CompletedNot Applicable

Gingival Recessions Treated by CAF with or Without PRF

Portugal19 participantsStarted 2020-05-01

Plain-language 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\&#39;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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * 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. Exclusion criteria: * 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 (\&gt;1,5 mm) of keratinized tissue (KT) apical to the recession area. 5\) Pocket depth (PD) \&lt;/=3 mm and CAL interproximal \&lt;/ = 0 6) Absence of carious lesions, occlusal trauma, or previous root cover procedures. 7\) Absence of a prosthetic crown on experimental teeth.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PERCENTAGE (%) OF ROOT COVERAGE (PRC)

Timeframe: 6 months

COMPLETE AND MEAN ROOT COVERAGE

Timeframe: 6 months

Trial details

NCT IDNCT06591156

SponsorUniversidade Salgado de Oliveira

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-10

View on ClinicalTrials.gov More Gingival Recession, Plastic Surgery trials