Gingival Recessions Treated by CAF with or Without PRF

NCT06591156 | Completed DMC

• 1 other identifier: UCP 2020-123
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gingival recession; Platelet-Rich Fibrin; Root coverage; Periodontal plastic surgery

Outcome Measures

Primary Outcomes (2)

• PERCENTAGE (%) OF ROOT COVERAGE (PRC)

  The primary outcome of this trial was the percentage of root coverage achieved at six months post-surgery. This outcome was chosen due to its high clinical relevance and direct impact on patient care. Clinically, the percentage of root coverage is a crucial measure of success in periodontal surgical procedures aimed at treating gingival recession. It indicates how effectively the exposed root surface has been covered by gingival tissue. The objective is to evaluate whether L-PRF, combined with the coronal advancement flap for root coverage in Miller Class 1 recessions in upper front teeth, will show any significant clinical difference in the root coverage percentage compared to the coronal advancement flap alone. We used two methods to measure the percentual of root coverage: one based on the changes in recession depth (standard), and one based on the changes in recession area for comparison. This metric represents the exact p

  6 months

• COMPLETE AND MEAN ROOT COVERAGE

  % of complete root coverage (%CRC) Complete root coverage indicates that the gingival margin has been successfully repositioned to cover the previously exposed root surface, which is often the primary goal of these treatments. Provides a clear binary outcome (complete vs. incomplete), making it easy to interpret. This measurement is directly correlated with patient satisfaction. Patients typically seek treatment for gingival recession to address aesthetic and sensitivity issues. Patients may only be satisfied when they achieve total coverage of the root surface. Mean Root coverage (MRC) This metric represents the average root coverage achieved in a sample or study group, expressed in absolute terms (e.g., millimeters). It is an absolute measurement that provides information about the amount of root coverage achieved, which can be clinically important.

  6 months

Secondary Outcomes (4)

• KERATINIZED TISSUE WIDTH GAIN

  6 months

• THICKNESS GAIN

  6 months

• PAIN AND HEALING ASSESSMENT

  6 months

• SUBJECTIVE EVALUATION OF RESULTS BY THE PATIENT

  6 months

Study Arms (2)

Procedure with PRF membranes

EXPERIMENTAL

Root coverage procedure. One group received PRF membranes.

Procedure: Root coverage

Control group

ACTIVE COMPARATOR

Coronally advanced flap only without any graft or biomaterial

Procedure: control group

Interventions

Root coverage PROCEDURE

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.

Also known as: Gingival recession

Procedure with PRF membranes

control group PROCEDURE

Coronally advanced flap without any graft or biomaterial

Also known as: Control

Control 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:

• People over 18 years of age
• Nonsmokers or smokers with less than ten cigarettes (self-reported)
• No medical pathology that prevents the application of treatments affects the response of these and the healing process: protein and vitamin deficiency, therapeutic radiation, metabolic disorders (diabetes, hypercalcemia, and others.), drug disorders (antimetabolic, immunosuppressive) and hormonal, allergy to some component of the treatments applied in the study.
• Not be pregnant.
• The presence of oral health with the plaque control record (PCR) and bleeding on probing (BOP)is less than 25%
• At least, the presence of two or more neighboring, or not, gingival recessions Miller class 1 in the anterior upper jaw (central and lateral incisors, canine, first and second premolars.

You may not qualify if:

• not accepted participation in the study
• not signed the informed consent
• recession greater than Miller\'s class1 or RT-1
• presence of any non-controlled disease. 4) Gingival recessions present a minimal amount (\>1,5 mm) of keratinized tissue (KT) apical to the recession area.
• \) Pocket depth (PD) \</=3 mm and CAL interproximal \</ = 0 6) Absence of carious lesions, occlusal trauma, or previous root cover procedures.
• \) Absence of a prosthetic crown on experimental teeth.

Sponsors & Collaborators

• Universidade Salgado de Oliveira: lead
• University of Salamanca: collaborator
• A.T. Still University of Health Sciences: collaborator

Study Sites (1)

Universidade Católica Portuguesa

Viseu, Viseu District, 3504-505, Portugal

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gustavo VO Fernandes, PhD

  A.T. Still University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: May 1, 2020
• Primary Completion: March 10, 2024
• Study Completion: September 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

PT (1)