged from 18 to 65 years old, with the presence of anterior teeth in mandible and maxilla and good oral hygiene

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Faculty of oral and dental medicine, Misr international university

Cairo, 12345, Egypt

Location

Study Officials

• Zainab Hafez, Lecturer

  Lecturer, faculty of oral and dental medicine misr international university

  PRINCIPAL INVESTIGATOR

• Shahinaz Al ashiry, Asso. Prof

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

  STUDY DIRECTOR

• Yahia Hassan, Lecturer

  Lecturer, faculty of oral and dental medicine misr international universit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 31, 2023
• Study Start: December 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2024-11

Locations

EG (1)