Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants

Summary

The purpose of this prospective clinical study is to evaluate and compare the effectiveness of different cleaning (decontamination) methods for dental implants affected by peri-implantitis. Peri-implantitis is an inflammatory condition caused by a bacterial biofilm on the implant surface, which can lead to bone loss and implant failure if left untreated. Because the rough surface and threads of implants make them difficult to clean, finding the most effective decontamination method is critical for saving the implant. This study will include 90 healthy, non-smoking participants who have a bone-level dental implant affected by peri-implantitis without vertical bone loss. Participants will be randomly assigned to one of three treatment groups (30 implants per group) to undergo a specific decontamination procedure during their surgical treatment: Group 1 (Laser PDT): Decontamination using photodynamic therapy with a blue laser and riboflavin, followed by a sterile saline rinse. Group 2 (GalvoSurge): Decontamination using an electrolytic cleaning device, followed by a sterile saline rinse. Group 3 (Active Control): Decontamination using a 0.2% chlorhexidine gluconate rinse, which is the current standard of care. To measure the effectiveness of these treatments, researchers will take sterile swabs from the implant surface immediately before and after the decontamination process. These swabs will be analyzed using PCR to detect changes in the microbiological load of five specific bacteria known to cause gum and implant disease (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, and Tannerella forsythia). Following the decontamination and swabbing, all participants will receive a standard Guided Bone Regeneration (GBR) procedure using autogenous bone, a xenograft, and a collagen membrane to help rebuild the bone around the implant. By comparing the microbiological results before and after treatment, the study aims to determine whether the newer methods (Laser PDT or electrolytic cleaning) are more effective at removing harmful bacteria than the traditional chlorhexidine rinse prior to bone regeneration.

Timeline

Start

2026-03-01

Primary completion

2027-03-01

Completion

2027-06-01

Publications

• Background Schlee M, Rathe F, Brodbeck U, Ratka C, Weigl P, Zipprich H. Treatment of Peri-implantitis-Electrolytic Cleaning Versus Mechanical and Electrolytic Cleaning-A Randomized Controlled Clinical Trial-Six-Month Results. J Clin Med. 2019 Nov 7;8(11):1909. doi: 10.3390/jcm8111909.
• Background Takasaki AA, Aoki A, Mizutani K, Schwarz F, Sculean A, Wang CY, Koshy G, Romanos G, Ishikawa I, Izumi Y. Application of antimicrobial photodynamic therapy in periodontal and peri-implant diseases. Periodontol 2000. 2009;51:109-40. doi: 10.1111/j.1600-0757.2009.00302.x. No abstract available.
• Background Ntrouka VI, Slot DE, Louropoulou A, Van der Weijden F. The effect of chemotherapeutic agents on contaminated titanium surfaces: a systematic review. Clin Oral Implants Res. 2011 Jul;22(7):681-690. doi: 10.1111/j.1600-0501.2010.02037.x. Epub 2010 Dec 29.
• Background Monje A, Pons R, Insua A, Nart J, Wang HL, Schwarz F. Morphology and severity of peri-implantitis bone defects. Clin Implant Dent Relat Res. 2019 Aug;21(4):635-643. doi: 10.1111/cid.12791. Epub 2019 May 14.
• Background Mombelli A, Decaillet F. The characteristics of biofilms in peri-implant disease. J Clin Periodontol. 2011 Mar;38 Suppl 11:203-13. doi: 10.1111/j.1600-051X.2010.01666.x.
• Background Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

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Indications