Gingival RecessionagrNCT06502782
Areal and Linear Comparison of Gingival Recession
An observational study of Gingival Recession, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Recent advances in digital technology have led to the emergence of precise methods for measuring gingival recession and tissue thickness. This study aimed to compare digital measurement methods and conventional periodontal probe measurements for the assessment of gingival recession influenced by the gingival… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- digital assesment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2022to 12 Apr 2024
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study included 128 gingival recessions at 128 sites in 28 systemically healthy patients aged 18-45 years old. The patients were divided into two groups according to the thickness of the gingiva in the teeth with gingival recession.
Who may be able to join
None listed.
Who cannot join
- Patients with a history of radiotherapy,
- Patients with chemotherapy,
- Immunosuppressive use,
- Tobacco use,
- Smoking,
- Patients with labially exposed teeth and teeth with prominent root protrusions,
Show all 10Show fewer
- Pregnancy and lactation,
- Patients with uncontrolled diabetes,
- Patients with postorthodontic extractions,
- Patients with gingival recession, .Patients with gingival enlargement caused by piercing and nail-biting habits.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University
Bolu, Bolu, 14030
About this study
Official title: Areal and Linear Comparison of the Effect of Gingival Phenotype on Gingival Recession
Recent advances in digital technology have led to the emergence of precise methods for measuring gingival recession and tissue thickness. This study aimed to compare digital measurement methods and conventional periodontal probe measurements for the assessment of gingival recession influenced by the gingival phenotype.
This study involved 128 gingival recession sites from 28 systemically healthy patients aged 18-45 years. The participants were categorized into two groups on the basis of gingival thickness. The plaque index, gingival index, probing depth, clinical attachment level, gingival recession depth, and gingival recession width, and keratinized gingival thickness and width were measured using a manual periodontal probe and an intraoral optical surface scanner. Statistical analysis was performed with nonparametric tests because the data were not normally distributed. P<0.05 indicated statistical significanct.
- Conditions
- Gingival Recession
- Being tested
- digital assesment
- Keywords
- Gingiva, Gingival recession, Screening
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital assesmentDiagnostic test
Gingival recession sites were scanned with an intraoral optical surface scanner, and STL images were recorded. The images were imported into image analysis software. The depth, width and area of gingival recession were calculated using Autocat program.
| Study group | Role | What they receive |
|---|---|---|
| Thin phenotype | A thickness of 1 mm or less is classified as thin gingival tissue. Receives: Diagnostic Test: digital assesment | |
| Thick phenotype | A thickness of more than 1 mm is classified as thick gingival tissue. Receives: Diagnostic Test: digital assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratinized gingival thickness
Keratinized gingival thickness refers to the vertical measurement of the gingival tissue that extends from the free gingival margin to the mucogingival junction, characterized by a keratinized epithelial layer which provides enhanced protection and stability to the underlying periodontal structures.
Measured: Baseline
keratinized gingival width
Keratinized gingival width refers to the horizontal dimension of the gingival tissue that is keratinized, measured from the free gingival margin to the mucogingival junction.
Measured: Baseline
Gingival recession depth
Gingival recession is the apical migration of the gingival margin away from the cemento-enamel junction (CEJ), resulting in the exposure of the root surface of a tooth.
Measured: Baseline
Gingival recession width
Gingival recession width refers to the horizontal measurement from the exposed cemento-enamel junction (CEJ) to the apical point of the gingival margin, indicating the extent of root surface exposure.
Measured: Baseline
Secondary outcomes (5)
Plaque index
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth
Measured: Baseline
Gingival index
This measurement is based on the presence or absence of bleeding on gentle probing
Measured: Baseline
Bleeding on probing
Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements.
Measured: Baseline
Periodontal pocket depth
A pathologically deepened gingival sulcus around a tooth at the gingival margin.
Measured: Baseline
Clinical attachment level
CAL is calculated by subtracting the gingival margin level from the probing depth.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start12 Nov 2022
- Primary completion12 Nov 2023
- Study completion12 Apr 2024
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.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba ŞAHİN, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502782
- Sponsor's protocol ID
- 2022/288
- Acronym
- agr
- Status last verified
- Feb 2025
- First submitted
- 9 Jul 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Areal and Linear Comparison of the Effect of Gingival Phenotype on Gingival Recession
- ClinicalTrials.gov ID
- NCT06502782
- Acronym / sponsor ID
- agr / 2022/288
- Conditions
- Gingival Recession
- Keywords
- Gingiva, Gingival recession, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 16 Jul 2024 (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.
Recent advances in digital technology have led to the emergence of precise methods for measuring gingival recession and tissue thickness. This study aimed to compare digital measurement methods and conventional periodontal probe measurements for the assessment of gingival recession influenced by the gingival phenotype.
This study involved 128 gingival recession sites from 28 systemically healthy patients aged 18-45 years. The participants were categorized into two groups on the basis of gingival thickness. The plaque index, gingival index, probing depth, clinical attachment level, gingival recession depth, and gingival recession width, and keratinized gingival thickness and width were measured using a manual periodontal probe and an intraoral optical surface scanner. Statistical analysis was performed with nonparametric tests because the data were not normally distributed. P<0.05 indicated statistical significanct.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thin phenotype | – | Diagnostic Test: digital assesmentA thickness of 1 mm or less is classified as thin gingival tissue. |
| Thick phenotype | – | Diagnostic Test: digital assesmentA thickness of more than 1 mm is classified as thick gingival tissue. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study included 128 gingival recessions at 128 sites in 28 systemically healthy patients aged 18-45 years old. The patients were divided into two groups according to the thickness of the gingiva in the teeth with gingival recession.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Patients with a history of radiotherapy,
- Patients with chemotherapy,
- Immunosuppressive use,
- Tobacco use,
- Smoking,
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 |
|---|---|---|
| digital assesmentGingival recession sites were scanned with an intraoral optical surface scanner, and STL images were recorded. The images were imported into image analysis software. The depth, width and area of gingival recession were calculated using Autocat program. | Diagnostic test | Thick phenotype, Thin phenotype |
Primary outcome
keratinized gingival thickness
Time frame: Baseline
Keratinized gingival thickness refers to the vertical measurement of the gingival tissue that extends from the free gingival margin to the mucogingival junction, characterized by a keratinized epithelial layer which provides enhanced protection and stability to the underlying periodontal structures.
keratinized gingival width
Time frame: Baseline
Keratinized gingival width refers to the horizontal dimension of the gingival tissue that is keratinized, measured from the free gingival margin to the mucogingival junction.
Gingival recession depth
Time frame: Baseline
Gingival recession is the apical migration of the gingival margin away from the cemento-enamel junction (CEJ), resulting in the exposure of the root surface of a tooth.
Gingival recession width
Time frame: Baseline
Gingival recession width refers to the horizontal measurement from the exposed cemento-enamel junction (CEJ) to the apical point of the gingival margin, indicating the extent of root surface exposure.
5 secondary outcomes
Plaque index
Time frame: Baseline
Gingival index
Time frame: Baseline
Bleeding on probing
Time frame: Baseline
Periodontal pocket depth
Time frame: Baseline
Clinical attachment level
Time frame: Baseline
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 4 Feb 2025.
- 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?
An observational study of Gingival Recession, run by Abant Izzet Baysal 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 0 inclusion and 10 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 4 Feb 2025. 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?
keratinized gingival thickness (time frame: Baseline). The study lists 4 primary outcomes in all. 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 4 Feb 2025.