Ultrasonic vs Radiographic Measurement of Gingival Biotype. A Novel Method

November 6, 2018 updated by: Juan Rossell, Universitat Internacional de Catalunya

Labial Gingival and Osseous Thickness of Upper and Lower Incisors in Thick and Thin Biotypes

This clinical study consists on taking 2 different records of the upper and lower incisors area : 1) a perpendicular x-ray and 2) an ultrasonic measurement of gingival thickness on the labial plate. Both measurements are used in order to measure gingival and bone thickness.

The aim was to verify the reliability of the tissue measurements of an ultrasonic technique compared with the radiographic technique and to verify whether the biotype has correlation between the maxillary and mandibular biotype in the same patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The examination of the patients included:

  • One color photograph of the upper and lower incisors complex with the periodontal probe introduced on the gingival sulcus
  • Gingival thickness of the most protruded upper and lower incisors was measured with the biometric scanner PIROP. A lip expander was placed and clorhexidine gel was applied on top of the ultrasonic head for better wave conduction. Measurements were taken 10 times at the same point and a mean measurement was obtained.
  • A tangential radiograph was taken on each patient perpendicular to the axis of the crown of the central upper and lower incisors with a periapical film holding system, and a metal strip (5mm x 1mm x 0,1mm) placed labial to the keratinized gingiva following the inclination of the incisor. A lip expander was used to keep the lips from touching the metal strip. Air was blown over the attached gingiva before placing the metal strip. The metal strip was placed along the long axis of the most protruded lower incisor crown.

All patients were evaluated and categorized in one of three possible categories: A1 (7 patients, 23,3%), A2 (12 patients, 40%), and B (11 patients, 36,7%). The patients were assigned into each category by two examiners, according to the visual and clinical aspect of the keratinized gingiva in the lower incisors. Group A1 and A2 both had thin keratinized gingiva and differed in width (group A1 comprised values ≤2mm, and group A2 had width values >2mm of keratinized gingiva). Group B comprised thick and wide keratinized gingiva. Width of gingiva was measured with a periodontal probe. Thickness of gingiva was assessed by probe transparency, where the examiner determined whether the periodontal probe was visible through the marginal soft tissue.

Radiographic measurements

Radiographs were scanned at a 1:1 scale. Scanned images were saved in JPEG format. Millimetric measurements were made using the Adobe Photoshop program to a 0.1mm precision. Four measurements were taken on each radiograph:

  1. Gingival thickness on the upper incisor
  2. Bone thickness on the upper incisor
  3. Gingival thickness on the lower incisor
  4. Bone thickness on the lower incisor

Gingival thickness was measured on the radiographs to compare it with the measurements taken with the biometric scanner. This was a founded and a reliable method to validate the use of the scanner. A master file was created and the data were statistically analyzed using a statistical software package.

Size of the sample was obtained with the correlation of lower gingiva and thickness of lower gingiva. The result was 26 calculated with the correlation coefficient 0,587. A 20% tax of follow-up loss was estimated.

Intraexaminer reliability was determined using intraclass correlation coefficient (ICC) with a positive confidence interval at 95% (IC 95%). An ICC was used to compare the valid method for group classification between visual and probe transparency methods.

The data were subjected to 95% confidence interval for the mean of all variables. The strength of correlation was determined by a P value <0.05, which was considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat Del Vallès, Barcelona, Spain, 08195
        • Universitat Internacional de Catalunya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 18 years or older,
  • presence of all lower incisors
  • good periodontal health without bone loss or gingival inflammation
  • no dental compensations of skeletal malocclusion
  • crowding of less than 4mm
  • no history of dental or traumatic lesions in lower incisors

Exclusion Criteria:

  • gingival inflammation
  • daily smokers
  • patients taking drugs that causes gingival inflammation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gingival Biotype
A Periodontal probe was used to differentiate between thick and thin biotypes and patients were classified into 3 possible categories of Gingival Biotype (A1, A2 and B) according to Müller & Eger (https://doi.org/10.1034/j.1600-051x.2000.027009621.x). On each group two measurements were taken on the most protruded lower and upper central incisor: 1/ a tangential radiographic film and 2/ an ultrasonic probe measurement with the PIROP Biometric scanner (G-scan) form Echoson
Diagnostic test: ultrasonic probe
apply the head of the ultrasonic probe on the keratinized tissue of the most protruded upper and lower central incisor in order to measure tissue thickness.
Other Names:
  • tangential x-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare between maxilla and mandibular biotype measured with the periodontal probe
Time Frame: 1 day
Classify all patients into one of the three established categories (A1, A2, B) with the aid of a periodontal probe, and compare within the same patient if the biotype of maxilla and mandible is the same or it differs
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in tissue thickness according to gender
Time Frame: 1 day
Classify patients in male or female and measure tissue thickness regardless of the biotype measured with both the radiographic technique and ultrasonic device
1 day
thickness biotype differences
Time Frame: 1 day
establish a possible correlation between maxilla and mandible tissue thickness according to the three possible established categories of biotype measured with radiographic technique and ultrasonic device
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Investigators

  • Study Director: Andreu Puigdollers, Chairman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2017

Primary Completion (Actual)

May 22, 2017

Study Completion (Actual)

September 8, 2017

Study Registration Dates

First Submitted

October 13, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORT-ECL-2013-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All identified data of individuals measurements will be available

IPD Sharing Time Frame

data will be available during 1 year of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by an external reviewer, if any requestor wants access there will be a need to sign a data access agreement

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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