Biofiller versus connective tissue graft to thicken lower front gums
Evaluation of the Effectiveness of Blood Concentrate Biofiller in Thickening the Gingival Phenotype Around Natural Teeth
This trial will test whether a new autologous gel called Biofiller or the standard connective tissue graft better thickens thin gums in adults with thin lower front teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Inonu University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Malatya) |
| Trial ID | NCT07104019 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial comparing Biofiller (an autologous gel made from heated platelet-poor plasma combined with concentrated platelet-rich fibrin) to the standard connective tissue graft for increasing gingival thickness in the mandibular anterior region. Thirty-four systemically healthy, non-smoking adults with a thin gingival phenotype will be randomized and all will receive a standardized tunneling procedure from canine to canine. Outcomes will focus on changes in gingival thickness and keratinized tissue using clinical and imaging measurements at baseline and follow-up. The study aims to determine whether Biofiller can offer comparable tissue thickening with less donor-site morbidity than autogenous grafting.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults aged 18–60, non-smokers, not pregnant or breastfeeding, with a thin gingival phenotype in the lower front (canine-to-canine) region and no medications or conditions that impair wound healing.
Not a fit: Patients with systemic diseases, smokers, poor oral hygiene, prior radiotherapy/chemotherapy, complex orthodontic anomalies, or a thick gingival phenotype are unlikely to benefit from this specific comparison.
Why it matters
Potential benefit: If successful, Biofiller could provide a less invasive way to thicken thin gums while avoiding a second surgical donor site and improving patient comfort.
How similar studies have performed: Connective tissue grafting is an established method to increase gingival thickness, while platelet-rich fibrin and other autologous platelet-derived materials have shown promising but limited evidence, and Biofiller itself is a novel formulation with limited published data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Malatya
- Inonu university — Malatya, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Kubra Aral, PhD — Inonu University
- Study coordinator: Kubra Aral, PhD
- Email: kubra.aral@inonu.edu.tr
- Phone: 00903410106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.