Biofiller and Gingival Phenotype Thickening

The periodontal phenotype is determined by gingival thickness (GT), the width of keratinized tissue (KTW), and buccal bone thickness. A thin phenotype (GT ≤1 mm) is more susceptible to inflammation, trauma, and surgical complications. To increase soft tissue thickness, autogenous grafts such as connective tissue grafts (CTG) or biomaterials like collagen matrices are used. However, autogenous grafts require a second surgical site, which may reduce patient comfort.

Biofiller is a novel autologous material prepared by heating platelet-poor plasma (PPP) and combining it with concentrated platelet-rich fibrin (c-PRF), resulting in a biocompatible gel with prolonged resorption time and regenerative potential.

This randomized controlled clinical trial aims to compare the effectiveness of Biofiller versus connective tissue graft in increasing gingival thickness in patients with a thin gingival phenotype.

In the literature, several clinical indications have been proposed for phenotype modification in individuals with a thin phenotype, such as prior to orthodontic treatment, when implant placement is planned, or when a restoration is intended to be placed subgingivally. Therefore, all participants in this study will undergo an orthodontic evaluation prior to treatment.

A total of 34 systemically healthy patients with a thin phenotype in the mandibular anterior region will be enrolled. All participants will undergo a standardized tunneling procedure (canine to canine). The test group will receive a single injection of 0.5 mL Biofiller per tooth, while the control group will receive a connective tissue graft.

To ensure standardization, individuals with Class II or Class III orthodontic anomalies will be excluded. Lateral cephalometric radiographs will be obtained to measure buccal bone thickness at three points per tooth, and an average value will be calculated. Only patients with a Class I skeletal relationship and an orthodontic treatment indication will be included.

Clinical parameters including GT, KTW, and digital soft tissue thickness (via intraoral scanner) will be recorded at baseline, and at 1, 3, and 6 months.

Inclusion criteria

• Age between 18 and 60 years
• Systemically healthy individuals
• Presence of 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

Exclusion criteria

• Systemic diseases (e.g., diabetes, hypertension, cancer, etc.)
• Use of medications that may affect healing (e.g., corticosteroids, 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