Gingival DiseasesNCT07591142
Titanium-prepared Platelet-rich Fibrin for Treatment of Gingival Recession Using the VISTA Technique
A study testing Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA Technique and Connective Tissue Graft (CTG) with VISTA Technique in people with Gingival Diseases and Gingival Recession, run by Arab International University at 1 site in Syria.
Trial summary
This split-mouth randomized clinical trial aims to compare the effectiveness of titanium-prepared platelet-rich fibrin (T-PRF) and connective tissue graft (CTG) in the treatment of Miller Class I and II gingival recession using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gingival Diseases, Gingival Recession
- What is being tested?
- Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA Technique and Connective Tissue Graft (CTG) with VISTA Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 12 Aug 2025to 25 Apr 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy
- Bilateral gingival recession
- Good oral hygiene
Who cannot join
- Smokers
- Pregnant/lactating women
- Systemic diseases affecting healing
- Previous surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Titanium-prepared Platelet-rich Fibrin Versus Connective Tissue Graft in Gingival Recession Treatment: a Split-mouth Randomized Clinical Trial
This split-mouth randomized clinical trial aims to compare the effectiveness of titanium-prepared platelet-rich fibrin (T-PRF) and connective tissue graft (CTG) in the treatment of Miller Class I and II gingival recession using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique. Twenty systemically healthy adult participants with bilateral gingival recession defects will receive both interventions, with one side randomly assigned to T-PRF and the contralateral side assigned to CTG. Clinical outcomes including recession depth, attached gingival width, probing depth, relative attachment level, healing, and patient satisfaction will be evaluated over a 6-month follow-up period.
Read the detailed description
Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, resulting in root exposure, dentin hypersensitivity, esthetic concerns, and increased susceptibility to root caries. Connective tissue grafts (CTG) are widely considered the gold standard for root coverage procedures due to their predictable clinical outcomes. However, CTG requires harvesting tissue from a secondary surgical donor site, which may increase postoperative discomfort and patient morbidity.
Titanium-prepared platelet-rich fibrin (T-PRF) is a second-generation autologous platelet concentrate prepared using titanium tubes, which may enhance fibrin network quality and improve soft tissue healing and regeneration. T-PRF has been proposed as a less invasive alternative to CTG in periodontal plastic surgery.
The present study is designed as a split-mouth randomized controlled clinical trial to compare T-PRF and CTG in the treatment of bilateral Miller Class I and II gingival recession defects using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique. Twenty systemically healthy adult participants with symmetrical gingival recession defects will be enrolled. Each participant will receive both interventions: one side of the mouth will be randomly assigned to treatment with VISTA combined with CTG, while the contralateral side will receive VISTA combined with T-PRF.
Randomization will be performed using a computer-generated allocation sequence prepared by an independent investigator. Due to the nature of the interventions, operator blinding is not feasible; however, all clinical measurements and outcome assessments will be conducted by a blinded examiner.
Clinical parameters including gingival recession depth, attached gingival width, probing depth, and relative attachment level will be measured at baseline, 3 months, and 6 months postoperatively using a UNC-15 periodontal probe. Early wound healing will be assessed at 1, 2, and 4 weeks using a healing index. Patient-reported satisfaction and postoperative outcomes will be evaluated using a visual analog scale (VAS).
The study aims to determine whether T-PRF can provide comparable clinical and patient-centered outcomes to CTG while reducing the morbidity associated with donor site harvesting.
- Conditions
- Gingival Diseases, Gingival Recession
- Being tested
- Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA Technique, Connective Tissue Graft (CTG) with VISTA Technique
- Keywords
- Titanium-prepared platelet-rich fibrin, Connective tissue graft, VISTA technique, Root coverage surgery
- Medical subject headings
- Gingival Diseases, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA TechniqueProcedure or surgery
The gingival recession defects assigned to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with titanium-prepared platelet-rich fibrin (T-PRF). T-PRF membranes will be prepared from the participant's autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled flap.
Connective Tissue Graft (CTG) with VISTA TechniqueProcedure or surgery
The gingival recession defects assigned to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with an autogenous connective tissue graft (CTG). The graft will be harvested from the palatal donor site and positioned beneath the tunneled gingival tissue to achieve root coverage and soft tissue augmentation.
| Study group | Role | What they receive |
|---|---|---|
| VISTA + Titanium-Prepared Platelet-Rich Fibrin (T-PRF) | Experimental | Sites allocated to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with titanium-prepared platelet-rich fibrin (T-PRF). T-PRF membranes will be prepared from autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled gingival tissue. Receives: Procedure: Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA Technique |
| VISTA + Connective Tissue Graft (CTG) | Active comparator | Sites allocated to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with an autogenous connective tissue graft (CTG) harvested from the palatal donor site and placed beneath the tunneled gingival tissue for root coverage. Receives: Procedure: Connective Tissue Graft (CTG) with VISTA Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Recession Depth
Change in gingival recession depth measured in millimeters (mm) from the cementoenamel junction to the free gingival margin using a UNC-15 periodontal probe. Lower values indicate better root coverage outcomes.
Measured: Baseline, 3 months, and 6 months postoperatively.
