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Related Concept Videos

Randomized Experiments01:13

Randomized Experiments

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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
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Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Blinding01:11

Blinding

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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Randomized Controlled Trials for Oral Leukoplakia.

Michele Lodolo1, Jack Valor2, Alessandro Villa1,2

  • 1Department of Orofacial Sciences, School of Dentistry, University of California San Francisco, San Francisco, California, USA.

Oral Diseases
|June 3, 2025
PubMed
Summary
This summary is machine-generated.

Emerging treatments for oral leukoplakia, including topical agents and laser therapies, show limited success in preventing long-term recurrence or malignant transformation. Further research is needed for effective oral leukoplakia management.

Keywords:
malignant transformationoral leukoplakiarandomized controlled trialstreatment

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Area of Science:

  • Oral Medicine
  • Oncology
  • Dermatology

Background:

  • Oral leukoplakia presents as white plaques with a significant risk of malignant transformation.
  • Current treatments like excision and laser ablation have limitations, including recurrence and persistent malignant potential.

Purpose of the Study:

  • To review randomized controlled trials (RCTs) published between 2014 and 2024 on emerging treatment strategies for oral leukoplakia.
  • To identify novel therapeutic approaches and assess their efficacy in managing oral leukoplakia and preventing malignant progression.

Main Methods:

  • A systematic review of 7 randomized controlled trials on oral leukoplakia treatments was conducted.
  • Studies evaluated interventions including topical Moringa oleifera, curcumin, beta-carotene with vitamin C, surgical excision, laser ablation, and photodynamic therapy.

Main Results:

  • Some evaluated interventions demonstrated reductions in lesion size and short-term recurrence rates.
  • No treatment strategy reviewed proved effective in preventing long-term recurrence or malignant transformation of oral leukoplakia.
  • The available data from these RCTs are limited.

Conclusions:

  • Current emerging treatments for oral leukoplakia offer limited benefits regarding long-term outcomes.
  • Further large-scale, rigorously designed randomized controlled trials are essential to establish effective management strategies.
  • There is an unmet need for novel therapies to prevent malignant transformation in oral leukoplakia patients.