Ignite Creation Date:
2024-05-06 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03656484
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2018-08-29
Brief Title:
New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin
Sponsor:
Concordia Dent Srl
Organization:
Concordia Dent Srl
Study Overview
Official Title:
Innovative Technology for Assessing the Periodontal Disease and New Periodontitis Treatment Based on Hyaluronic Acid and Melatonin
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAMELDENT
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 n25 patients and Tetracycline Metronidazole Melatonin Hyaluronic Acid paste TM-MHa n25 patients
A statistical evaluation of data recorded during the entire follow-up period will be performed
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 n25 patients and Tetracycline Metronidazole Melatonin Hyaluronic Acid paste TM-MHa n25 patients
A statistical evaluation of data recorded during the entire follow-up period will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None