PeriodontitisPhase 4NCT04983849
Evaluation of Metronidazole Hydrogel 25% in Stage II and III Periodontitis
A Phase 4 study testing metronidazole hydrogel and scaling and root planning in people with Periodontitis, run by University of L'Aquila at 1 site in Italy.
Trial summary
A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- metronidazole hydrogel and scaling and root planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jul 2021to 7 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 10% of sites with survey depth 5 mm
- Comparable pockets in 4 mouth quadrants
- Health at systemic level
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effects of Subgingival Administration of Metronidazole Hydrogel 25% in Stage II and III Periodontitis: Randomized, Split Mouth, Single-blind Trial.
A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- metronidazole hydrogel, scaling and root planning
- Keywords
- Periodontitis, Periodontal disease
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metronidazole hydrogelDrug
Also called Non Surgical Periodontal Therapy
scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket
scaling and root planningProcedure or surgery
scaling and root planning
| Study group | Role | What they receive |
|---|---|---|
| hydrogel metronidazole 25% | Active comparator | metronidazole hydrogel in adjunct to non surgical periodontal therapy Receives: Drug: metronidazole hydrogel |
| scaling and root planing | Active comparator | the only use of scaling and root planing Receives: Procedure: scaling and root planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of MMP8
matrix metalloproteinases (ng/ml)
Measured: baseline - 1 week
Concentration of MMP9
matrix metalloproteinases (ng/ml)
Measured: baseline - 1 week
Concentration of IL1
interleukin (pg/ml)
Measured: baseline - 1 week
Concentration of IL6
interleukin (pg/ml)
Measured: baseline - 1 week
Concentration of IL8
interleukin (pg/ml)
Measured: baseline - 1 week
Concentration of IL17
interleukin (pg/ml)
Measured: baseline - 1 week
Concentration of TNF alfa
tumor necrosis factor alfa (pg/ml)
Measured: baseline - 1 week
Concentration of RANK-L
Receptor activator of nuclear factor kappa-Β ligand (pg/ml)
Measured: baseline - 1 week
Concentration of OPG
osteoprotegerin (pg/ml)
Measured: baseline - 1 week
Secondary outcomes (5)
CAL
clinical attack level (mm)
Measured: baseline - 1 week
PPD
Probing Pocket Depth (mm)
Measured: baseline - 1 week
GI
gingival index (0-3)
Measured: baseline - 1 week
FMPS
full mouth plaque score (0-100%)
Measured: baseline - 1 week
FMBS
full mouth bleeding score (0-100%)
Measured: baseline - 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start7 Jul 2021
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Marchetti, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983849
- Sponsor's protocol ID
- Prot. RCT 001/2021
- Status last verified
- Dec 2023
- First submitted
- 20 Jul 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effects of Subgingival Administration of Metronidazole Hydrogel 25% in Stage II and III Periodontitis: Randomized, Split Mouth, Single-blind Trial.
- ClinicalTrials.gov ID
- NCT04983849
- Acronym / sponsor ID
- Prot. RCT 001/2021
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Periodontal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrogel metronidazole 25% | Active comparator | Drug: metronidazole hydrogelmetronidazole hydrogel in adjunct to non surgical periodontal therapy |
| scaling and root planing | Active comparator | Procedure: scaling and root planningthe only use of scaling and root planing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 10% of sites with survey depth 5 mm
- Comparable pockets in 4 mouth quadrants
- Health at systemic level
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metronidazole hydrogelAlso: Non Surgical Periodontal Therapyscaling and root planning in adjunct to the use of metronidazole in the periodontal pocket | Drug | hydrogel metronidazole 25% |
| scaling and root planningscaling and root planning | Procedure or surgery | scaling and root planing |
Primary outcome
Concentration of MMP8
Time frame: baseline - 1 week
matrix metalloproteinases (ng/ml)
Concentration of MMP9
Time frame: baseline - 1 week
matrix metalloproteinases (ng/ml)
Concentration of IL1
Time frame: baseline - 1 week
interleukin (pg/ml)
Concentration of IL6
Time frame: baseline - 1 week
interleukin (pg/ml)
Concentration of IL8
Time frame: baseline - 1 week
interleukin (pg/ml)
Concentration of IL17
Time frame: baseline - 1 week
interleukin (pg/ml)
Concentration of TNF alfa
Time frame: baseline - 1 week
tumor necrosis factor alfa (pg/ml)
Concentration of RANK-L
Time frame: baseline - 1 week
Receptor activator of nuclear factor kappa-Β ligand (pg/ml)
Concentration of OPG
Time frame: baseline - 1 week
osteoprotegerin (pg/ml)
5 secondary outcomes
CAL
Time frame: baseline - 1 week
PPD
Time frame: baseline - 1 week
GI
Time frame: baseline - 1 week
FMPS
Time frame: baseline - 1 week
FMBS
Time frame: baseline - 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metronidazole hydrogel and scaling and root planning in people with Periodontitis, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of MMP8 (time frame: baseline - 1 week). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.