Periodontal DiseasesRCTNCT07282756
Evaluation Of The Efficacy Of Subgingival Application Of Lovastatin Gel As An Adjunct To Non-Surgical Treatment Of Periodontitis In Generally Healthy Smokers And Non-Smokers Patients in Central Europe.
A study testing Subgingival application of 1.2% lovastatin in people with Periodontal Diseases and Periodontitis, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of the study is to evaluate how a gel (1.2% lovastatin) applied under the gum improves the results of classic periodontal treatment (SRP-scaling, root planing). The study involves two groups of adults diagnosed with periodontitis: the first group consists of generally healthy individuals who do not smoke… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Periodontal Disease
- What is being tested?
- Subgingival application of 1.2% lovastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 sitePoland
- Study dates
- 11 Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- generally healthy patients
- diagnosed periodontal disease (at least one pair of non-adjacent sites with PD≥5 mm or CAL ≥4 mm and vertical bone loss ≥ 3 mm)
- no history of periodontal disease treatment
- no history of antibiotic use in the past 6 months
- an eligible tooth must be alive, with no history of endodontic treatment
- non-smoking (group I) or active smokers (group 2)
Who cannot join
- Statin allergy
- receiving systemic statin therapy,
- alcoholics
- immunocompromised patients
- pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rafał Wiench, profesor contact
Poland1 site, 1 recruiting
- Recruiting
Pietrzko Dental Clinic
Bielsko-Biala, Silesian Voivodeship, 43-300
Magdalena Pietrzko, DMD, +48604796143, pietrzkoperio@gmail.com
About this study
Official title: Assessment of Changes in Clinical and Radiological Parameters in Gingival Pockets After Subgingival Application of Lovastatin Gel in Combination With SRP Procedure Compared to SRP and Placebo Gel Application in the Treatment of Periodontal Disease in Generally Healthy Non-smokers and Smokers From Central Europe: a Split-mouth Randomized Controlled Trial.
The aim of the study is to evaluate how a gel (1.2% lovastatin) applied under the gum improves the results of classic periodontal treatment (SRP-scaling, root planing).
The study involves two groups of adults diagnosed with periodontitis: the first group consists of generally healthy individuals who do not smoke tobacco. The second group consists of generally healthy individuals who have been smoking for at least 5 years. Before the study begins, each participant will undergo gum health measurements. Changes in these parameters will be monitored throughout the study. Two teeth will be selected for each participant:
Read more
- a gel containing the medication will be applied under the gum of one tooth
- a gel that looks similar to the medication but does not contain any medicinal substance will be applied under the gum of the second tooth.
Before applying the gel, each participant will undergo subgingival cleaning (SRP) to remove any debris that may prevent the medicine from working.
The study will last six months.
Expected results:
- all participants will experience an improvement in the condition of their gums after treatment
- the effect of treatment will be better in non-smokers than in smokers
- the treatment outcome will be better in the area where the medicated gel was applied compared to areas where the gel without medicinal substances was applied.
- Conditions
- Periodontal Diseases, Periodontitis, Periodontal Disease, Smokers
- Being tested
- Subgingival application of 1.2% lovastatin, Subgingival application of placebo gel
- Keywords
- periodontitis, statins, lovastatin, smoking, periodontal disease
- Medical subject headings
- Periodontal Diseases, Periodontitis, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgingival application of 1.2% lovastatinDrug
Each patient will be assigned 2 sites that meet the inclusion criteria. After the SRP (scaling, root planing) procedure is applied within the qualified gingival pockets, a gel drug (1.2% concentration of lovastatin) will be applied to one site selected by randomization.
