Gingival RecessionNCT05478148
TECHNIQUES USED IN EVALUATION OF GINGIVAL PHENOTYPE
A study testing Gingival thickness in people with Gingival Recession, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the 4 different techniques used in clinical measurement of gingival phenotype. 1) Tranclusency of UNC-15 Periodontal Probe, 2) Transgingival probing with Endodontic file (#20), 3)Transgingival Probing with Modified Florida Probe and 4) Translucency Colorvue Biotype Probe. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Gingival thickness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2021to 25 May 2022
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals,
- Periodontal healthy individuals with a whole mouth plaque score of 15% and a whole mouth bleeding score of less than 15%,
- Individuals who have not undergone periodontal treatment (subgingival curettage, gingivectomy, crown lengthening, etc.) in the last 6 months,
- Absence of dental compensations of skeletal malocclusion.
Who cannot join
- Individuals who smoke and have a history of smoking,
- Individuals who have undergone orthodontic treatment,
- Individuals using drugs that may cause gingival hyperplasia (immunosuppressive drugs, calcium channel blockers, anticonvulsant drugs, etc.)
- Individuals who are in pregnancy or lactation period,
- Presence of structural defects, crowns or large restorations in the maxillary anterior teeth to be measured,
- The presence of missing or supernumerary teeth in the maxillary anterior teeth to be measured,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Faculty of Dentistry
Samsun, 55200
About this study
Official title: COMPARISON OF THE CONVENTIONAL AND MODERN TECHNIQUES USED IN CLINICAL EVALUATION AND CLASSIFICATION OF THE GINGIVAL PHENOTYPE.
This study evaluates the 4 different techniques used in clinical measurement of gingival phenotype. 1) Tranclusency of UNC-15 Periodontal Probe, 2) Transgingival probing with Endodontic file (#20), 3)Transgingival Probing with Modified Florida Probe and 4) Translucency Colorvue Biotype Probe.
The aim of our study is to evaluate the reliability and applicability of the current examination methods recommended in order to improve the deficiencies of the traditional examination methods used in the evaluation of the gingival phenotype.
- Conditions
- Gingival Recession
- Being tested
- Gingival thickness
- Keywords
- gingival phenotype, gingival thickness
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival thicknessDevice
After the classification the phenotype, gingival thickness was measured with Endodontic File and Modified Florida Probe from the 3 different points. First point was the probing depth level, second one was 1mm apical to this level and third one from the 2mm apical to probing depth.
| Study group | Role | What they receive |
|---|---|---|
| Gingival phenotype | Experimental | A Periodontal probe was used to differentiate between thick and thin phenotypes and Color coded Biotype Probe was used to classified the phenotype as thin, moderate, thick and very thick phenotypes. Endodontic File and Florida probe were used to measure the gingival thickness. Receives: Device: Gingival thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and reliability of techniques
Comparison between the conventional techniques(Periodontal probe and Endodontic file) and modern techniques(Colorvue Biotype Probe and Modified Florida Probe) in terms of reliability and feasibility.
Measured: 1 day
Secondary outcomes (1)
The amount of gingival thickness and the width of the keratinized tissue
To determine the cut-off dimensions by evaluating the gingival thickness at 3 different points.
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 posted28 Jul 2022
- Study start25 Apr 2021
- Primary completion30 Mar 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RASUL GULIYEV, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478148
- Sponsor's protocol ID
- PYO.DIS.1904.21.008
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE CONVENTIONAL AND MODERN TECHNIQUES USED IN CLINICAL EVALUATION AND CLASSIFICATION OF THE GINGIVAL PHENOTYPE.
- ClinicalTrials.gov ID
- NCT05478148
- Acronym / sponsor ID
- PYO.DIS.1904.21.008
- Conditions
- Gingival Recession
- Keywords
- gingival phenotype, gingival thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 28 Jul 2022 (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 study evaluates the 4 different techniques used in clinical measurement of gingival phenotype. 1) Tranclusency of UNC-15 Periodontal Probe, 2) Transgingival probing with Endodontic file (#20), 3)Transgingival Probing with Modified Florida Probe and 4) Translucency Colorvue Biotype Probe.
The aim of our study is to evaluate the reliability and applicability of the current examination methods recommended in order to improve the deficiencies of the traditional examination methods used in the evaluation of the gingival phenotype.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gingival phenotype | Experimental | Device: Gingival thicknessA Periodontal probe was used to differentiate between thick and thin phenotypes and Color coded Biotype Probe was used to classified the phenotype as thin, moderate, thick and very thick phenotypes. Endodontic File and Florida probe were used to measure the gingival thickness. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Systemically healthy individuals,
- Periodontal healthy individuals with a whole mouth plaque score of 15% and a whole mouth bleeding score of less than 15%,
- Individuals who have not undergone periodontal treatment (subgingival curettage, gingivectomy, crown lengthening, etc.) in the last 6 months,
- Absence of dental compensations of skeletal malocclusion.
Key exclusion criteria (6 listed)
- Individuals who smoke and have a history of smoking,
- Individuals who have undergone orthodontic treatment,
- Individuals using drugs that may cause gingival hyperplasia (immunosuppressive drugs, calcium channel blockers, anticonvulsant drugs, etc.)
- Individuals who are in pregnancy or lactation period,
- Presence of structural defects, crowns or large restorations in the maxillary anterior teeth to be measured,
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 |
|---|---|---|
| Gingival thicknessAfter the classification the phenotype, gingival thickness was measured with Endodontic File and Modified Florida Probe from the 3 different points. First point was the probing depth level, second one was 1mm apical to this level and third one from the 2mm apical to probing depth. | Device | Gingival phenotype |
Primary outcome
Feasibility and reliability of techniques
Time frame: 1 day
Comparison between the conventional techniques(Periodontal probe and Endodontic file) and modern techniques(Colorvue Biotype Probe and Modified Florida Probe) in terms of reliability and feasibility.
1 secondary outcome
The amount of gingival thickness and the width of the keratinized tissue
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 1 Aug 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival thickness in people with Gingival Recession, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 1 Aug 2022. 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 Turkey (Türkiye). 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?
Feasibility and reliability of techniques (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2022.