Thin Gingival BiotypeNCT06964529
Evaluation of the Effects of I-PRF and C-PRF on Gingival Phenotype
A study testing Concentrated PRF and Injectable PRF in people with Thin Gingival Biotype and Thin Gingiva, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) and concentrated platelet-rich fibrin (C-PRF) on gingival phenotype in patients undergoing mucogingival surgery with the VISTA technique. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Thin Gingival Biotype, Thin Gingiva
- What is being tested?
- Concentrated PRF and Injectable PRF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2025to 15 Jun 2026
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy individuals (ASA I) Age between 18 and 45 years Non-smokers Gingival thickness ≤ 0.8 mm in the mandibular anterior region No restorations, missing teeth, or supernumerary teeth in the mandibular anterior region Full-mouth plaque index (PI) < 15% Full-mouth bleeding on probing (BOP) < 15%
Who cannot join
- Presence of systemic disease or coagulation disorders Use of antibiotics or anti-inflammatory drugs within the last 3 months Smoking History of bruxism Pregnancy or lactation Ongoing orthodontic treatment Use of medications affecting gingival phenotype (e.g., calcium channel blockers, anticonvulsants) Presence of infection, lesion, or trauma at the surgical site History of periodontal surgery in the relevant area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Injectable Versus Concentrated Platelet-Rich Fibrin for Gingival Phenotype Modification: A Randomized Clinical Trial
This clinical trial aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) and concentrated platelet-rich fibrin (C-PRF) on gingival phenotype in patients undergoing mucogingival surgery with the VISTA technique. Changes in gingival thickness and width of keratinized gingiva will be assessed using transgingival methods.
Read the detailed description
The study is designed as a randomized controlled clinical trial including 30 patients, divided into two groups: I-PRF and C-PRF. All participants receive a mucogingival procedure using the VISTA technique followed by four sessions of PRF injections (one during surgery and three at 10-day intervals). The primary outcomes are changes in gingival thickness and the width of keratinized gingiva, measured manually at baseline, 1 month, 3 months, 6 months. and 12 months. The aim is to compare the effectiveness of I-PRF and C-PRF on soft tissue enhancement.
- Conditions
- Thin Gingival Biotype, Thin Gingiva
- Being tested
- Concentrated PRF, Injectable PRF
- Keywords
- C-PRF, I-PRF, VISTA Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated PRFBiological
Also called C-PRF
Injectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions at 10-day intervals).
Injectable PRFBiological
Also called I-PRF
Injectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions at 10-day intervals).
| Study group | Role | What they receive |
|---|---|---|
| C-PRF Group | Experimental | Concentrated platelet-rich fibrin was prepared using horizontal centrifugation and injected at 4 time points (once during the VISTA procedure, and 3 additional times at 10-day intervals). Receives: Biological: Concentrated PRF |
| I-PRF Group | Experimental | Injectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions). Receives: Biological: Injectable PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival thickness
Gingival thickness will be measured manually (using a spreader) to assess the effect of I-PRF and C-PRF over time.
Measured: Baseline, 1 month, 3 months, 6 months and 12 months.
Secondary outcomes (1)
Change in width of keratinized gingiva
The width of keratinized gingiva will be measured manually using a periodontal probe to evaluate the soft tissue augmentation potential of C-PRF and I-PRF.
Measured: Baseline, 1 month, 3 months, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start11 Feb 2025
- Primary completion18 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin Gingival BiotypeStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel design comparing the effects of I-PRF and C-PRF on gingival phenotype using VISTA technique.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ümmü Gülsüm ÖĞE, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964529
- Sponsor's protocol ID
- IU 2024/74
- Status last verified
- Oct 2026
- First submitted
- 1 May 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Versus Concentrated Platelet-Rich Fibrin for Gingival Phenotype Modification: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06964529
- Acronym / sponsor ID
- IU 2024/74
- Conditions
- Thin Gingival Biotype, Thin Gingiva
- Keywords
- C-PRF, I-PRF, VISTA Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 9 May 2025 (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 trial aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) and concentrated platelet-rich fibrin (C-PRF) on gingival phenotype in patients undergoing mucogingival surgery with the VISTA technique. Changes in gingival thickness and width of keratinized gingiva will be assessed using transgingival methods.
Detailed description
The study is designed as a randomized controlled clinical trial including 30 patients, divided into two groups: I-PRF and C-PRF. All participants receive a mucogingival procedure using the VISTA technique followed by four sessions of PRF injections (one during surgery and three at 10-day intervals). The primary outcomes are changes in gingival thickness and the width of keratinized gingiva, measured manually at baseline, 1 month, 3 months, 6 months. and 12 months. The aim is to compare the effectiveness of I-PRF and C-PRF on soft tissue enhancement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-arm parallel design comparing the effects of I-PRF and C-PRF on gingival phenotype using VISTA technique.
| Arm | Type | Receives |
|---|---|---|
| C-PRF Group | Experimental | Biological: Concentrated PRFConcentrated platelet-rich fibrin was prepared using horizontal centrifugation and injected at 4 time points (once during the VISTA procedure, and 3 additional times at 10-day intervals). |
| I-PRF Group | Experimental | Biological: Injectable PRFInjectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy individuals (ASA I) Age between 18 and 45 years Non-smokers Gingival thickness ≤ 0.8 mm in the mandibular anterior region No restorations, missing teeth, or supernumerary teeth in the mandibular anterior region Full-mouth plaque index (PI) < 15% Full-mouth bleeding on probing (BOP) < 15%
Key exclusion criteria (1 listed)
- Presence of systemic disease or coagulation disorders Use of antibiotics or anti-inflammatory drugs within the last 3 months Smoking History of bruxism Pregnancy or lactation Ongoing orthodontic treatment Use of medications affecting gingival phenotype (e.g., calcium channel blockers, anticonvulsants) Presence of infection, lesion, or trauma at the surgical site History of periodontal surgery in the relevant area
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 |
|---|---|---|
| Concentrated PRFAlso: C-PRFInjectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions at 10-day intervals). | Biological | C-PRF Group |
| Injectable PRFAlso: I-PRFInjectable platelet-rich fibrin was prepared using low-speed centrifugation and injected using the same protocol as C-PRF (1 surgical + 3 injection sessions at 10-day intervals). | Biological | I-PRF Group |
Primary outcome
Change in gingival thickness
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months.
Gingival thickness will be measured manually (using a spreader) to assess the effect of I-PRF and C-PRF over time.
1 secondary outcome
Change in width of keratinized gingiva
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months.
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 20 Oct 2026.
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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 Concentrated PRF and Injectable PRF in people with Thin Gingival Biotype and Thin Gingiva, run by Inonu 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 1 inclusion and 1 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 20 Oct 2026. 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?
Change in gingival thickness (time frame: Baseline, 1 month, 3 months, 6 months and 12 months.). 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 20 Oct 2026.