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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
University of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MMP8, MMP9

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 20, 2021
Last Updated
July 20, 2021
Sponsor
University of L'Aquila
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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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