New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin

NCT03656484 | Completed Phase 2 DMC

• 1 other identifier: CCDI-UEFISCDI 39/2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Periodontitis

Keywords

Melatonin; Hyaluronic Acid; Tetracycline; Metronidazole; topic paste; chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in Alveolar bone height

  before treatment (Baseline), at 6 months post treatment completion

• Treatment's influence on bactrial pathogens

  before treatment (Baseline), at 6 months post treatment completion

Study Arms (2)

Tetracycline-Metronidazole (TM) group

ACTIVE COMPARATOR

Topical administration (in the periodontal pocket of affected teeth), for 30 consecutive days of 3%Tetracycline and 3%Metronidazole paste (TM), n=25 patients, considered control group.

Drug: Tetracycline-Metronidazole (TM) group

TM-Melatonin-Hyaluronic acid (TM-MHa) group

EXPERIMENTAL

Topical administration (in the periodontal pocket of affected teeth), for 30 consecutive days of 3% Tetracycline, 3% Metronidazole, 0.18% Melatonin and 3% Hyaluronic Acid (TM-MHa) paste, n=25 patients, considered experimental group.

Drug: TM-Melatonin-Hyaluronic acid (TM-MHa) group

Interventions

Tetracycline-Metronidazole (TM) group DRUG

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.

Also known as: TM group

Tetracycline-Metronidazole (TM) group

TM-Melatonin-Hyaluronic acid (TM-MHa) group DRUG

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.

Also known as: TM-MHa group

TM-Melatonin-Hyaluronic acid (TM-MHa) group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients not willing to sign consent form.
• Patients not agreeing with the treatment protocol.

Sponsors & Collaborators

• Concordia Dent Srl: lead
• Carol Davila University of Medicine and Pharmacy: collaborator
• Romanian National Authority for Scientific Research and Innovation (UEFISCIDI): collaborator
• University Politechnica of Bucharest: collaborator
• TURKEY MEDISEN Ltd: collaborator

Study Sites (2)

Concordia Dent Clinic

Bucharest, 041335, Romania

Location

"Carol Davila"University of Medicine and Pharmacy

Bucharest, Romania

Location

Related Publications (10)

• 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.

  PMID: 22420873 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.

  PMID: 25494600 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.

  PMID: 23320860 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.

  PMID: 27045432 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.

  PMID: 12096835 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.

  PMID: 29075409 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.

  PMID: 26692007 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.

  PMID: 29438204 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.

  PMID: 10328647 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.

  PMID: 17325947 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• CORINA MARILENA CRISTACHE

  Carol Davila University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, DMD, PhD, Oral and Maxillofacial Surgeon, Project responsable

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 4, 2018
• Study Start: January 15, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2)