Proposal for Training to Conduct a Clinical Study
On the Effects of Low Level Laser Therapy (LLLT)
And The Treatment of Periodontal Diseases
Dr. Dana Vieru York, DDS, MS, PhDc, Periodontist)
Faculty, Cariology Department, NYU College of Dentistry
The general objective of this training plan is to study methods of collecting, analyzing and presenting data in a form suitable for peer review publication. The trials relevant to inculcate the necessary methods and principles for valid clinical research relate to the application of low-level-laser therapy (LLLT) among diverse populations in the treatment of periodontal disease.
The proposed training will first lay the intellectual groundwork to conceive and design valid studies that would demonstrate whether subjects receiving LLLT in addition to traditional treatment exhibit better recovery and healing than subjects treated without LLLT – e.g. shorter bleeding and pain recovery time, reduced post surgery complications (edema, inflammation, infection,), faster forming and maintaining of the clot, and better maintenance of the masticator functions -- whether the effectiveness of LLLT is a function of the age, and general health and further, whether metabolic a compromise of the patient affecting wound healing, such as diabetes, would be a contra-indication.
We would study the significance of sampling, the proper practices and pitfalls of recruiting patients and the necessity to standardize diagnoses of the advancement of periodontitis and the means by which to do it.
We would study the principles and consequences of grouping, such as (1) diabetic with LLLT, (2) diabetic without LLLT, (3) osteoporosis with LLLT, and (4) osteoporosis without LLLT).
We will train to determine the mean and standard deviations of such factors as:
1. Bleeding time. We will consider gingival bleeding time as the time interval from the end of the curettage until the formation of the blood clot, established by the paper test. The time will be measured with a chronometer. The measurement will be performed in one location.
2. Pain relief time. Pain is a physiological consequence of the surgical trauma, accompanied by inflammation. We will ask the patients to note the evolution of the pain intensity, whether they can use the maxillaries for normal mastication. The time interval described by the patient until the complete resolution of pain will be measured.
3. Bone recovery time. We will determine the bone regeneration by observing the plague healing evolution (reduction of dental mobility, improving of gingival color, recuperation of the masticator function and patient comfort) and by evaluating X-ray images. When clinical parameters indicate bone recovery, we will perform the radiography.
4. The recurrence rate will be monitored and statistically quantified by the numbers.
The objective of the proposed training will be to develop the expertise to determine the parameters of significant factors as well as to account for the foregoing in a scientifically useful manner.
The training would provide competent guidance in the selection of a safe protocol following the data in the LLLT literature, equipping this researcher with the means to evaluate, for example, whether to employ an infrared diode laser type BF (EN 60 601-1), class 3B, safety class 1, with a wave length = 630 nm, whether to employ an intensity of light, for example, from 10 to 30 mW/ cm^2, for about 10 seconds at each application, whether to administer a certain number of applications over time. (Note: the given example of light intensity is comparable to light emitted by a conventional laser pointer and is well below the threshold for injury.)
In a study that would result from the training plan, participating patients would benefit from the classical modern dental treatment of their periodontal disease. We seek to learn how to determine whether patients would further benefit when treated, in addition, with LLLT.
We expect the proposed training to elucidate how the rigorous application of the scientific method alone can lead to responsible advocacy for or against an LLLT modality for treatment of periodontal disease. Optical technology, when sufficiently studied, may support an economical, non-invasive treatment for periodontal infection.
The effects will be studied of collecting clinical data from patient cards from multiple sites.
Statistical evidence measurements and protocols will be conceived and conducted at the Department of Cariology and Comprehensive Care, NYU College of Dentistry.
Training for research will take place at the Department of Cariology and Comprehensive Care, New York University College of Dentistry.
This study will neither require clinical space from school facilities nor time away from teaching.