Gingival RecessionNCT03735394
Ultrasonic vs Radiographic Measurement of Gingival Biotype. A Novel Method
A study testing ultrasonic probe in people with Gingival Recession, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- ultrasonic probe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2017to 8 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- gingival inflammation
- daily smokers
- patients taking drugs that causes gingival inflammation
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingival Recession
- Being tested
- ultrasonic probe
- Keywords
- Gingival thickness, gingival biotype, gingival recession, maxilla, mandible
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic probeDiagnostic test
Also called tangential x-ray
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: ultrasonic probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
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
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start15 Apr 2017
- Primary completion22 May 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Rossell, Universitat Internacional de Catalunya
- Investigators
- Andreu Puigdollers, Study director, Chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735394
- Sponsor's protocol ID
- ORT-ECL-2013-03
- Status last verified
- Nov 2018
- First submitted
- 13 Oct 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All identified data of individuals measurements will be available
Publications
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.
PubMed 19811580Zweers 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.
PubMed 24836578
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labial Gingival and Osseous Thickness of Upper and Lower Incisors in Thick and Thin Biotypes
- ClinicalTrials.gov ID
- NCT03735394
- Acronym / sponsor ID
- ORT-ECL-2013-03
- Conditions
- Gingival Recession
- Keywords
- Gingival thickness, gingival biotype, gingival recession, maxilla, mandible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gingival Biotype | Experimental | Diagnostic Test: ultrasonic probeA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- gingival inflammation
- daily smokers
- patients taking drugs that causes gingival inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonic probeAlso: tangential x-rayapply 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. | Diagnostic test | Gingival Biotype |
Primary outcome
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
2 secondary outcomes
Differences in tissue thickness according to gender
Time frame: 1 day
thickness biotype differences
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Background: PubMed 19811580Eghbali 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.
- Background: PubMed 24836578Zweers 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.
- Individual participant dataSharing planned: Yes. All identified data of individuals measurements will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreu Puigdollers study director
Chairman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonic probe in people with Gingival Recession, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare between maxilla and mandibular biotype measured with the periodontal probe (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03735394, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.