Thin Gingival BiotypeNCT07521527
i-PRF for Gingival Phenotype Modification
A study testing Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique in people with Thin Gingival Biotype, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This randomized split-mouth clinical trial aims to evaluate the effectiveness of injectable platelet-rich fibrin (i-PRF) in thickening thin gingival phenotype and improving soft tissue conditions around teeth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thin Gingival Biotype
- What is being tested?
- Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy individuals aged ≥18 years
- Non-smokers or light smokers (≤10 cigarettes per day)
- Individuals with full-mouth plaque score (FMPS) <15% and full-mouth bleeding score (FMBS) <15%
- Individuals with gingival thickness <0.8 mm in the mandibular anterior teeth to be treated
- Periodontally healthy individuals with probing depth (PD) ≤3 mm in the mandibular anterior teeth
- Absence of structural defects, crowns, or large restorations in the mandibular anterior teeth
Show all 9Show fewer
- Absence of missing or supernumerary teeth in the mandibular anterior region
- No history of blood-borne infectious diseases
- No systemic diseases or medical conditions
Who cannot join
- Individuals under 18 years of age
- Pregnancy or breastfeeding
- Presence of periodontal pockets >4 mm
- Presence of structural defects, crowns, or large restorations in the teeth
- Presence of systemic diseases or coagulation disorders
- Use of anticoagulant medications
Show all 9Show fewer
- Ongoing orthodontic treatment with active tooth movement
- Use or history of medications affecting periodontal tissues (e.g., immunosuppressive drugs, calcium channel blockers, anticonvulsants)
- History of periodontal surgery in the area to be treated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gingival Phenotype Thickening Using Injectable PRF Alone or Combined With a Semi-Surgical Approach: A Split-Mouth Study
This randomized split-mouth clinical trial aims to evaluate the effectiveness of injectable platelet-rich fibrin (i-PRF) in thickening thin gingival phenotype and improving soft tissue conditions around teeth.
Thin gingival tissue is an important risk factor for gingival recession and may negatively affect periodontal health and esthetic outcomes. This study investigates whether the use of i-PRF, obtained from the patient's own blood, can enhance gingival thickness and support tissue healing.
Read more
Following initial periodontal therapy, the procedure will be performed under local anesthesia. A minimally invasive approach will be applied to the gingival tissue, and i-PRF prepared from the patient's blood will be injected into the treatment area. The procedure will be repeated in multiple sessions at regular intervals. Patients will receive standard post-operative care and instructions.
Clinical parameters will be evaluated at follow-up visits, and gingival thickness will be measured using ultrasonography over a 6-month period.
Possible risks include mild pain, bleeding, infection, and temporary discomfort, all of which are manageable with routine clinical care.
This study is expected to contribute to the development of minimally invasive and biologically based treatment approaches, reduce the need for additional surgical procedures, and improve periodontal and esthetic outcomes.
- Conditions
- Thin Gingival Biotype
- Being tested
- Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique
- Keywords
- i-PRF, VISTA technique, Gingival Phenotype, Gingival thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive TechniqueProcedure or surgery
Injectable platelet-rich fibrin (i-PRF) will be prepared from the participant's venous blood using a low-speed centrifugation protocol without anticoagulants. The obtained liquid fibrin will be applied to gingival tissues with a thin phenotype.
After initial periodontal therapy, the procedure will be performed under local anesthesia using a minimally invasive semi-surgical approach. A small apical incision and gentle periosteal elevation will be performed to create space, followed by injection of i-PRF into the target area using a dental syringe.
The procedure will be repeated at 10-day intervals for a total of four sessions. This intervention aims to enhance gingival thickness and improve soft tissue quality through the biological effects of autologous platelet concentrates, including growth factor release and angiogenesis.
| Study group | Role | What they receive |
|---|---|---|
| Injectable Platelet-Rich Fibrin (i-PRF) Alone (control) | Active comparator | Not described Receives: Procedure: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique |
| Injectable Platelet-Rich Fibrin (i-PRF) with Minimally Invasive Technique (test) | Active comparator | Not described Receives: Procedure: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Thickness (Ultrasonographic Measurement)
Assessment of gingival thickness using ultrasonography to evaluate changes in soft tissue thickness. Measurements will be performed at baseline, 1 month, 3 months, and 6 months.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thin Gingival BiotypeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Tunali, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521527
- Sponsor's protocol ID
- OGU-EC-06-25
- Other IDs
- 2024-KAEK-15
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.
