Gingival Recessions Treated by CAF with or Without PRF

NCT06591156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-09-19

No results posted yet for this study

Summary

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.

Conditions

  • Gingival Recession, Plastic Surgery
  • Platelet

Interventions

PROCEDURE

Root coverage

Treatment of gingival recession, Miller\'s Class I or Cairo\'s RT1, which is the most predictable group to receive interventions without any impairment or problem for the patients. After local anesthesia, a horizontal incision was made, delimitating the coronal part of the flap. This horizontal incision of the envelope flap consists of an oblique submarginal incision in the interdental areas that creates a surgical papilla. The incisions continue with the intrasulcular incision in the recession defects and are extended to form an envelope flap between the central and molar. This design facilitates the planned coronal repositioning of the flap tissue on the exposed root surfaces. The apical gingival tissue at root exposures is raised to a full thickness to provide the critical part of the flap for root coverage with more thickness. Finally, the most apical portion of the flap is elevated in a split-thickness to facilitate coronal displacement of the flap.

PROCEDURE

control group

Coronally advanced flap without any graft or biomaterial

Sponsors & Collaborators

  • University of Salamanca

    collaborator OTHER
  • A.T. Still University of Health Sciences

    collaborator OTHER
  • Universidade Salgado de Oliveira

    lead OTHER

Principal Investigators

  • Gustavo VO Fernandes, PhD · A.T. Still University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2024-03-10
Completion
2024-09-01

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06591156 on ClinicalTrials.gov