Biofiller versus connective tissue graft to thicken lower front gums
Official title: Evaluation of the Effectiveness of Blood Concentrate Biofiller in Thickening the Gingival Phenotype Around Natural Teeth
Run by Inonu University · NCT07104019 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Inonu University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Malatya) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | November 3, 2025 |
| Study ends | May 1, 2026 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT07104019 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.