Clinical trial NCT03656484: New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin
Official title: Innovative Technology for Assessing the Periodontal Disease and New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Keywords: Melatonin
Hyaluronic Acid
Tetracycline
Metronidazole
topic paste
chronic periodontitis
Lead sponsor: Concordia Dent Srl
Sponsor class: OTHER
Collaborators: name: Carol Davila University of Medicine and Pharmacy
name: Romanian National Authority for Scientific Research and Innovation (UEFISCIDI)
name: University Politechnica of Bucharest
name: TURKEY MEDISEN Ltd
First posted: 2018-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Clinical attachment level (CAL)
timeFrame: before treatment (Baseline), at 6 months post treatment completion
Secondary outcomes:
measure: Changes in Alveolar bone height
timeFrame: before treatment (Baseline), at 6 months post treatment completion
measure: Treatment's influence on bactrial pathogens
timeFrame: before treatment (Baseline), at 6 months post treatment completion
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Concordia Dent Clinic
city: Bucharest
country: Romania
facility: "Carol Davila"University of Medicine and Pharmacy
Study officials:
affiliation: Carol Davila University of Medicine and Pharmacy
name: CORINA MARILENA CRISTACHE
role: PRINCIPAL_INVESTIGATOR
References:
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