Evaluation of Metronidazole Hydrogel 25% in Stage II and III Periodontitis
Primary Purpose
MMP8, MMP9, IL1, IL6, IL8, IL17, TNF ALFA
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
metronidazole hydrogel
scaling and root planning
Sponsored by

About this trial
This is an interventional treatment trial for MMP8, MMP9
Eligibility Criteria
Inclusion Criteria:
- 10% of sites with survey depth 5 mm
- Comparable pockets in 4 mouth quadrants
- Health at systemic level
Exclusion Criteria:
- Changes in oral mucosa
- Depth at the poll 5 mm
- Presence of removable prostheses or orthodontic equipment
- Allergies to even a single component of a product in testing• Antibiotic-based treatments during the 6 months preceding the start of testing
- History of previous periodontal treatments in the 12 months preceding the start of the study
Sites / Locations
- University of L'Aquila, division of periodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
hydrogel metronidazole 25%
scaling and root planing
Arm Description
metronidazole hydrogel in adjunct to non surgical periodontal therapy
the only use of scaling and root planing
Outcomes
Primary Outcome Measures
MMP8, MMP9
matrix metalloproteinases
IL1, IL6,IL8,IL17
interleukin
TNF alfa
tumor necrosis factor alfa
RANK-L
Receptor activator of nuclear factor kappa-Β ligand
OPG
osteoprotegerin
Secondary Outcome Measures
CAL
clinical attack level
PPD
Probing Pocket Depth
GI
gingival index
FMPS
full mouth plaque score
FMBS
full mouth bleeding score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04983849
Brief Title
Evaluation of Metronidazole Hydrogel 25% in Stage II and III Periodontitis
Official Title
Evaluation of Effects of Subgingival Administration of Metronidazole Hydrogel 25% in Stage II and III Periodontitis: Randomized, Split Mouth, Single-blind Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
July 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of L'Aquila
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.
Detailed Description
A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis in stage II and III.
At least 40 volunteers between the age of 18 and 80, will be enlisted, with the need to perform the SRP. In half of the mouth will be used the metronidazole hydrogel 25%, while in the other half no drugs will be used of delivered.
The study will be carried out in accordance with the Helsinki Declaration and the Protocol will be submitted to the Internal Review Board of the University to obtain authorization. Afterwards, the protocol will be recorded on the databa-se clinicaltrials.gov for clinical trials.
The protocol respects the SPIRIT parameters for the compilation of protocols on clinical trials and the study will respect the parameters of CONSORT sta-tement on randomized clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MMP8, MMP9, IL1, IL6, IL8, IL17, TNF ALFA, RANK-L, OPG, CAL, PPD, GI, FMPS, FMBS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hydrogel metronidazole 25%
Arm Type
Active Comparator
Arm Description
metronidazole hydrogel in adjunct to non surgical periodontal therapy
Arm Title
scaling and root planing
Arm Type
Active Comparator
Arm Description
the only use of scaling and root planing
Intervention Type
Drug
Intervention Name(s)
metronidazole hydrogel
Other Intervention Name(s)
Non Surgical Periodontal Therapy
Intervention Description
scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket
Intervention Type
Procedure
Intervention Name(s)
scaling and root planning
Intervention Description
scaling and root planning
Primary Outcome Measure Information:
Title
MMP8, MMP9
Description
matrix metalloproteinases
Time Frame
baseline - 1 week
Title
IL1, IL6,IL8,IL17
Description
interleukin
Time Frame
baseline - 1 week
Title
TNF alfa
Description
tumor necrosis factor alfa
Time Frame
baseline - 1 week
Title
RANK-L
Description
Receptor activator of nuclear factor kappa-Β ligand
Time Frame
baseline - 1 week
Title
OPG
Description
osteoprotegerin
Time Frame
baseline - 1 week
Secondary Outcome Measure Information:
Title
CAL
Description
clinical attack level
Time Frame
baseline - 1 week
Title
PPD
Description
Probing Pocket Depth
Time Frame
baseline - 1 week
Title
GI
Description
gingival index
Time Frame
baseline - 1 week
Title
FMPS
Description
full mouth plaque score
Time Frame
baseline - 1 week
Title
FMBS
Description
full mouth bleeding score
Time Frame
baseline - 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
10% of sites with survey depth 5 mm
Comparable pockets in 4 mouth quadrants
Health at systemic level
Exclusion Criteria:
Changes in oral mucosa
Depth at the poll 5 mm
Presence of removable prostheses or orthodontic equipment
Allergies to even a single component of a product in testing• Antibiotic-based treatments during the 6 months preceding the start of testing
History of previous periodontal treatments in the 12 months preceding the start of the study
Facility Information:
Facility Name
University of L'Aquila, division of periodontology
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of Metronidazole Hydrogel 25% in Stage II and III Periodontitis
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