Width of Attached Gingiva
Change in the width of attached gingiva measured in millimeters (mm) using a UNC-15 periodontal probe. Higher values indicate improved gingival tissue augmentation and periodontal stability.
Measured: Baseline, 3 months, and 6 months postoperatively.
Secondary outcomes (5)
Periodontal Probing Depth
Change in periodontal probing depth measured in millimeters (mm) using a UNC-15 periodontal probe at treated sites. Lower values indicate better periodontal health.
Measured: Baseline, 3 months, and 6 months postoperatively.
Relative Clinical Attachment Level
Change in relative clinical attachment level measured in millimeters (mm) using a UNC-15 periodontal probe. Lower values indicate improved periodontal attachment.
Measured: Baseline, 3 months, and 6 months postoperatively.
Early Wound Healing Index
Early wound healing assessed clinically using the Early Healing Index (EHI). The scale ranges from 1 to 5, where:
1 = Complete flap closure without fibrin line (best healing) 5 = Incomplete flap closure with complete tissue necrosis (worst healing)
Lower scores indicate better healing outcomes.
Measured: 1 week, 2 weeks, and 4 weeks postoperatively.
Patient Satisfaction
Patient satisfaction assessed using a Visual Analog Scale (VAS). The scale ranges from 0 to 10, where:
0 = Completely dissatisfied 10 = Completely satisfied
Higher scores indicate greater patient satisfaction with the treatment outcome.
Measured: 3 months and 6 months postoperatively.
Postoperative Pain
Postoperative pain assessed using a Visual Analog Scale (VAS). The scale ranges from 0 to 10, where:
0 = No pain 10 = Worst imaginable pain
Lower scores indicate less postoperative pain and discomfort.
Measured: 1 week and 2 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start12 Aug 2025
- Primary completion12 Jan 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gingival DiseasesStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab International University
- Sponsor type
- University, hospital or other
- Collaborators
- Damascus University
- Responsible party
- Sponsor
- Investigators
- Rania Daadoush, DDs, Principal investigator, Damascus UniversityTarek Qasem, PhD, Study chair, Damascus UniversitySaleh Al Kurdi, PhD, Study director, Arab International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591142
- Sponsor's protocol ID
- DN-14072025-3109
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Yaprak E, Toker H, Firatli E. A novel platelet concentrate: titanium-prepared platelet-rich fibrin. Biomed Res Int. 2014;2014:209548. doi: 10.1155/2014/209548. Epub 2014 Jan 21.
PubMed 24563860Miller PD Jr. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. No abstract available.
PubMed 3858267Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
PubMed 21507033Chambrone L, Sukekava F, Araujo MG, Pustiglioni FE, Chambrone LA, Lima LA. Root-coverage procedures for the treatment of localized recession-type defects: a Cochrane systematic review. J Periodontol. 2010 Apr;81(4):452-78. doi: 10.1902/jop.2010.090540.
PubMed 20367089Abdelhaleem M, Saleh W, Elmeadawy S. Treatment of gingival recession with vestibular incision subperiosteal tunnel access and advanced platelet-rich fibrin. BMC Oral Health. 2025 Jan 14;25(1):63. doi: 10.1186/s12903-024-05398-w.
PubMed 39806320
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titanium-prepared Platelet-rich Fibrin Versus Connective Tissue Graft in Gingival Recession Treatment: a Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07591142
- Acronym / sponsor ID
- DN-14072025-3109
- Conditions
- Gingival Diseases, Gingival Recession
- Keywords
- Titanium-prepared platelet-rich fibrin, Connective tissue graft, VISTA technique, Root coverage surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Arab International UniversityUniversity, hospital or other
- Collaborators
- Damascus University
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 15 May 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 split-mouth randomized clinical trial aims to compare the effectiveness of titanium-prepared platelet-rich fibrin (T-PRF) and connective tissue graft (CTG) in the treatment of Miller Class I and II gingival recession using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique. Twenty systemically healthy adult participants with bilateral gingival recession defects will receive both interventions, with one side randomly assigned to T-PRF and the contralateral side assigned to CTG. Clinical outcomes including recession depth, attached gingival width, probing depth, relative attachment level, healing, and patient satisfaction will be evaluated over a 6-month follow-up period.
Detailed description
Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, resulting in root exposure, dentin hypersensitivity, esthetic concerns, and increased susceptibility to root caries. Connective tissue grafts (CTG) are widely considered the gold standard for root coverage procedures due to their predictable clinical outcomes. However, CTG requires harvesting tissue from a secondary surgical donor site, which may increase postoperative discomfort and patient morbidity.
Titanium-prepared platelet-rich fibrin (T-PRF) is a second-generation autologous platelet concentrate prepared using titanium tubes, which may enhance fibrin network quality and improve soft tissue healing and regeneration. T-PRF has been proposed as a less invasive alternative to CTG in periodontal plastic surgery.
The present study is designed as a split-mouth randomized controlled clinical trial to compare T-PRF and CTG in the treatment of bilateral Miller Class I and II gingival recession defects using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique. Twenty systemically healthy adult participants with symmetrical gingival recession defects will be enrolled. Each participant will receive both interventions: one side of the mouth will be randomly assigned to treatment with VISTA combined with CTG, while the contralateral side will receive VISTA combined with T-PRF.
