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Completed

NCT Number: NCT03656484

New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

"Carol Davila"University of Medicine and Pharmacy, Bucharest, Romania

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: TM-MHa group

Primary outcomes

  1. Changes in Clinical attachment level (CAL)

    Time frame: before treatment (Baseline), at 6 months post treatment completion

    Changes CAL from Baseline (before treatment) at 6 months will be assessed using a standardised protocol.

Secondary outcomes

  1. Changes in Alveolar bone height

    Time frame: before treatment (Baseline), at 6 months post treatment completion

    Changes in the alveolar bone height from Baseline (before treatment) at 6 months will be assessed using standardised Radiographic measurements.

  2. Treatment's influence on bactrial pathogens

    Time frame: before treatment (Baseline), at 6 months post treatment completion

    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.

Sponsors and collaborators

Lead sponsor

Concordia Dent Srl

Other

Collaborators

  • Carol Davila University of Medicine and Pharmacy
  • Romanian National Authority for Scientific Research and Innovation (UEFISCIDI)
  • TURKEY MEDISEN Ltd
  • University Politechnica of Bucharest

Registry information

Official study title

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

Acronym: HAMELDENT

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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