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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subgingival application of 1.2% lovastatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Attachment Level | the distance between the enamel-cement junction (CEJ) and the bottom of the gingival pocket; expressed in mm | 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 | 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. | 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. | from baseline to 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from baseline to six months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magdalena Pietrzko, DMD | Contact | +48604796143 | pietrzkoperio@gmail.com | |
| Rafał Wiench, profesor | Contact | rwiench@sum.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pietrzko Dental Clinic | Recruiting | Bielsko-Biala | Silesian Voivodeship | 43-300 | Poland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol and Statistical Analysis Plan |
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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.
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|
| Subgingival application of placebo gel | Drug | 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. |
|
| Oct 8, 2025 |
| Oct 10, 2025 |
| Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Results module | Nov 28, 2025 | Nov 28, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2025 | Oct 8, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008148 | Lovastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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