Ultrasonic vs Radiographic Measurement of Gingival Biotype. A Novel Method

NCT03735394 | Completed DMC

• 1 other identifier: ORT-ECL-2013-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

Gingival thickness; gingival biotype; gingival recession; maxilla; mandible

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (2)

• Differences in tissue thickness according to gender

  1 day

• thickness biotype differences

  1 day

Study Arms (1)

Gingival Biotype

EXPERIMENTAL

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

Interventions

ultrasonic probe DIAGNOSTIC_TEST

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.

Also known as: tangential x-ray

Gingival Biotype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Related Publications (2)

• 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.

  PMID: 19811580 BACKGROUND

• 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.

  PMID: 24836578 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Andreu Puigdollers

  Chairman

  STUDY DIRECTOR

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: assitant professor. Doctor in medical science

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: November 8, 2018
• Study Start: April 15, 2017
• Primary Completion: May 22, 2017
• Study Completion: September 8, 2017
• Last Updated: November 8, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be available during 1 year of study completion
• 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

Locations

ES (1)