New Periodontitis Treatment Based on Hyaluronic Acid & Melatonin

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03656484
Study type	Interventional
Source	Concordia Dent Srl
Contact
Status	Completed
Phase	Phase 2
Start date	January 15, 2019
Completion date	December 20, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin — HAMELDENT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms