Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07104019

Evaluation of the Effectiveness of Blood Concentrate Biofiller in Thickening the Gingival Phenotype Around Natural Teeth

Led by Inonu University · Updated on 2025-08-12

34

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness of a novel blood concentrate called biofiller with connective tissue grafts in increasing gingival thickness among patients with a thin gingival phenotype. The periodontal phenotype includes gingival thickness and keratinized tissue width, with thin phenotypes being more prone to inflammation and trauma. Platelet-rich concentrates like biofiller have regenerative properties and may provide a less invasive alternative to traditional grafts. Participants will undergo a standardized tunneling surgical procedure in the mandibular anterior region (canine to canine). The test group will receive a single injection of 0.5 mL biofiller per tooth, prepared from the patient's own blood by heating platelet-poor plasma and mixing it with concentrated platelet-rich fibrin. The control group will receive autogenous connective tissue grafts harvested from the palate and placed under the gingiva through the tunnel. Both procedures are done under local anesthesia. Patients will be evaluated at baseline and at 1, 3, and 6 months after treatment. Clinical assessments include measuring gingival thickness, keratinized tissue width, and soft tissue thickness using intraoral scanners. Orthodontic evaluations and lateral cephalometric radiographs will be performed to measure bone thickness and ensure participants have a Class I skeletal relationship. The primary outcome is the change in gingival thickness over time, with safety and comfort monitored throughout the study.

CONDITIONS

Brief Title

Biofiller and Gingival Phenotype Thickening

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Systemically healthy individuals
  • Thin gingival phenotype in the mandibular anterior region (canine to canine)
  • No medications that affect wound healing
  • No history of bleeding disorders
  • No known allergy to anti-inflammatory drugs
  • Not pregnant or breastfeeding
  • Willingness to participate and provide informed consent
  • Non-smoker
Not Eligible

You will not qualify if you...

  • Presence of systemic diseases such as diabetes, hypertension, or cancer
  • Use of medications that may affect healing, including corticosteroids or immunosuppressants
  • History of radiotherapy or chemotherapy
  • Pregnancy or breastfeeding
  • Poor oral hygiene
  • Refusal to participate
  • Age under 18 years
  • Smoking
  • Presence of Class II or Class III orthodontic anomalies

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit

Participants undergo a tunneling procedure in the mandibular anterior region. Depending on their group, they receive either a single injection of Biofiller or a connective tissue graft to increase gingival thickness.

1 visit (in-person)

Follow-up

Duration - 6 months

Participants return for clinical evaluations to measure gingival thickness and other periodontal parameters at 1, 3, and 6 months after treatment.

3 visits (in-person) at 1, 3, and 6 months

Trial Site Locations

Total: 1 location

1

Inonu university

Malatya, Turkey (Türkiye), 44000

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Research Team

K

Kubra Aral, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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