Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Periodontitis treatment, Periodonal pockets, local delivery drugs
Eligibility Criteria
Inclusion Criteria:
- non-smokers
- suffering from chronic periodontitis
Exclusion Criteria:
- any antibiotics taken systematically or locally in the preceding six months
Sites / Locations
- Wroclaw Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Metronidazole
Only SRP
Arm Description
19,8 mg of metronidazole in one polymer matrix
standard non-surgical treatment- scaling/root planing
Outcomes
Primary Outcome Measures
PD
Periodontal pocket depth
API
Approximal Plaque Index
BoP
Bleeding of probing
PBI
Papilla bleeding index
Secondary Outcome Measures
Full Information
NCT ID
NCT03791099
First Posted
December 29, 2018
Last Updated
January 2, 2019
Sponsor
Wroclaw Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03791099
Brief Title
Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.
Official Title
Preparation and Analysis of Material, Biological and Clinical Parameters of Metronidazole-loaded Porous Matrices for Local Periodontitis Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Aim of the study is the efficiency assessment of porous Metronidazole loaded matrix based on gelatin/hydroxyethylcellulose blend in treatment of deep periodontal pockets resulting from severe chronic periodontitis. The matrix was invented and produced in Department of Drug Form Technology, Wroclaw Medical University.
The porous metronidazole (MTZ) loaded matrix was fabricated by the freeze-drying technique. The morphology, mechanical properties, in vitro degradation, MTZ release from dried sponge were evaluated and also the clinical trials were performed.
Patients suffering from chronic periodontitis are examined. To evaluate oral hygiene API (Approximal Plaque Index) and the gum inflammation BOP (Bleeding on Probing) and PBI (Papilla Bleeding Index) indices are used. The clinical examination is performed 3 times. On the first visit the output indicators are defined. The subgingival scaling is performed and Metronidazol on porous matrix is applied to the selected periodontal pockets. 2 control tests of periodontal indices are carried out after one week and one month from the application.
In the control group after scaling/root planing procedure, there is no application of metronidazole.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Periodontitis treatment, Periodonal pockets, local delivery drugs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metronidazole
Arm Type
Experimental
Arm Description
19,8 mg of metronidazole in one polymer matrix
Arm Title
Only SRP
Arm Type
No Intervention
Arm Description
standard non-surgical treatment- scaling/root planing
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
After subgingival ultrasonic scaling is performed, metronidazole in polymer matrix is applied to the selected periodontal pockets.
Primary Outcome Measure Information:
Title
PD
Description
Periodontal pocket depth
Time Frame
4 weeks after the first visit
Title
API
Description
Approximal Plaque Index
Time Frame
4 weeks after the first visit
Title
BoP
Description
Bleeding of probing
Time Frame
4 weeks after the first visit
Title
PBI
Description
Papilla bleeding index
Time Frame
4 weeks after the first visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
non-smokers
suffering from chronic periodontitis
Exclusion Criteria:
any antibiotics taken systematically or locally in the preceding six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marek Ziętek, Prof
Organizational Affiliation
Department of Periodontology, Wroclaw Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Wroclaw Medical University
City
Wroclaw
ZIP/Postal Code
50-425
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23853452
Citation
Pandit N, Dahiya R, Gupta R, Bali D, Kathuria A. Comparative evaluation of locally delivered minocycline and metronidazole in the treatment of periodontitis. Contemp Clin Dent. 2013 Jan;4(1):48-53. doi: 10.4103/0976-237X.111615.
Results Reference
background
PubMed Identifier
26373225
Citation
Da Rocha HA, Silva CF, Santiago FL, Martins LG, Dias PC, De Magalhaes D. Local Drug Delivery Systems in the Treatment of Periodontitis: A Literature Review. J Int Acad Periodontol. 2015 Jul;17(3):82-90.
Results Reference
background
PubMed Identifier
25750745
Citation
Ahmed EM. Hydrogel: Preparation, characterization, and applications: A review. J Adv Res. 2015 Mar;6(2):105-21. doi: 10.1016/j.jare.2013.07.006. Epub 2013 Jul 18.
Results Reference
background
PubMed Identifier
23827565
Citation
Gautam S, Dinda AK, Mishra NC. Fabrication and characterization of PCL/gelatin composite nanofibrous scaffold for tissue engineering applications by electrospinning method. Mater Sci Eng C Mater Biol Appl. 2013 Apr 1;33(3):1228-35. doi: 10.1016/j.msec.2012.12.015. Epub 2012 Dec 8.
Results Reference
background
PubMed Identifier
26289672
Citation
Pachuau L. Recent developments in novel drug delivery systems for wound healing. Expert Opin Drug Deliv. 2015;12(12):1895-909. doi: 10.1517/17425247.2015.1070143. Epub 2015 Aug 4.
Results Reference
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Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.
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