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Completed

NCT Number: NCT05706480

Assessment of Gingival Thickness Using Colored Periodontal Probe

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.

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Key information

Conditions

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of oral and dental medicine, Misr international university

Cairo, 12345, Egypt

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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).

Primary outcomes

  1. gingival thickness

    Time frame: baseline

    determination of the thickness of the gingival tissues

Secondary outcomes

  1. Keratinized tissue width

    Time frame: baseline

    measuring the width of the keratinized tissue width in mm

  2. Probing depth

    Time frame: baseline

    measuring of the distance from the gingival margin to the base of the pocket in mm

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2023
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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