Clinical Trials Directory

Trials / Completed

CompletedNCT07395726

Impact of Platelet-Rich Fibrin on Periodontal Tissue Regeneration

Impact of Platelet-Rich Fibrin on Periodontal Tissue Regeneration: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Armed Forces Institute of Dentistry, Pakistan · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

The purpose of this research is to assess the efficacy of Platelet-Rich Fibrin (PRF) in the regeneration of periodontal tissues in patients suffering from periodontal disease. Periodontal disease is a chronic inflammatory disease that affects the gums and the bone supporting the teeth, which can eventually result in the loss of teeth if left untreated. Conventional periodontal treatment can control the infection and halt the progression of the disease but cannot reverse the loss of the supporting structures. Platelet-Rich Fibrin is a biologic material derived from a small amount of the patient's own blood. It has growth factors that can potentially enhance healing and facilitate the regeneration of bone and soft tissues. In this randomized controlled clinical trial, patients will be randomly assigned to either conventional periodontal surgical treatment or conventional treatment along with PRF. Over a predetermined follow-up period, clinical measurements like gum pocket depth, attachment levels, and radiographic bone changes will be assessed to see if PRF offers any extra advantages in tissue healing and regeneration. The results of this study could improve long-term oral health outcomes and periodontal disease treatment approaches.

Detailed description

Periodontal disease is marked by the inflammation-mediated loss of the supporting structures of the teeth, leading to the formation of periodontal pockets, loss of clinical attachment, and resorption of the alveolar bone. The regenerative aspect of periodontal therapy aims at the replacement of these lost structures to improve the stability of the teeth and their functional status in the oral environment. Platelet-Rich Fibrin (PRF), an autologous platelet concentrate derived from the centrifugation of the patient's blood, is a fibrin matrix rich in growth factors that could potentially improve wound healing, angiogenesis, and bone regeneration. The aim of this randomized controlled clinical trial is to assess the additional role of PRF when used in combination with conventional periodontal surgical therapy compared to conventional therapy alone in patients diagnosed with periodontal defects that require surgical treatment. The participants will be randomly assigned into two groups. The control group will undergo conventional periodontal surgical therapy, while the intervention group will undergo the same surgical therapy plus PRF. The procedures will be carried out according to standardized clinical protocols to ensure uniformity among the participants. The clinical outcomes will be measured by changes in pocket depth, clinical attachment level, and other periodontal parameters. Radiographic analysis will also be conducted to evaluate bone fill and regenerative outcomes at specific intervals. The safety of the procedure will be continuously monitored, and since the PRF is autologous, the risk of immunologic reaction is minimal. This study will offer high-quality evidence on the effectiveness of PRF as a regenerative tool in periodontal therapy and may help in making better clinical decisions in the treatment of periodontal defects.

Conditions

Interventions

TypeNameDescription
PROCEDUREOpen Flap DebridementParticipants assigned to this arm will undergo conventional open flap debridement (OFD) for the treatment of periodontal intrabony defects. The procedure involves flap elevation, thorough debridement of granulation tissue, root surface instrumentation, defect decontamination, and flap repositioning with suturing. Standard postoperative care and oral hygiene instructions will be provided.
PROCEDUREPlatelet-Rich Fibrin with Open Flap DebridementParticipants assigned to this arm will receive autologous Platelet-Rich Fibrin (PRF) as an adjunct to conventional open flap debridement. PRF will be prepared from the participant's venous blood using centrifugation and placed directly into the periodontal defect prior to flap closure to promote tissue regeneration and enhance healing. All other surgical and postoperative procedures will be identical to the control group.

Timeline

Start date
2025-05-20
Primary completion
2025-10-25
Completion
2025-11-15
First posted
2026-02-09
Last updated
2026-02-09

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT07395726. Inclusion in this directory is not an endorsement.