Subgingival application of placebo gelDrug
Each patient will be assigned 2 sites that meet inclusion criteria. After the SRP procedure (scaling, root planing) procedure is applied within qualified gingival pockets, placebo gel will be applied to one site selected by randomization.
| Study group | Role | What they receive |
|---|---|---|
| patients generally healthy, non-smokers, diagnosed with periodontal disease | Experimental | Test side- gingival pocket that meets the inclusion criteria and to which a gel containing 1.2% lovastatin will be assigned in patients generally healthy, non-smokers, diagnosed with periodontitis. Receives: Drug: Subgingival application of 1.2% lovastatin |
| Generally healthy patients active smokers with periodontits | Experimental | Test side- gingival pocket that meets the inclusion criteria and to which a gel containing 1.2% lovastatin will be assigned in patients generally healthy,smokers, diagnosed with periodontitis. Receives: Drug: Subgingival application of 1.2% lovastatin |
| Generally healthy patients, active smokers with periodontits | Placebo comparator | control side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, smokers, diagnosed with periodontitis. Receives: Drug: Subgingival application of placebo gel |
| patients generally healthy, non-smokers, diagnosed with periodontitis | Placebo comparator | control side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, non-smokers, diagnosed with periodontitis. Receives: Drug: Subgingival application of placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
the distance between the enamel-cement junction (CEJ) and the bottom of the gingival pocket; expressed in mm
Measured: change from baseline to 6 months after intervention
Probing Depth
the distance between the gingival margin and the bottom of the gingival pocket, measured with a calibrated periodontalprobe, expressed in mm
Measured: change from baseline to 6 months after intervention
modified Sulcus Bleeding Index (mSBI)
an index used to determine the severity of inflammation in the periodontal tissues; determines the percentage of the study area that is inflamed. Expressed as a percentage, where 0% indicates no inflammation and 100% indicates maximum inflammation.
Measured: from baseline to six months after intervention
Plaque Index Pl.I. (Silness i Löe)
an index that evaluates the patient's level of oral hygiene on a numerical scale of 0-3. Optimal hygiene occurs at values <1, while values >1 indicate insufficient hygiene that needs improvement. The higher the value, the worse the hygiene.
Measured: from baseline to 6 months after intervention
Secondary outcomes (1)
Infrabony Defect Depth
a parameter measured as the distance from the edge of the alveolar crest to the bottom of the bony defect; assessed on conebeam computed tomography (CBCT) scanning
Measured: from baseline to six months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start11 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the SRP procedure is applied within the qualified gingival pockets, a gel drug (1.2% concentration of lovastatin) will be applied to the first designated site, and a placebo gel (split-mouth design) will be applied to the second site.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282756
- Sponsor's protocol ID
- 2025/6/5/4
- Acronym
- RCT
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Changes in Clinical and Radiological Parameters in Gingival Pockets After Subgingival Application of Lovastatin Gel in Combination With SRP Procedure Compared to SRP and Placebo Gel Application in the Treatment of Periodontal Disease in Generally Healthy Non-smokers and Smokers From Central Europe: a Split-mouth Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07282756
- Acronym / sponsor ID
- RCT / 2025/6/5/4
- Conditions
- Periodontal Diseases, Periodontitis, Periodontal Disease, Smokers
- Keywords
- periodontitis, statins, lovastatin, smoking, periodontal disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Dec 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 aim of the study is to evaluate how a gel (1.2% lovastatin) applied under the gum improves the results of classic periodontal treatment (SRP-scaling, root planing).
The study involves two groups of adults diagnosed with periodontitis: the first group consists of generally healthy individuals who do not smoke tobacco. The second group consists of generally healthy individuals who have been smoking for at least 5 years. Before the study begins, each participant will undergo gum health measurements. Changes in these parameters will be monitored throughout the study. Two teeth will be selected for each participant:
- a gel containing the medication will be applied under the gum of one tooth
- a gel that looks similar to the medication but does not contain any medicinal substance will be applied under the gum of the second tooth.
Before applying the gel, each participant will undergo subgingival cleaning (SRP) to remove any debris that may prevent the medicine from working.
The study will last six months.
