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Trial record 24 of 214 for:    TETRACYCLINE

New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin (HAMELDENT)

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ClinicalTrials.gov Identifier: NCT03656484
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : January 17, 2019
Sponsor:
Collaborators:
Carol Davila University of Medicine and Pharmacy
Romanian National Authority for Scientific Research and Innovation (UEFISCIDI)
University Politechnica of Bucharest
TURKEY MEDISEN Ltd
Information provided by (Responsible Party):
Corina Marilena Cristache, Carol Davila University of Medicine and Pharmacy

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Tetracycline-Metronidazole (TM) group Drug: TM-Melatonin-Hyaluronic acid (TM-MHa) group Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Innovative Technology for Assessing the Periodontal Disease and New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Tetracycline-Metronidazole (TM) group
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
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 Name: TM group

Experimental: TM-Melatonin-Hyaluronic acid (TM-MHa) group
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
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 Name: TM-MHa group




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656484


Contacts
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Contact: CORINA MARILENA CRISTACHE, DMD, PhD +4 0723227020 corinacristache@gmail.com
Contact: ANDREEA CRISTIANA DIDILESCU, DMD, PhD +0722536798 andreea.didilescu@gmail.com

Locations
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Romania
Concordia Dent Clinic Recruiting
Bucharest, Romania, 041335
Contact: CORINA MARILENA I CRISTACHE, Investigator    +4 0755227020    CORINACRISTACHE@GMAIL.COM   
Principal Investigator: CORINA MARILENA I CRISTACHE, DMD, PhD         
Sub-Investigator: GHEORGHE CRISTACHE, DMD         
Sub-Investigator: Mihai Burlibasa, DMD, PhD         
"Carol Davila"University of Medicine and Pharmacy Recruiting
Bucharest, Romania
Contact: Corina Marilena I Cristache, DMD, PhD    +4 0723227020    corinacristache@gmail.com   
Sub-Investigator: Mihai Andrei, DMD         
Sub-Investigator: Andreea Didilescu, DMD         
Sponsors and Collaborators
Concordia Dent Srl
Carol Davila University of Medicine and Pharmacy
Romanian National Authority for Scientific Research and Innovation (UEFISCIDI)
University Politechnica of Bucharest
TURKEY MEDISEN Ltd
Investigators
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Principal Investigator: CORINA MARILENA CRISTACHE Carol Davila University of Medicine and Pharmacy

Publications:

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Responsible Party: Corina Marilena Cristache, Senior Lecturer, DMD, PhD, Oral and Maxillofacial Surgeon, Project responsable, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT03656484     History of Changes
Other Study ID Numbers: CCDI-UEFISCDI 39/2018
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corina Marilena Cristache, Carol Davila University of Medicine and Pharmacy:
Melatonin
Hyaluronic Acid
Tetracycline
Metronidazole
topic paste
chronic periodontitis
Additional relevant MeSH terms:
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Tetracycline
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Metronidazole
Melatonin
Hyaluronic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protein Synthesis Inhibitors
Enzyme Inhibitors