Periodontal DiseasePhase 4Perio_topicNCT06836401
Topical Metronidazole vs Control in Reducing Periodontal Pockets in a Split Mouth Clinical Trial
A Phase 4 study testing Root scaling and Topical Gel in people with Periodontal Disease and Periodontal Inflammation, run by University of Salamanca at 1 site in Spain.
Trial summary
The effect of both the mechanical treatment and the topical metronidazol in reduccing the inflammation and depth of the periodontal pockets were assessed on the first bicuspids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease, Periodontal Inflammation
- What is being tested?
- Root scaling and Topical Gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2018to 10 Nov 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontal patients with all first premolars suffering from moderate periodontal pockets (>4mm of probing depth)
Who cannot join
- No patients received antibiotics nor periodontal treatment in the previous 6 months
Trial locations and contacts
1 site in 1 country.
Spain1 site
Dental School of the Faculty of Medicine
Salamanca, Salamanca, 37007
About this study
Official title: Effect of Topical Metronidazole in Reducing Periodontal Probing Depth: A Split Mouth Clinical Trial
The effect of both the mechanical treatment and the topical metronidazol in reduccing the inflammation and depth of the periodontal pockets were assessed on the first bicuspids.
- Conditions
- Periodontal Disease, Periodontal Inflammation
- Being tested
- Root scaling, Topical Gel
- Keywords
- periodontal pocket, periodontal disease, periodontal inflammation
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root scalingProcedure or surgery
Scaling and root planing is a deep cleaning below the gumline used to remove plaque and tartar that cover the root in the periodontal pockets. This intervention is carried out in both control and experimental sites
Topical GelDrug
A gel (experimental: metronidazole VS control: carbopol) is introduced in the recently cleaned periodontal pocket. The allocation of either experimental or control gel was distributed randomly, being masked both the patient and the clinician.
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Experimental | These periodontal pockets will be treated with a metronidazole-based gel Receives: Procedure: Root scaling; Drug: Topical Gel |
| Carbopole | Sham comparator | These deep periodontal pockets (>4mm) are treated with a placebo gel made of carbopol gel Receives: Procedure: Root scaling; Drug: Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Probing depth is assessed at 6 points around the first bicuspids (mesiovestibular, midvestibular, distovestibular, mesiolingual, midlingual, distolingual)
Measured: Both one month and three months after root scaling
Mieloperoxidase ng/mL
The determination of the quantity of mieloperoxidase ng/mL was assessed from the crevicular fluid of the treated bicuspids
Measured: Both one and three months after root scaling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start10 Oct 2018
- Primary completion10 Oct 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
- Investigators
- Javier Montero, Main Researcher, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836401
- Sponsor's protocol ID
- USAL_Nº201700008745
- Acronym
- Perio_topic
- Status last verified
- Jul 2025
- First submitted
- 14 Feb 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This work is planned to be a PhD dissertation and we are not sure if sharing data would hamper the originality of the future thesis
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Metronidazole in Reducing Periodontal Probing Depth: A Split Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT06836401
- Acronym / sponsor ID
- Perio_topic / USAL_Nº201700008745
- Conditions
- Periodontal Disease, Periodontal Inflammation
- Keywords
- periodontal pocket, periodontal disease, periodontal inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 20 Feb 2025 (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.
The effect of both the mechanical treatment and the topical metronidazol in reduccing the inflammation and depth of the periodontal pockets were assessed on the first bicuspids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Experimental | Procedure: Root scaling, Drug: Topical GelThese periodontal pockets will be treated with a metronidazole-based gel |
| Carbopole | Sham comparator | Procedure: Root scaling, Drug: Topical GelThese deep periodontal pockets (>4mm) are treated with a placebo gel made of carbopol gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Periodontal patients with all first premolars suffering from moderate periodontal pockets (>4mm of probing depth)
Key exclusion criteria (1 listed)
- No patients received antibiotics nor periodontal treatment in the previous 6 months
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 |
|---|---|---|
| Root scalingScaling and root planing is a deep cleaning below the gumline used to remove plaque and tartar that cover the root in the periodontal pockets. This intervention is carried out in both control and experimental sites | Procedure or surgery | Carbopole, Metronidazole |
| Topical GelA gel (experimental: metronidazole VS control: carbopol) is introduced in the recently cleaned periodontal pocket. The allocation of either experimental or control gel was distributed randomly, being masked both the patient and the clinician. | Drug | Carbopole, Metronidazole |
Primary outcome
Probing depth
Time frame: Both one month and three months after root scaling
Probing depth is assessed at 6 points around the first bicuspids (mesiovestibular, midvestibular, distovestibular, mesiolingual, midlingual, distolingual)
Mieloperoxidase ng/mL
Time frame: Both one and three months after root scaling
The determination of the quantity of mieloperoxidase ng/mL was assessed from the crevicular fluid of the treated bicuspids
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 24 Jul 2025.
- Individual participant dataSharing planned: Undecided. This work is planned to be a PhD dissertation and we are not sure if sharing data would hamper the originality of the future thesis
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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.
Javier Montero, Main Researcher principal investigator
University of Salamanca
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 Root scaling and Topical Gel in people with Periodontal Disease and Periodontal Inflammation, run by University of Salamanca at 1 site in Spain.
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 1 inclusion and 1 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 24 Jul 2025. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Probing depth (time frame: Both one month and three months after root scaling). The study lists 2 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 24 Jul 2025.