Assessment of Gingival Thickness Using Colored Periodontal Probe

Sponsor
Misr International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05706480
Collaborator
(none)
50
1
3.9
12.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: colored periodontal probes (CPP)
  • Diagnostic Test: standard periodontal probes (SPP)
  • Diagnostic Test: transgingival sounding with an endodontic file

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Gingival Thickness Using Colored Periodontal Probe Assessment Method: A Cross-Sectional Study
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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)
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

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

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).

Outcome Measures

Primary Outcome Measures

  1. gingival thickness [baseline]

    determination of the thickness of the gingival tissues

Secondary Outcome Measures

  1. Keratinized tissue width [baseline]

    measuring the width of the keratinized tissue width in mm

  2. Probing depth [baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of oral and dental medicine, Misr international university Cairo Egypt 12345

Sponsors and Collaborators

  • Misr International University

Investigators

  • 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
  • Principal Investigator: Yahia Hassan, Lecturer, Lecturer, faculty of oral and dental medicine misr international universit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Misr International University
ClinicalTrials.gov Identifier:
NCT05706480
Other Study ID Numbers:
  • PER 4261006
First Posted:
Jan 31, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Misr International University

Study Results

No Results Posted as of Jan 31, 2023