Non-surgical Treatment of Peri-implantitis Using Chitosan Brush and Tetracycline Slurry

Summary

Aim: The aim of this prospective, randomized, parallel arm, blind clinical trial is to compare the clinical and radiographic outcomes following non-surgical treatment of mild peri-implant defects using Labrida Bioclean with or without the application of tetracycline slurry. Research Hypothesis: The hypothesis is that the adjunctive application of tetracycline slurry will enhance the clinical and radiographic results of non-surgical treatment of mild peri-implant defects (defined as peri-implant bone loss 3-6 mm with pocket depths 6 mm or deeper) with Labrida Bioclean. Probing pocket depth (PPD) reduction will be the primary outcome, whereas clinical attachment level (CAL), radiographic bone fill (RBF), recession depth (REC), modified bleeding index (mBI), presence of plaque (PL) , suppuration on probing (SUP) and Matrix Metalloproteinase-8 (MMP-8) levels on peri-implant sulcus fluid (PISF) will constitute the secondary outcome measures. Groups: Active comparator group: Debridement with Labrida Bioclean Experimental group: Debridement with Labrida Bioclean and irrigation with tetracycline slurry At the end of the treatment procedure patients will be given oral hygiene instructions and specifically patients of the experimental group will be instructed to refrain from oral hygiene for 24 hours before initiating oral hygiene. 1 month after therapy patients will be re-evaluated as a mean of PPD, CAL, REC, mBI, PL, SUP measurements and levels of MMP-8 on PISF. 3 months after therapy will be re-evaluated for second time as in the 1 month re-evaluation. Furthermore, treatment will be repeated as it was randomized on baseline. On 6 month re-evaluation PPD, CAL, REC, mBI, PL, SUP measurements will be made and also a periapical x-ray will be taken to compare the peri-implant bone level with the respective bone level on the x-ray of the baseline. On all of these appointments oral hygiene instructions and motivation will be given to the patients.

Timeline

Start

2024-02-05

Primary completion

2025-05-05

Completion

2025-05-05

Publications

• Background Koldsland OC, Scheie AA, Aass AM. Prevalence of peri-implantitis related to severity of the disease with different degrees of bone loss. J Periodontol. 2010 Feb;81(2):231-8. doi: 10.1902/jop.2009.090269.
• Background Costa FO, Takenaka-Martinez S, Cota LO, Ferreira SD, Silva GL, Costa JE. Peri-implant disease in subjects with and without preventive maintenance: a 5-year follow-up. J Clin Periodontol. 2012 Feb;39(2):173-81. doi: 10.1111/j.1600-051X.2011.01819.x. Epub 2011 Nov 23.
• Background Sorsa T, Ding Y, Salo T, Lauhio A, Teronen O, Ingman T, Ohtani H, Andoh N, Takeha S, Konttinen YT. Effects of tetracyclines on neutrophil, gingival, and salivary collagenases. A functional and western-blot assessment with special reference to their cellular sources in periodontal diseases. Ann N Y Acad Sci. 1994 Sep 6;732:112-31. doi: 10.1111/j.1749-6632.1994.tb24729.x.
• Background Mensi M, Scotti E, Calza S, Pilloni A, Grusovin MG, Mongardini C. A new multiple anti-infective non-surgical therapy in the treatment of peri-implantitis: a case series. Minerva Stomatol. 2017 Dec;66(6):255-266. doi: 10.23736/S0026-4970.17.04054-7. Epub 2017 Oct 3.
• Background Mombelli A, Feloutzis A, Bragger U, Lang NP. Treatment of peri-implantitis by local delivery of tetracycline. Clinical, microbiological and radiological results. Clin Oral Implants Res. 2001 Aug;12(4):287-94. doi: 10.1034/j.1600-0501.2001.012004287.x. English, French, German.
• Background Roos-Jansaker AM, Renvert H, Lindahl C, Renvert S. Submerged healing following surgical treatment of peri-implantitis: a case series. J Clin Periodontol. 2007 Aug;34(8):723-7. doi: 10.1111/j.1600-051X.2007.01098.x. Epub 2007 May 29.
• Background Samuelsson RS, Valnes AK, Wohlfahrt JC. Nonsurgical Treatment of Peri-implantitis Using a Chitosan Brush with Adjunctive Chemical Decontaminants- A Retrospective Case Series. Int J Oral Maxillofac Implants. 2022 Nov-Dec;37(6):1261-1267. doi: 10.11607/jomi.9602.
• Background Khan SN, Koldsland OC, Roos-Jansaker AM, Wohlfahrt JC, Verket A, Mdala I, Magnusson A, Salvesen E, Hjortsjo C. Non-surgical treatment of mild to moderate peri-implantitis using an oscillating chitosan brush or a titanium curette-A randomized multicentre controlled clinical trial. Clin Oral Implants Res. 2022 Dec;33(12):1254-1264. doi: 10.1111/clr.14007. Epub 2022 Oct 18.
• Background Wohlfahrt JC, Evensen BJ, Zeza B, Jansson H, Pilloni A, Roos-Jansaker AM, Di Tanna GL, Aass AM, Klepp M, Koldsland OC. A novel non-surgical method for mild peri-implantitis- a multicenter consecutive case series. Int J Implant Dent. 2017 Dec;3(1):38. doi: 10.1186/s40729-017-0098-y. Epub 2017 Aug 3.

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