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NCT Number: NCT07591142

Titanium-prepared Platelet-rich Fibrin for Treatment of Gingival Recession Using the VISTA Technique

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.

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Key information

Conditions

Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Medicine

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systemically healthy
  • Bilateral gingival recession
  • Good oral hygiene

Exclusion criteria

  • Smokers
  • Pregnant/lactating women
  • Systemic diseases affecting healing
  • Previous surgery

Treatment and study plan

Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA Technique

Procedure

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 Technique

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Periodontal Probing Depth

    Time frame: Baseline, 3 months, and 6 months postoperatively.

    Change in periodontal probing depth measured in millimeters (mm) using a UNC-15 periodontal probe at treated sites. Lower values indicate better periodontal health.

  2. Relative Clinical Attachment Level

    Time frame: Baseline, 3 months, and 6 months postoperatively.

    Change in relative clinical attachment level measured in millimeters (mm) using a UNC-15 periodontal probe. Lower values indicate improved periodontal attachment.

  3. Early Wound Healing Index

    Time frame: 1 week, 2 weeks, and 4 weeks postoperatively.

    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.

  4. Patient Satisfaction

    Time frame: 3 months and 6 months postoperatively.

    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.

  5. Postoperative Pain

    Time frame: 1 week and 2 weeks postoperatively.

    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.

Sponsors and collaborators

Lead sponsor

Arab International University

Other

Collaborators

  • Damascus University

Registry information

Official study title

Titanium-prepared Platelet-rich Fibrin Versus Connective Tissue Graft in Gingival Recession Treatment: a Split-mouth Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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