Improving gum tissue around dental implants using PRF and collagen matrix A randomized clinical study

Peri-implant mucosal enhancement using leukocyte-platelet rich fibrin combined with a volume-stable collagen matrix versus a volume-stable collagen matrix alone: A randomized controlled trial - PRF-IMPACT Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/113064

Enrollment

Registered

2026-06-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K06- Other disorders of gingiva and edentulous alveolar ridge

Interventions

Intervention1: PRF: leukocyte-platelet rich fibrin (L-PRF) combined with a volume-stable collagen matrix total duration 20 months Control Intervention1: volume stable collagen matrix alone: This stud

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects aged 20 to40 years, of either sex. 2.Patients with a chief complaint of esthetic concern in the anterior maxillary region. 3.Partially edentulism in the anterior esthetic zone indicated for dental implant placement. 4.Presence of a thin to moderate gingival phenotype, assessed clinically using the probe transparency method. 5.Adequate residual alveolar bone volume at the implant site, defined as Minimum bone width less than equal to 6 mm Sufficient bone height to allow implant placement without simultaneous bone grafting. 6.Systemically healthy individuals (ASA I). 7.Sites not requiring simultaneous guided bone regeneration (GBR) or bone augmentation procedures. 8.Patients with good oral hygiene status and willingness to comply with study visits and instructions. 9.Patients who are able to understand the study protocol and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients suffering from any systemic diseases / systemic conditions 2.Smokers or tobacco users 3.Pregnant or lactating women 4.Uncontrolled systemic diseases 5.Active periodontal disease 6.Sites requiring bone grafting 7.Previous soft tissue augmentation at the implant site 8.Patients who, for various reasons (e.g. allergy to porcine collagen, religious or life ethics -vegetarian or vegan - personal choices), refused to receive a graft of animal origin.

Design outcomes

Primary

Measure	Time frame
Sites treated with L-PRF in combination with a volume-stable collagen matrix demonstrate a statistically significant improvement in peri-implant mucosal thickness, early wound healing, postoperative pain, patient-reported discomfort, and esthetic outcomes compared to sites treated with a volume-stable collagen matrix alone at the time of implant placement.Timepoint: baselin, 1 month, 3 months, 6 months	—

Measure

Time frame

Sites treated with L-PRF in combination with a volume-stable collagen matrix demonstrate a statistically significant improvement in peri-implant mucosal thickness, early wound healing, postoperative pain, patient-reported discomfort, and esthetic outcomes compared to sites treated with a volume-stable collagen matrix alone at the time of implant placement.Timepoint: baselin, 1 month, 3 months, 6 months

—

Secondary

Measure	Time frame
a statistically significant improvement in peri-implant mucosal thickness, early wound healing, postoperative pain, patient-reported discomfort, & esthetic outcomes compared to sites treated with a volume-stable collagen matrix alone at the time of implant placement.Timepoint: baselin, 1 month, 3 months, 6 months	—

Countries

India

Contacts

Public ContactDeepika Thakur

Sri Siddhartha Dental College

ssdctumkur@gmail.com9828268896

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026