NCT05478148

Brief Summary

This study evaluates the 4 different techniques used in clinical measurement of gingival phenotype. 1) Tranclusency of UNC-15 Periodontal Probe, 2) Transgingival probing with Endodontic file (#20), 3)Transgingival Probing with Modified Florida Probe and 4) Translucency Colorvue Biotype Probe. The aim of our study is to evaluate the reliability and applicability of the current examination methods recommended in order to improve the deficiencies of the traditional examination methods used in the evaluation of the gingival phenotype.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

July 25, 2022

Last Update Submit

July 28, 2022

Conditions

Keywords

gingival phenotypegingival thickness

Outcome Measures

Primary Outcomes (1)

  • Feasibility and reliability of techniques

    Comparison between the conventional techniques(Periodontal probe and Endodontic file) and modern techniques(Colorvue Biotype Probe and Modified Florida Probe) in terms of reliability and feasibility.

    1 day

Secondary Outcomes (1)

  • The amount of gingival thickness and the width of the keratinized tissue

    1 day

Study Arms (1)

Gingival phenotype

EXPERIMENTAL

A Periodontal probe was used to differentiate between thick and thin phenotypes and Color coded Biotype Probe was used to classified the phenotype as thin, moderate, thick and very thick phenotypes. Endodontic File and Florida probe were used to measure the gingival thickness.

Device: Gingival thickness

Interventions

After the classification the phenotype, gingival thickness was measured with Endodontic File and Modified Florida Probe from the 3 different points. First point was the probing depth level, second one was 1mm apical to this level and third one from the 2mm apical to probing depth.

Gingival phenotype

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy individuals,
  • Periodontal healthy individuals with a whole mouth plaque score of 15% and a whole mouth bleeding score of less than 15%,
  • Individuals who have not undergone periodontal treatment (subgingival curettage, gingivectomy, crown lengthening, etc.) in the last 6 months,
  • Absence of dental compensations of skeletal malocclusion.

You may not qualify if:

  • Individuals who smoke and have a history of smoking,
  • Individuals who have undergone orthodontic treatment,
  • Individuals using drugs that may cause gingival hyperplasia (immunosuppressive drugs, calcium channel blockers, anticonvulsant drugs, etc.)
  • Individuals who are in pregnancy or lactation period,
  • Presence of structural defects, crowns or large restorations in the maxillary anterior teeth to be measured,
  • The presence of missing or supernumerary teeth in the maxillary anterior teeth to be measured,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University Faculty of Dentistry

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asistant

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 28, 2022

Study Start

April 25, 2021

Primary Completion

March 30, 2022

Study Completion

May 25, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations