New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin

Chronic Periodontitis Clinical Trial

— HAMELDENT  

Official title:

Innovative Technology for Assessing the Periodontal Disease and New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656484
• Other study ID #: CCDI-UEFISCDI 39/2018
• Status: Completed
• Phase: Phase 2
• Start date: January 15, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2020
• Source: Concordia Dent Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Local drug delivery agents in periodontology has gained acceptance and popularity compared to systemic drugs due to decreased risk in development of resistant flora, opportunist infection, and side effects.

In order to improve the topical treatment for chronic periodontitis, Melatonin and Hyaluronic Acid have been added to antimicrobial topic paste commercially available.

• A complex matrix composed of Tetracycline, Metronidazole, Melatonin and Hyaluronic Acid have been developed for local treatment of chronic periodontitis.

• Microbiological, physical, chemical characterization of the newly obtained matrix and biocompatibility tests have been performed.

• A randomized clinical trial will be perform on 50 patients with moderate chronic periodontitis recruited based on eligibility criteria and informed consent signed.

• Mechanical debridement of the pockets by scaling and root planning will be performed prior to the adjunctive therapy.

• Extensive clinical examination including charting the remaining teeth, clinical attachment level (CAL), presence of dental plaque (PI), gingival index (GI), calculus (CI), bleeding on probing (BOP), radiographic assessment and identification of periodontal pathogens with micro-IDent® test will be performed at the beginning of the study and 6 month after its completion.

• Each patient will be randomized using sealed envelopes (according to a computer-generated randomization list) to one of the following topical administration (in the periodontal pocket of affected teeth), for 30 consecutive days: Tetracycline and Metronidazole paste (TM), n=25 patients and Tetracycline, Metronidazole, Melatonin, Hyaluronic Acid paste (TM-MHa), n=25 patients.

• A statistical evaluation of data recorded during the entire follow-up period will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• moderate chronic periodontitis, that is, > 2 interproximal sites with AL > 4 mm (not on the same tooth), or > 2 interproximal sites with pocket depth (PD) > 5 mm (not on the same tooth) (1),

• at least 20 teeth present in the mouth,

• no periodontal therapy during the last 6 months,

• no antibiotic during the last 6 months,

• good general health (no systemic condition affecting the course of periodontal disease, including malignancy), pregnancy,

• no allergy to the product components,

• good mental health.

Exclusion Criteria:

• Patients not willing to sign consent form.

• Patients not agreeing with the treatment protocol.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Tetracycline-Metronidazole (TM) group
Following mechanical debridement (scaling and root planning) the above-mentioned paste will be topically administrated in the periodontal pocket of affected teeth once a day, for 30 consecutive days.
• TM-Melatonin-Hyaluronic acid (TM-MHa) group
Following mechanical debridement (scaling and root planning) the above-mentioned paste will be topically administrated in the periodontal pocket of affected teeth once a day, for 30 consecutive days.

Locations

Country	Name	City	State
Romania	"Carol Davila"University of Medicine and Pharmacy	Bucharest
Romania	Concordia Dent Clinic	Bucharest

Sponsors (5)

Lead Sponsor	Collaborator
Concordia Dent Srl	Carol Davila University of Medicine and Pharmacy, Romanian National Authority for Scientific Research and Innovation (UEFISCIDI), TURKEY MEDISEN Ltd, University Politechnica of Bucharest

Country where clinical trial is conducted

Romania, 

References & Publications (10)

Andersen LP, Gögenur 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Matesanz-Pérez P, García-Gargallo M, Figuero E, Bascones-Martínez 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. Review. — View Citation

Montero J, López-Valverde N, Ferrera MJ, López-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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Clinical attachment level (CAL)	Changes CAL from Baseline (before treatment) at 6 months will be assessed using a standardised protocol.	before treatment (Baseline), at 6 months post treatment completion
Secondary	Changes in Alveolar bone height	Changes in the alveolar bone height from Baseline (before treatment) at 6 months will be assessed using standardised Radiographic measurements.	before treatment (Baseline), at 6 months post treatment completion
Secondary	Treatment's influence on bactrial pathogens	Periodontal pathogens will be identified by performing micro-IDent® assay before treatment (Baseline) and 6 month after its completion. Micro-IDent® test uses chain polymerisation reaction, with colorimetric detection, to identify the following pathogens: Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Bacteroides forsythus, Treponema denticola.	before treatment (Baseline), at 6 months post treatment completion