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Ultrasonic vs Radiographic Measurement of Gingival Biotype. A Novel Method

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ultrasonic probe
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gingival Recession focused on measuring Gingival thickness, gingival biotype, gingival recession, maxilla, mandible

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitat Internacional de Catalunya

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gingival Biotype

Arm Description

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

Outcomes

Primary Outcome Measures

compare between maxilla and mandibular biotype measured with the periodontal probe
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

Secondary Outcome Measures

Differences in tissue thickness according to gender
Classify patients in male or female and measure tissue thickness regardless of the biotype measured with both the radiographic technique and ultrasonic device
thickness biotype differences
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

Full Information

First Posted
October 13, 2018
Last Updated
November 6, 2018
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT03735394
Brief Title
Ultrasonic vs Radiographic Measurement of Gingival Biotype. A Novel Method
Official Title
Labial Gingival and Osseous Thickness of Upper and Lower Incisors in Thick and Thin Biotypes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
May 22, 2017 (Actual)
Study Completion Date
September 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: Gingival thickness on the upper incisor Bone thickness on the upper incisor Gingival thickness on the lower incisor 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Gingival thickness, gingival biotype, gingival recession, maxilla, mandible

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gingival Biotype
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasonic probe
Other Intervention Name(s)
tangential x-ray
Intervention Description
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.
Primary Outcome Measure Information:
Title
compare between maxilla and mandibular biotype measured with the periodontal probe
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Differences in tissue thickness according to gender
Description
Classify patients in male or female and measure tissue thickness regardless of the biotype measured with both the radiographic technique and ultrasonic device
Time Frame
1 day
Title
thickness biotype differences
Description
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
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreu Puigdollers
Organizational Affiliation
Chairman
Official's Role
Study Director
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
19811580
Citation
Eghbali A, De Rouck T, De Bruyn H, Cosyn J. The gingival biotype assessed by experienced and inexperienced clinicians. J Clin Periodontol. 2009 Nov;36(11):958-63. doi: 10.1111/j.1600-051X.2009.01479.x. Epub 2009 Oct 6.
Results Reference
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PubMed Identifier
24836578
Citation
Zweers J, Thomas RZ, Slot DE, Weisgold AS, Van der Weijden FG. Characteristics of periodontal biotype, its dimensions, associations and prevalence: a systematic review. J Clin Periodontol. 2014 Oct;41(10):958-71. doi: 10.1111/jcpe.12275. Epub 2014 Aug 27.
Results Reference
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Ultrasonic vs Radiographic Measurement of Gingival Biotype. A Novel Method

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