Urgent need for RCTs in peri-implantitis treatment
A systematic review on the therapy of peri-implantitis was recently undertaken by the department of periodontology at the School of Dentistry, University of Athens in Greece. Dental Learning Hub spoke with the research team, Drs Sortirios Kotsovilis, Ioannis Karoussis, Maria Trianti and Iaonnis Fourmoussis about the outcomes and what the study indicates for the field.
Dental Learning Hub: Briefly explain the background to this systematic review.
Authors: Nowadays, a continually increasing number of implants is placed in everyday clinical practice. By analogy, an increasing prevalence of peri-implantitis may be anticipated, emphasizing the need for predictable methods of therapy of this pathological entity. As highlighted by conventional (Roos-Jansåker et al. 2003, Heitz-Mayfield & Lang 2004, Schou et al. 2004) and systematic (Klinge et al. 2002, Romeo et al. 2004) reviews, no randomized controlled clinical trials (RCTs) had been conducted up to and including 2004 on the efficacy of therapeutic modalities for peri-implantitis.
Proposed protocols, such as Cumulative Interceptive Supportive Therapy (CIST) in the University of Berne, actually have never been documented based on scientific evidence. Over the last four years (2005-2008), however, certain randomized controlled and/or comparative clinical trials appeared in the literature and a systematic review evaluating this recent available material had not been published in a peer-reviewed journal.
Accordingly, it seemed essential to publish such a systematic review, aiming at promoting the conduction of a higher number of well designed studies on the therapy of peri-implantitis and generally enhance clinical research on a topic which is highly important in everyday clinical practice and engages a continuously increasing interest.
On the basis of these considerations, the aim of this study (Kotsovilis et al. 2008) was to perform a systematic review of randomized controlled and/or comparative clinical trials published in the international peer-reviewed literature in the English language, up to and including July 2007, regarding the efficacy of all treatment modalities implemented for the therapy of peri-implantitis.
Dental Learning Hub: What were the most significant outcomes of your review?
Authors: The general outcomes reveal that available randomized controlled and/or comparative clinical trials are limited in number and have short follow-up periods and small sample sizes, thereby exhibiting a high risk of bias. It is still dubious which therapeutic strategies are the most efficacious for the treatment of peri-implantitis lesions, according to their morphology, extent and severity. However, this conclusion in no way suggests that currently implemented treatment modalities may not provide beneficial outcomes in clinical practice.
Specific outcomes show that to date, mechanical debridement combined with antiseptic/antibiotic therapy, Er:YAG laser or regenerative techniques may be successfully implemented for treating various cases of peri-implantitis, but the indications of each technique have not been accurately demarcated.
Dental Learning Hub: In your conclusion you highlight the need for ‘more well-designed, preferably longitudinal, randomized controlled clinical trials’. Why do you think there is not a substantial amount of these being conducted at the moment, bearing in mind implants have been in dentistry for decades and that RCTs abound when it comes to testing other aspects of implants, such as early loading etc?
Authors: This is an interesting question and we hope that clinical research on therapy of peri-implantitis will gradually improve in the future. A reason that could possibly account for the limited amount of RCTs might be ethical considerations. During the early years of implant therapy, there was probably a difficulty in selecting an appropriate control group for an RCT.
For ethical reasons, no patients could be left untreated, but on the other hand it was not appropriately scientifically documented which therapy ought to be regarded as the gold standard, serving as the control procedure. As revealed by our systematic review (Kotsovilis et al. 2008), recent RCTs have mostly used submucosal mechanical debridement as the control procedure. Since this treatment modality is now beginning to be recognized as a sufficiently documented control procedure, a gradually increasing number of RCTs in the future may compare various therapeutic methods with submucosal mechanical debridement.
If such RCTs adequately document the efficacy of other treatment modalities, then these modalities could serve, in turn, as control procedures for other comparisons and by this methodology our knowledge will progressively increase. This progress is not likely to be carried out by separate researchers, but rather a coordinated effort in many countries has to be made. It appears that such a coordinated effort has not been made up until now, which is possibly another reason for the currently limited knowledge.