Expected results:
- all participants will experience an improvement in the condition of their gums after treatment
- the effect of treatment will be better in non-smokers than in smokers
- the treatment outcome will be better in the area where the medicated gel was applied compared to areas where the gel without medicinal substances was applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- After the SRP procedure is applied within the qualified gingival pockets, a gel drug (1.2% concentration of lovastatin) will be applied to the first designated site, and a placebo gel (split-mouth design) will be applied to the second site.
| Arm | Type | Receives |
|---|---|---|
| patients generally healthy, non-smokers, diagnosed with periodontal disease | Experimental | Drug: Subgingival application of 1.2% lovastatinTest side- gingival pocket that meets the inclusion criteria and to which a gel containing 1.2% lovastatin will be assigned in patients generally healthy, non-smokers, diagnosed with periodontitis. |
| Generally healthy patients active smokers with periodontits | Experimental | Drug: Subgingival application of 1.2% lovastatinTest side- gingival pocket that meets the inclusion criteria and to which a gel containing 1.2% lovastatin will be assigned in patients generally healthy,smokers, diagnosed with periodontitis. |
| Generally healthy patients, active smokers with periodontits | Placebo comparator | Drug: Subgingival application of placebo gelcontrol side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, smokers, diagnosed with periodontitis. |
| patients generally healthy, non-smokers, diagnosed with periodontitis | Placebo comparator | Drug: Subgingival application of placebo gelcontrol side: gingival pocket that meets the inclusion criteria and to which a placebo gel in patients generally healthy, non-smokers, diagnosed with periodontitis. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- generally healthy patients
- diagnosed periodontal disease (at least one pair of non-adjacent sites with PD≥5 mm or CAL ≥4 mm and vertical bone loss ≥ 3 mm)
- no history of periodontal disease treatment
- no history of antibiotic use in the past 6 months
- an eligible tooth must be alive, with no history of endodontic treatment
Key exclusion criteria (5 listed)
- Statin allergy
- receiving systemic statin therapy,
- alcoholics
- immunocompromised patients
- pregnant or breastfeeding women.
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 |
|---|---|---|
| Subgingival application of 1.2% lovastatinEach patient will be assigned 2 sites that meet the inclusion criteria. After the SRP (scaling, root planing) procedure is applied within the qualified gingival pockets, a gel drug (1.2% concentration of lovastatin) will be applied to one site selected by randomization. | Drug | Generally healthy patients active smokers with periodontits, patients generally healthy, non-smokers, diagnosed with periodontal disease |
| Subgingival application of placebo gelEach patient will be assigned 2 sites that meet inclusion criteria. After the SRP procedure (scaling, root planing) procedure is applied within qualified gingival pockets, placebo gel will be applied to one site selected by randomization. | Drug | Generally healthy patients, active smokers with periodontits, patients generally healthy, non-smokers, diagnosed with periodontitis |
Primary outcome
Clinical Attachment Level
Time frame: change from baseline to 6 months after intervention
the distance between the enamel-cement junction (CEJ) and the bottom of the gingival pocket; expressed in mm
Probing Depth
Time frame: change from baseline to 6 months after intervention
the distance between the gingival margin and the bottom of the gingival pocket, measured with a calibrated periodontalprobe, expressed in mm
modified Sulcus Bleeding Index (mSBI)
Time frame: from baseline to six months after intervention
an index used to determine the severity of inflammation in the periodontal tissues; determines the percentage of the study area that is inflamed. Expressed as a percentage, where 0% indicates no inflammation and 100% indicates maximum inflammation.
Plaque Index Pl.I. (Silness i Löe)
Time frame: from baseline to 6 months after intervention
an index that evaluates the patient's level of oral hygiene on a numerical scale of 0-3. Optimal hygiene occurs at values <1, while values >1 indicate insufficient hygiene that needs improvement. The higher the value, the worse the hygiene.
1 secondary outcome
Infrabony Defect Depth
Time frame: from baseline to six months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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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.
Rafał Wiench, profesor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subgingival application of 1.2% lovastatin in people with Periodontal Diseases and Periodontitis, run by Medical University of Silesia at 1 site in Poland.
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 6 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. 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 Poland. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Pietrzko, DMD (+48604796143, pietrzkoperio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (time frame: change from baseline to 6 months after intervention). The study lists 4 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 20 Feb 2026.