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

January 23, 2020 updated by: Corina Marilena Cristache, Concordia Dent Srl

Innovative Technology for Assessing the Periodontal Disease and 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 041335
        • Concordia Dent Clinic
      • Bucharest, Romania
        • "Carol Davila"University of Medicine and Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • TM-MHa group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before treatment (Baseline), at 6 months post treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before treatment (Baseline), at 6 months post treatment completion
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.
before treatment (Baseline), at 6 months post treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concordia Dent Srl

Collaborators

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

Investigators

  • Principal Investigator: CORINA MARILENA CRISTACHE, Carol Davila University of Medicine and Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCDI-UEFISCDI 39/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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