Another factor hampering the progress of research on the subject is that many therapeutic techniques clearly have different indications and therefore should not be compared to each other. For example, if an RCT aims at evaluating the efficacy of guided bone regeneration or resective surgical techniques for the therapy of deep peri-implantitis lesions, then submucosal mechanical debridement should not be selected as the control procedure, because it is ethically not acceptable to implement a clearly insufficient therapeutic method, which actually has different indications from those of regenerative or resective surgical procedures. This issue is also covered in the answer to the subsequent question.
Dental Learning Hub: How do you suggest the techniques such as mechanical debridement combined with antiseptic/antibiotic therapy, the Er:YAG laser or regenerative techniques should be delineated clearly?
Authors: A number of RCTs have to be conducted on the efficacy of each of these techniques in the therapy of various peri-implantitis lesions, strictly defined according to their characteristics (depth, width, morphology, extent etc.); the characteristics of study participants also have to be clearly defined. Following the publication of such RCTs, the cases in which each technique is more efficacious and therefore indicated will gradually become documented.
Dental Learning Hub: What scope is there for additional therapeutic methods such as ozone to be introduced to the evidence base on this particular subject?
Authors: Most recently, a systematic review (Azarpazhooh & Limeback 2008) evaluated the evidence available for all clinical applications of ozone in dentistry. The authors concluded that currently there is insufficient evidence for the clinical application of ozone in implantology. Concerning its use in the therapy of peri-implantitis, no clinical studies at all have been carried out. However, the aforementioned systematic review pointed out that some in vitro studies have demonstrated the antimicrobial properties of ozone with regard to microorganisms of the oral cavity. Thus, conceptually, ozone could have the potential to be employed as an adjunct in the treatment of peri-implantitis lesions, but of course this hypothesis has to be tested by specially designed RCTs. Until such RCTs are available, no recommendations for clinicians should be made.
Dental Learning Hub: Will you be conducting further research on this area?
Authors: Currently, we are designing a randomized controlled clinical trial on the use of Nd:YAG laser for the therapy of periodontitis. Following the completion of this study, we might expand our research by conducting an analogous randomized controlled clinical trial on the use of Nd:YAG laser for the therapy of peri-implantitis.
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References
Azarpazhooh, A. & Limeback, H. (2008) The application of ozone in dentistry: a systematic review of literature. Journal of Dentistry 36, 104-116.
Heitz-Mayfield, L. J. & Lang, N. P. (2004) Antimicrobial treatment of peri-implant diseases. International Journal of Oral and Maxillofacial Implants 19 (Suppl.), 128-139.
Klinge, B., Gustafsson, A. & Berglundh, T. (2002) A systematic review of the effect of anti-infective therapy in the treatment of peri-implantitis. Journal of Clinical Periodontology 29 (Suppl. 3), 213-225.
Kotsovilis, S., Karoussis, I. K., Trianti, M. & Fourmousis, I. (2008) Therapy of peri-implantitis: a systematic review. Journal of Clinical Periodontology 35, 621-629.
Roos-Jansåker, A.-M., Renvert, S. & Egelberg, J. (2003) Treatment of peri-implant infections: a literature review. Journal of Clinical Periodontology 30, 467-485.
Romeo, E., Ghisolfi, M. & Carmagnola D. (2004) Peri-implant diseases. A systematic review of the literature. Minerva Stomatologica 53, 215-230.
Schou, S., Berglundh, T. & Lang, N. P. (2004) Surgical treatment of peri-implantitis. International Journal of Oral and Maxillofacial Implants 19 (Suppl.), 140-149.
Full article
Therapy of peri-implantitis: a systematic review
Journal of Clinical Periodontology 2008; 35: 621-629.
Authors : Sotirios Kotsovilis, Ioannis K. Karoussis, Maria Trianti, Ioannis Fourmousis
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