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NCT Number: NCT07521527

i-PRF for Gingival Phenotype Modification

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Thin Gingival Biotype

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çanakkale Onsekiz Mart University

Çanakkale, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • Absence of missing or supernumerary teeth in the mandibular anterior region
  • No history of blood-borne infectious diseases
  • No systemic diseases or medical conditions

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique

Procedure

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Official study title

Gingival Phenotype Thickening Using Injectable PRF Alone or Combined With a Semi-Surgical Approach: A Split-Mouth Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 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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