drugset / Trial / NCT03656484
New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin
Phase 2
Completed
50 enrolled
Concordia Dent Srl
Carol Davila University of Medicine and Pharmacy · collabRomanian National Authority for Scientific Research and Innovation (UEFISCIDI) · collabTURKEY MEDISEN Ltd · collabUniversity Politechnica of Bucharest · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim of the present study is to determine whether the association of Melatonin and Hyaluronic Acid to the antimicrobial TM paste (3% Tetracyclin and 3% Metronidazole) for periodontal maintenance therapy can improve the attachment level (AL) and alveolar bone support for moderate chronic periodontitis.
Timeline
- Start
- 2019-01-15
- Primary completion
- 2019-12-20
- Completion
- 2019-12-20
Publications
- Background Eke PI, Page RC, Wei L, Thornton-Evans G, Genco RJ. Update of the case definitions for population-based surveillance of periodontitis. J Periodontol. 2012 Dec;83(12):1449-54. doi: 10.1902/jop.2012.110664. Epub 2012 Mar 16.
- Background Feres M, Figueiredo LC, Soares GM, Faveri M. Systemic antibiotics in the treatment of periodontitis. Periodontol 2000. 2015 Feb;67(1):131-86. doi: 10.1111/prd.12075.
- Background Matesanz-Perez P, Garcia-Gargallo M, Figuero E, Bascones-Martinez A, Sanz M, Herrera D. A systematic review on the effects of local antimicrobials as adjuncts to subgingival debridement, compared with subgingival debridement alone, in the treatment of chronic periodontitis. J Clin Periodontol. 2013 Mar;40(3):227-41. doi: 10.1111/jcpe.12026. Epub 2013 Jan 16.
- Background Jepsen K, Jepsen S. Antibiotics/antimicrobials: systemic and local administration in the therapy of mild to moderately advanced periodontitis. Periodontol 2000. 2016 Jun;71(1):82-112. doi: 10.1111/prd.12121.
- Background Koyama H, Nakade O, Takada Y, Kaku T, Lau KH. Melatonin at pharmacologic doses increases bone mass by suppressing resorption through down-regulation of the RANKL-mediated osteoclast formation and activation. J Bone Miner Res. 2002 Jul;17(7):1219-29. doi: 10.1359/jbmr.2002.17.7.1219.
- Background Montero J, Lopez-Valverde N, Ferrera MJ, Lopez-Valverde A. Changes in crevicular cytokines after application of melatonin in patients with periodontal disease. J Clin Exp Dent. 2017 Sep 1;9(9):e1081-e1087. doi: 10.4317/jced.53934. eCollection 2017 Sep.
- Background Andersen LP, Gogenur I, Rosenberg J, Reiter RJ. The Safety of Melatonin in Humans. Clin Drug Investig. 2016 Mar;36(3):169-75. doi: 10.1007/s40261-015-0368-5.
- Background Diker N, Gulsever S, Koroglu T, Yilmaz Akcay E, Oguz Y. Effects of Hyaluronic Acid and Hydroxyapatite/Beta-tricalcium Phosphate in Combination on Bone Regeneration of a Critical-size Defect in an Experimental Model. J Craniofac Surg. 2018 Jun;29(4):1087-1093. doi: 10.1097/SCS.0000000000004338.
- Background Pirnazar P, Wolinsky L, Nachnani S, Haake S, Pilloni A, Bernard GW. Bacteriostatic effects of hyaluronic acid. J Periodontol. 1999 Apr;70(4):370-4. doi: 10.1902/jop.1999.70.4.370.
- Background Sakai A, Akifusa S, Itano N, Kimata K, Kawamura T, Koseki T, Takehara T, Nishihara T. Potential role of high molecular weight hyaluronan in the anti-Candida activity of human oral epithelial cells. Med Mycol. 2007 Feb;45(1):73-9. doi: 10.1080/13693780601039607.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hyaluronic Acid | Other / unclassified | 3 % | Topical |
| Subject | Melatonin | Small molecule | 0.18 % | Topical |
| Comparator | Metronidazole | Small molecule | 3 % | Topical |
| Comparator | Tetracycline | Unknown | 3 % | Topical |