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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

The treatment of periodontal diseases; A randomized, doubleblind, four-arm, placebo controlled, 5 year-follow-up clinical intervention trial

Alternative title: null

Awarded: NOK 3.0 mill.

This is a 5 year follow-up, double blind, four arm, placebo controlled clinical intervention trial comparing 4 periodontal treatment strategies. The venue for the study is a local community in Telemark in the southern part of Norway, and includes 184 patients at baseline and 161 patients at the end of the study. The localization makes it possible to study both psycosocial as well as biological and pathological parameters over a period of 7 years. The 5 year results suggest that the most important factor in the treatment strategy is the meticulous and systematic mechanical therapy given by the dentist, and the overall most important factor for a successful therapy is the high standard of oral hygiene that the dentist can impose on the patient. Antibiotics (i.e.Metronidazol) had no clinical effect in the long haul, although the Metronidazole groups were clinically superior to the placebo groups at 1 year. An important microbiological finding was that the therapy could reduce the members of the red complex (P. gingivalis, T. forsythia) to undetectable levels (PCR, Checkerboard, Culture) following therapy and keep it that way in close to 50% of the patients for at least 5 years. These findings contradict previous studies. However, such studies are flawed by insufficient scientific design, few patients, short follow-up and insufficiently described clinical procedures. The most important, and unique feature with the present study is its long follow-up, high number of patients, clinical stringency and general scientific design, which is in accordance with general recommendations. Although the study did not specifically challange the question about periodontal surgery vs. closed scaling and root planing, nearly all study participants were diagnosed with either severe or extencive periodontitis (AAP/CDC/EWP5). Therfore, most of these patienst would have received periodontal surgery as part of the treatment strategy in a general clinical setting, especially by specialists. Periodontal surgery was not part of our study design, and since the clinical results were extremely rewarding even after 5 years, one should at least re-evaluate the use of periodontal surgery in periodontal disease controle. Since the mouthwash Listerine is extremely aggressively marketed in Norway, many of the study participants used this product at screening. In order to give a qualified advice to the participants, and to include or exclude this product in the study, two experiments were set up to answer these questions. The results showed that Listerine, even the new Listerine Professional had no positive effect to the user, and was therefore adviced against to all participants of the study. Since this was a longitudinal study, where radiographs were obtained of all teeth at baseline and 5 years, an obvious problem was described. The angle of the X-ray beam to the receptor would invariably vary, in all locations, from one uptake (baseline) to another (5 years). This would theoretically and variably create a distortion of the tooth/bone image which could produce measurement errors that would superseed the biological/pathological change brought about by the therapy variabel. A plugin for the software program ImageJ was therefore designed and tested. The plugin reduced/eliminated such errors to a minimum, and will be employed in Reading radiographs in this study. The radiographs are being read as this report is published and will be published in JADA in 2017. Smoking and periodontal disease has been an important issue. In this study, we have shown that a variable statistical strategy in different studies results in different conclusions, especially pertaining to the association of smoking on results and recurrence of disease after therapy. Since this study focuses on microbiological - as well as clinical parameters, a methodological study on the checkerboard technique as the microbiological diagnostic tool in longitudinal studies was performed, discussing pitfalls and suggesting improvements for this important technique. Since antibiotic use has been suggested to cause resistance development in oral bacteria a separate study suggests that metronidazole, used as in this project, does not cause resistance development in oral bacteria after 5 years. A «quality of life» study showed that more than 95% of the patients were very satisfied with the treatment (Vatne et al 2015)and showed shortcommings in the communication between patients and their local dentists. Most of the articles from this project has been published, or are accepted for publication. However, we are working on at least 3 articles to be published in 2017. 1) Factors that accompanies success or failure in the therapy of periodontal diseases 2) Radiographic vs. clinical results following 4 different treatment strategies for periodontitis 3) Microbiological results following 4 different treatment strategies for treating periodontitis. -

The project is ongoing. Periodontal disease is a family of bacterial infections characterized by destruction of periodontal supporting tissues. The bacterial flora at the diseased sites is complex, counting > 700 different species in the subgingival denta l plaque. Three main hypotheses exist for the infectious nature of periodontal disease; The non-specific - , specific - and ecological plaque hypothesis as well as the hypothesis of bacterial complexes. The standard treatment of periodontitis is to mecha nically reduce the number of bacteria present by scaling and root planing (SRP), thereby reducing the bacterial challenge in the sites showing disease progression. A high recurrence rate is reported after this kind of treatment. Adding antibiotics to this treatment has not increased the long term success-rate of therapy. A modification of SRP, full mouth disinfection (FDIS), has shown positive results in clinical studies as compared to SRP alone, although the success failed to reproduce in yet other stud ies. However, FDIS is logically potentiating SRP by redusing microbial load beyond what can be acchieved by SRP alone. Thus FDIS may be an additional factor in treating periodontal diseases with SRP and Antibiotics since it reduces the bacterial challange beyond that possible of SRP. It is possible to combine the SRP, antibiotic treatment and FDIS in one, short and resource saving treatment strategy. Thus, the present study is designed to compare the FDIS+Antibiotics, FDIS+Placebo, SRP+antibiotics, and S RP +placebo, and to evaluate clinical treatment results during a 5 year-follow up. If this novel strategy proves to be more-, or as successful as traditional treatment, it may result in a 1) more predictable treatment for patients in general dental cli nics and for patients with specific health challanges. 2) better diagnosis of periodontitis. 3) changes in public spending policy and the guidelines provided by HELFO/NAV. (Political consequence)

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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering