Biofiller and Gingival Phenotype Thickening

NCT07104019 | Recruiting DMC

• 1 other identifier: 2024-3647
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The periodontal phenotype is defined as the combination of the gingival phenotype and the thickness of the buccal bone plate (bone morphotype). The gingival phenotype refers to the gingival thickness (GT) and the width of the keratinized tissue (KTW). A gingival thickness of ≤1 mm is classified as a thin phenotype, whereas a thickness \>1 mm is considered a thick phenotype. Thin gingival biotypes tend to show more pronounced responses to inflammation, restorations, trauma, and parafunctional habits. Various methods are used to assess gingival thickness, including transgingival probing (TP), ultrasonic measurements, cone-beam computed tomography (CBCT) scans, visual assessment, and colored biotype probes (CBP). Periodontal plastic procedures performed using autogenous grafts such as connective tissue grafts (CTG) and free gingival grafts (FGG), or biomaterials such as acellular dermal matrices (ADM) and collagen matrices (CM), are known to significantly increase GT and the amount of keratinized tissue. However, creating a second surgical site in the oral cavity during these procedures may compromise patient comfort, prompting researchers to explore alternative methods. Additionally, the effectiveness of synthetic biomaterials has been found to be lower than that of autogenous grafts. Platelet-rich concentrates have been used as a minimally invasive procedure for the past thirty years, showing a high capacity to release growth factors that support tissue regeneration. While platelet-rich plasma (PRP), as the first-generation platelet concentrate, is widely used, platelet-rich fibrin (PRF) has been increasingly applied across various fields of medicine and dentistry due to its ability to release more growth factors over a longer period, resulting in better clinical outcomes. PRF is a highly biocompatible material composed of autologous cells and growth factors entrapped in a fibrin matrix, and has been shown to degrade more slowly over time compared to conventional PRP. One of the main reported disadvantages of PRF (and especially PRP) is its relatively rapid resorption, typically within 2-3 weeks. Biofiller is an autologous material derived from the patient's own blood and includes platelet-poor plasma (PPP) and concentrated platelet-rich fibrin (PRF). The PPP component is heated to become enriched with albumin, thereby prolonging its resorption time. The PRF portion contains autologous cells and growth factors. However, conventional PRF is typically resorbed within 2-3 weeks, limiting its clinical application. Recent studies have shown that the resorption time of biofiller-a combination of PPP and PRF-can exceed 4 months. The aim of this study is to compare the effectiveness of biofiller with connective tissue graft in increasing gingival thickness in patients with a thin gingival phenotype. A total of 34 patients (17 patients in each group) will be enrolled. Tunnel surgery will be performed to all participants and test group will receive biofiller only once. Control group will receive connective tissue surgery. Clinical parameters obtained from our patients at baseline and at follow-up visits at 1, 3, and 6 months - including gingival thickness (GT), keratinized tissue width (KTW), and soft tissue measurements assessed via intraoral scanners - will be compared.

Conditions

Gingival Recession; Gingival Diseases; Gingival Inflammation

Keywords

biofiller; gingival phenotype modification; connective tissue graft

Outcome Measures

Primary Outcomes (1)

• Change in Gingival Thickness (GT)

  Gingival thickness will be measured in the mandibular anterior region (canine to canine) using a digital caliper and intraoral scanner. The change in GT from baseline to each follow-up visit will be assessed to evaluate the efficacy of biofiller versus connective tissue graft in augmenting gingival thickness.

  Baseline, 1 month, 3 months, 6 months

Study Arms (2)

Biofiller Injection Group

EXPERIMENTAL

Patients in this group will receive biofiller composed of albumin-enriched platelet-poor plasma (PPP) and concentrated platelet-rich fibrin (c-PRF), prepared from the patient's autologous blood. After a tunneling procedure in the mandibular anterior region (canine-to-canine), 0.5 mL of biofiller will be injected per tooth

Procedure: Biofiller Injection

connective tissue graft group

ACTIVE COMPARATOR

Participants in this group will undergo a minimally invasive tunneling surgical procedure in the mandibular anterior region (canine to canine). Autogenous connective tissue grafts (CTG) will be harvested from the patient's palate and placed under the gingiva through the tunnel to increase gingival thickness. The graft will be stabilized without vertical releasing incisions. No biomaterials or adjunctive agents will be used. All procedures will be performed under local anesthesia by an experienced periodontist.

Procedure: connective tissue graft

Interventions

Biofiller Injection PROCEDURE

Biofiller will be prepared by heating the platelet-poor plasma (PPP) component obtained from peripheral blood, which is then mixed with concentrated PRF (c-PRF). After creating a surgical tunnel in the mandibular anterior region (canine to canine), 0.5 mL of the prepared biofiller will be injected into each tooth region under the gingiva. The procedure is performed under local anesthesia and aims to increase gingival thickness in patients with a thin periodontal phenotype.

Also known as: Albumin-enriched Platelet-Rich Fibrin injection

Biofiller Injection Group

connective tissue graft PROCEDURE

A connective tissue graft will be harvested from the palatal donor site and placed under the gingiva using a minimally invasive tunneling technique in the mandibular anterior region (canine to canine). The procedure will be performed under local anesthesia and aims to increase gingival thickness. No biomaterials or adjunctive agents will be used.

Also known as: Autogenous Connective Tissue Graft

connective tissue graft group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu university

Malatya, 44000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gingival Recession; Gingival Diseases; Gingivitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Infections

Study Officials

• Kubra Aral, PhD

  Inonu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kubra Aral, PhD

CONTACT

00903410106; kubra.aral@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: While the study is open-label for participants and care providers due to the nature of the interventions, clinical measurements and soft tissue scans will be evaluated by a blinded assessor who is unaware of the treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a prospective, randomized, controlled, parallel-arm clinical trial designed to compare the efficacy of biofiller (albumin-enriched PRF) injection and connective tissue grafting in increasing gingival thickness in patients with thin periodontal phenotype.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: July 30, 2025
• Primary Completion: November 3, 2025
• Study Completion: May 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)