Randomization will be performed using a computer-generated allocation sequence prepared by an independent investigator. Due to the nature of the interventions, operator blinding is not feasible; however, all clinical measurements and outcome assessments will be conducted by a blinded examiner.
Clinical parameters including gingival recession depth, attached gingival width, probing depth, and relative attachment level will be measured at baseline, 3 months, and 6 months postoperatively using a UNC-15 periodontal probe. Early wound healing will be assessed at 1, 2, and 4 weeks using a healing index. Patient-reported satisfaction and postoperative outcomes will be evaluated using a visual analog scale (VAS).
The study aims to determine whether T-PRF can provide comparable clinical and patient-centered outcomes to CTG while reducing the morbidity associated with donor site harvesting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISTA + Titanium-Prepared Platelet-Rich Fibrin (T-PRF) | Experimental | Procedure: Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA TechniqueSites allocated to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with titanium-prepared platelet-rich fibrin (T-PRF). T-PRF membranes will be prepared from autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled gingival tissue. |
| VISTA + Connective Tissue Graft (CTG) | Active comparator | Procedure: Connective Tissue Graft (CTG) with VISTA TechniqueSites allocated to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with an autogenous connective tissue graft (CTG) harvested from the palatal donor site and placed beneath the tunneled gingival tissue for root coverage. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy
- Bilateral gingival recession
- Good oral hygiene
Key exclusion criteria (4 listed)
- Smokers
- Pregnant/lactating women
- Systemic diseases affecting healing
- Previous surgery
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 |
|---|---|---|
| Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA TechniqueThe gingival recession defects assigned to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with titanium-prepared platelet-rich fibrin (T-PRF). T-PRF membranes will be prepared from the participant's autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled flap. | Procedure or surgery | VISTA + Titanium-Prepared Platelet-Rich Fibrin (T-PRF) |
| Connective Tissue Graft (CTG) with VISTA TechniqueThe gingival recession defects assigned to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with an autogenous connective tissue graft (CTG). The graft will be harvested from the palatal donor site and positioned beneath the tunneled gingival tissue to achieve root coverage and soft tissue augmentation. | Procedure or surgery | VISTA + Connective Tissue Graft (CTG) |
Primary outcome
Gingival Recession Depth
Time frame: Baseline, 3 months, and 6 months postoperatively.
Change in gingival recession depth measured in millimeters (mm) from the cementoenamel junction to the free gingival margin using a UNC-15 periodontal probe. Lower values indicate better root coverage outcomes.
Width of Attached Gingiva
Time frame: Baseline, 3 months, and 6 months postoperatively.
Change in the width of attached gingiva measured in millimeters (mm) using a UNC-15 periodontal probe. Higher values indicate improved gingival tissue augmentation and periodontal stability.
5 secondary outcomes
Periodontal Probing Depth
Time frame: Baseline, 3 months, and 6 months postoperatively.
Relative Clinical Attachment Level
Time frame: Baseline, 3 months, and 6 months postoperatively.
Early Wound Healing Index
Time frame: 1 week, 2 weeks, and 4 weeks postoperatively.
Patient Satisfaction
Time frame: 3 months and 6 months postoperatively.
Postoperative Pain
Time frame: 1 week and 2 weeks postoperatively.
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 15 May 2026.
- Background: PubMed 24563860Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Yaprak E, Toker H, Firatli E. A novel platelet concentrate: titanium-prepared platelet-rich fibrin. Biomed Res Int. 2014;2014:209548. doi: 10.1155/2014/209548. Epub 2014 Jan 21.
- Background: PubMed 3858267Miller PD Jr. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. No abstract available.
- Background: PubMed 21507033Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
- Background: PubMed 20367089Chambrone L, Sukekava F, Araujo MG, Pustiglioni FE, Chambrone LA, Lima LA. Root-coverage procedures for the treatment of localized recession-type defects: a Cochrane systematic review. J Periodontol. 2010 Apr;81(4):452-78. doi: 10.1902/jop.2010.090540.
- Background: PubMed 39806320Abdelhaleem M, Saleh W, Elmeadawy S. Treatment of gingival recession with vestibular incision subperiosteal tunnel access and advanced platelet-rich fibrin. BMC Oral Health. 2025 Jan 14;25(1):63. doi: 10.1186/s12903-024-05398-w.
- 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.
Rania Daadoush, DDs principal investigator
Damascus University
Tarek Qasem, PhD study chair
Damascus University
Saleh Al Kurdi, PhD study director
Arab International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA Technique and Connective Tissue Graft (CTG) with VISTA Technique in people with Gingival Diseases and Gingival Recession, run by Arab International University at 1 site in Syria.
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 3 inclusion and 4 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 15 May 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 Syria. 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?
Gingival Recession Depth (time frame: Baseline, 3 months, and 6 months postoperatively.). The study lists 2 primary outcomes in all. 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 NCT07591142, which also lists 5 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 15 May 2026.