PubMed 31912532
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Phenotype Thickening Using Injectable PRF Alone or Combined With a Semi-Surgical Approach: A Split-Mouth Study
- ClinicalTrials.gov ID
- NCT07521527
- Acronym / sponsor ID
- OGU-EC-06-25
- Conditions
- Thin Gingival Biotype
- Keywords
- i-PRF, VISTA technique, Gingival Phenotype, Gingival thickness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 Apr 2026 (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 randomized split-mouth clinical trial aims to evaluate the effectiveness of injectable platelet-rich fibrin (i-PRF) in thickening thin gingival phenotype and improving soft tissue conditions around teeth.
Thin gingival tissue is an important risk factor for gingival recession and may negatively affect periodontal health and esthetic outcomes. This study investigates whether the use of i-PRF, obtained from the patient's own blood, can enhance gingival thickness and support tissue healing.
Following initial periodontal therapy, the procedure will be performed under local anesthesia. A minimally invasive approach will be applied to the gingival tissue, and i-PRF prepared from the patient's blood will be injected into the treatment area. The procedure will be repeated in multiple sessions at regular intervals. Patients will receive standard post-operative care and instructions.
Clinical parameters will be evaluated at follow-up visits, and gingival thickness will be measured using ultrasonography over a 6-month period.
Possible risks include mild pain, bleeding, infection, and temporary discomfort, all of which are manageable with routine clinical care.
This study is expected to contribute to the development of minimally invasive and biologically based treatment approaches, reduce the need for additional surgical procedures, and improve periodontal and esthetic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectable Platelet-Rich Fibrin (i-PRF) Alone (control) | Active comparator | Procedure: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique |
| Injectable Platelet-Rich Fibrin (i-PRF) with Minimally Invasive Technique (test) | Active comparator | Procedure: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Systemically healthy individuals aged ≥18 years
- Non-smokers or light smokers (≤10 cigarettes per day)
- Individuals with full-mouth plaque score (FMPS) <15% and full-mouth bleeding score (FMBS) <15%
- Individuals with gingival thickness <0.8 mm in the mandibular anterior teeth to be treated
- Periodontally healthy individuals with probing depth (PD) ≤3 mm in the mandibular anterior teeth
Key exclusion criteria (9 listed)
- Individuals under 18 years of age
- Pregnancy or breastfeeding
- Presence of periodontal pockets >4 mm
- Presence of structural defects, crowns, or large restorations in the teeth
- Presence of systemic diseases or coagulation disorders
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 |
|---|---|---|
| Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive TechniqueInjectable platelet-rich fibrin (i-PRF) will be prepared from the participant's venous blood using a low-speed centrifugation protocol without anticoagulants. The obtained liquid fibrin will be applied to gingival tissues with a thin phenotype. After initial periodontal therapy, the procedure will be performed under local anesthesia using a minimally invasive semi-surgical approach. A small apical incision and gentle periosteal elevation will be performed to create space, followed by injection of i-PRF into the target area using a dental syringe. The procedure will be repeated at 10-day intervals for a total of four sessions. This intervention aims to enhance gingival thickness and improve soft tissue quality through the biological effects of autologous platelet concentrates, including growth factor release and angiogenesis. | Procedure or surgery | Injectable Platelet-Rich Fibrin (i-PRF) Alone (control), Injectable Platelet-Rich Fibrin (i-PRF) with Minimally Invasive Technique (test) |
Primary outcome
Gingival Thickness (Ultrasonographic Measurement)
Time frame: 6 month
Assessment of gingival thickness using ultrasonography to evaluate changes in soft tissue thickness. Measurements will be performed at baseline, 1 month, 3 months, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 31912532Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.
- Individual participant dataSharing planned: No
Related trials for Thin Gingival Biotype
Not yet recruiting
Efficacy of Microneedling With Hyaluronic Acid Injection for Gingival Augmentation in Thin Gingival Phenotype
Thin Gingival Biotype
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 Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique in people with Thin Gingival Biotype, run by Çanakkale Onsekiz Mart 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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Gingival Thickness (Ultrasonographic Measurement) (time frame: 6 month). 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 NCT07521527, which also lists 1 linked publication.
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 13 Apr 2026.