NCT04845581

Brief Summary

Compare two diagnostic methods: UGTM and CBCT/CAD/PDIP in determing the gingival phenotype in group of 30 periodontally healthy patients. Both methods were useful to establishing the gingival phenotype, however, ultrasonic method was more precisely for measurement of gingival thickness. There was positive correlation between the mean values of SGT and WKT and this indicates the need to measure these parameters in order to determine gingival phenotype.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
Last Updated

April 15, 2021

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

March 22, 2021

Last Update Submit

April 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determination the gingival phenotype

    The UGTM and CBCT/CAD/PDIP methods are useful to determining of gingival phenotype but more accurate and repeatability is UGTM. The presence of a positive correlation between SGT and WKT indicates the need to measured these parameters for the evaluation of GP. T. It is very important to determine the gingival phenotype for each dento-gingival unit especially before complicated dental treatment.

    october 2018 to august 2019

Interventions

Gingival thickness was measured using UGTM method and CBCT/ CAD with PDIP technology at upper incisors and canines in three points localized midbucally : Free gingival thickness (FGT), supracrestal ( SGT) and crestal (CGT). Width of keratinized tissue was measured using periodontal probe calibrated for 1 mm. The gingival phenotype was determined by both methods according to the following criteria: GT ≤ 0,7 mm - thin gingival phenotype, GT \> 0,7 mm ≤ 1,0 mm - medium gingival phenotype, GT \> 1,0 mm - thick gingival phenotype. Toincrease the repeatability of the results, two researchers tested the same values twice on 2days interval between sessions.

Eligibility Criteria

Age24 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

male 16 female 14

You may qualify if:

  • lack of general diseases
  • good oral hygiene
  • healthy periodontium - API ratio\<15%, BOP\<10%
  • no loss of clinical attachment in the examined areas (CAL=0)
  • no use of drugs
  • no addictions, especially cigarette smoking
  • no use of mobile prosthetic restorations and orthodontic appliances
  • no contraindications for X-ray examinations

You may not qualify if:

  • general diseases
  • poor oral hygiene
  • non healthy periodontium - API ratio\>15%, BOP\>10%
  • loss of clinical attachment in the examined areas (CAL\>1)
  • use of drugs that could influence the structure of the periodontal tissues
  • addictions, especially nicotinism
  • use of mobile prosthetic restorations and orthodontic appliances
  • contraindications for X-ray examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical University

Wroclaw, 52129, Poland

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • wojciech bednarz, prof

    wroclaw medical univeristy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

April 15, 2021

Study Start

October 11, 2018

Primary Completion

July 20, 2019

Study Completion

August 2, 2019

Last Updated

April 15, 2021

Record last verified: 2020-01

Locations