 Which is better coffee or hot chocolate? To stay alert coffee is tops. For counting sheep, hot chocolate does the trick. How you answer the question depends on a myriad of factors.
The debate about endodontic therapy versus implants presents a far more complex conundrum. The two approaches have fundamental differences that make a standard evaluation of treatment outcomes extremely challenging.
In science, a level playing field is essential to obtain valid results. So, how do you objectively compare such radically different treatment approaches? Dr. Jianing (Jenny) He, assistant professor in endodontics at Baylor College of Dentistry, along with an interdisciplinary research team, set out to find a common denominator. Their research, which was recently funded by the AAE Foundation, poses a unique solution.
A number of current studies evaluate the outcomes of both procedures. The success rates from these investigations are fairly similar, with root canal therapy having a slight edge. However, the projects vary so substantially in design, evaluation criteria and patient populations that it is virtually impossible to draw objective conclusions.
Objective
The team’s goal was to design a study that would provide data to aid clinicians in making evidence-based decisions for their patients. Other researchers have focused solely on clinical success or failure indicated by the presence of symptoms or radiographic appearance. Dr. He’s team added a new dimension to the criteria.
Patients judge the success of their dental treatment based on how it impacts their quality of life. They expect the outcome to be a tooth that is pain free and functions effectively, results that are aesthetically pleasing and a stress free experience. Since satisfaction in these areas can also be measured and compared, the team decided that quality of life should be investigated as an important factor in determining which treatment is most appropriate. Their primary hypothesis is that endodontic treatment allows a better functional recovery.
Study
Dr. He submitted her proposal to the AAE Foundation in response to a request for proposal that was circulated in July 2007. In October, after making some refinements to the study design, she received a grant of $82,303 for year one of what is anticipated to be a five-year project.
The study began in January 2008 and will run through 2012. Two-hundred patients will participate. Half will receive an implant and half will be treated endodontically. Only patients with a mandibular first molar with failed nonsurgical root canal treatment will be eligible. Patients who have not already received a root canal will be excluded because the decision to save the tooth would be more likely for them. Other factors that might compromise results, such as immune disorders, smoking and certain medications are also exclusion criteria.
Each patient in the study will receive an optimal treatment plan based on their clinical condition. Root canal therapy will be completed in two visits. The treatment will be performed by a second-year resident and supervised by the principal investigator. Clinical and radiographic findings will be evaluated at 6, 12 and 24 months. Implant patients will be treated by an oral surgeon. They will be recalled at 1 week and 1, 3, 6, 12, 18 and 24 months for a similar evaluation. Clinicians will follow a standardized treatment protocol for the patients in both groups.
For the first time ever in a comparative study, the two groups of patients will have their masticatory function evaluated and will complete three questionnaires to assess multiple quality of life issues ranging from ability to chew, taste and enunciate clearly, to perceptions about personal appearance, self-confidence and satisfaction with the treatment process and the cost of the procedure.
A team approach is critical to launching this complex clinical study. An oral surgeon was recruited to evaluate and place all the implants. A prosthodontist will restore the teeth and an orthodontist will evaluate chewing function. In addition, Dr. Milton Packer, a cardiologist and chair of clinical science at University of Texas Southwestern, will consult on managing the clinical aspects of the project. Dr. Packer’s participation is the result of the dental school’s collaboration with University of Texas Southwestern on a $34 million grant from the National Institute of Health. The purpose of the NIH grant is to promote translational research and to train new clinical researchers.
“This grant means so much to me and to my department,” said Dr. He. “Moving from basic science research to clinical research is a big transition and a tremendous opportunity to learn.” Dr. He has been on a research strong track ever since she graduated from dental school at West China University of Medical Sciences in 1997. She earned her certificate in endodontics and a Ph.D. from the University of Connecticut Health Center in 2003. To further hone her skills, she will be enrolling in a course on clinical research management and leadership. “This one project will not provide all the information that we need,” says He. “But, what we learn from this study will give us the data we need to compete for a federal grant that would provide the funding to significantly increase our sample size.”
Concurrent with Dr. He’s proposal, the Foundation also awarded $292,214 to Dr. Walter Bowles, associate professor at the University of Minnesota. Dr. Bowles’ project is a retrospective comparison of initial nonsurgical root canal treatment and retreatment with single-tooth implant supported restorations. The research team will examine case records from 10,000 patients who received treatment to provide a timeline for outcomes over a 10-year period. This project will require two-and-half years to complete. Dr. Bowles’ grant is for project year one.
“In adding to the evidence basis of our specialty, these projects will serve as a spring board for larger and more complex investigations,” says Foundation President Denis E. Simon III. “One of the Foundation’s primary goals is to strengthen endodontic departments. We hope that by providing major grants to both these schools, we have helped them to elevate the specialty’s profile within their respective institutions and to enhance their own fundraising efforts.”
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