NCT06591156: GR with PRF

Gingival Recessions Treated by CAF with or Without PRF

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing Root coverage in Gingival Recession, Plastic Surgery in 19 participants. Completed in 1 September 2024.

Timeline

1 May 2020

Primary endpoint
10 March 2024

1 September 2024

Quick facts

Lead sponsor	Universidade Salgado de Oliveira
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	19
Start date	1 May 2020
Primary completion	10 March 2024
Estimated completion	1 September 2024
Sites	1 location across Portugal

Drugs / interventions tested

• Root coverage
• control group — full drug profile →

Conditions studied

• Gingival Recession, Plastic Surgery — all drugs for Gingival Recession, Plastic Surgery →
• Platelet — all drugs for Platelet →

Sponsor

Universidade Salgado de Oliveira

Who can join

Adults 18 to 65, any sex, with Gingival Recession, Plastic Surgery or Platelet. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study was to compare the efficacy of Coronal Advanced Flap (CAF) alone versus CAF combined with Leukocyte-Platelet-Rich Fibrin (L-PRF) to achieve root coverage in patients with gingival recession. This was assessed by measuring the percentage of root coverage at six months post-surgery. By focusing on the root coverage level, the study aimed to determine whether adding L-PRF to CAF significantly improved over using CAF alone.

The other objective was to provide a comprehensive assessment of the outcomes related to root coverage and overall patient satisfaction. Moreover, different outcomes of recession coverage were assessed, including the percentage of complete root coverage and mean root coverage. These evaluations were intended to offer a more detailed understanding of the possible success of each surgical technique. Additionally, the difference in gingival tissue thickness between the two groups was attempted to measure at six months post-surgery to determine whether the addition of L-PRF to CAF improved tissue quality and stability.

The study also aimed to determine the overall volume gain in gingival tissue in the specific area of recession covered by both techniques, providing information on their regenerative capabilities and the three-dimensional changes in tissue structure.

Furthermore, it sought to analyze the healing and recovery processes by comparing postoperative complications, patient discomfort, and overall recovery time between the two groups. Finally, another goal was to investigate the patient\'s satisfaction with the aesthetic and functional outcomes of the procedures, evaluating their perceptions of the success of treatment and the quality of life after surgery. This comprehensive approach was designed to ensure that all relevant outcomes were considered, offering a robust evaluation of the effectiveness and benefits of combining CAF with L-PRF and providing comparability with previous and future studies.

The positive hypothesis raised was: CAF combined with L-PRF will: (a) result in significantly greater root coverage compared to CAF alone at six months post-surgery; (b) lead to thicker gingival tissue and better tissue quality compared to CAF alone; (c) will have a faster healing and recovery, with fewer complications in the CAF with L-PRF group compared to the CAF alone group; (d) will report higher satisfaction levels with the treatment outcomes compared to those undergoing CAF alone.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment of gingival recession type 1 using coronally advanced flap with leucocytes-platelet rich fibrin: a randomized controlled trial.
   Dos Santos NBM, Fernandes GVO, Marques T, Sousa MC, et al · · 2026 · PMID 42096052 · DOI 10.1007/s00784-026-06899-4