New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): Tetracycline-Metronidazole (TM) group; TM-Melatonin-Hyaluronic acid (TM-MHa) group
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): TM group; TM-MHa group
Intervention MeSH terms: Metronidazole; Tetracycline; Melatonin; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Melatonin; Hyaluronic Acid; Tetracycline; Metronidazole; topic paste; chronic periodontitis