N/A
N=38
Local and Systemic Antimicrobials in Non-surgical Periodontal Therapy
Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT05608564 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Pocket Probing Depth (PPD) — 3.932; 4.082; 3.253; 3.294 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Piperacillin and Tazobactam in gel form (Procedure); Amoxicillin and Metronidazole (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Belgrade
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pocket Probing Depth (PPD) |
3.932; 4.082; 3.253; 3.294 | — |
| PRIMARY Change in Clinical Attachment Level (CAL) |
4.4; 4.494; 3.832; 4.035 | — |
| PRIMARY Change in Bleeding On Probing (BOP) |
0.6311; 0.6794; 0.1232; 0.6794 | — |
| PRIMARY Change in Plaque Index (PI) |
0.6537; 0.7041; 0.1005; 0.1147 | — |
| SECONDARY Changes in Relative Expression Levels of Tumor Necrois Factor Alpha (TNF-α) |
0.03347; 0.05048; 0.03483; 0.02407 | — |
| SECONDARY Change in Total Bacterial Load (TBL) |
1.87; 1.79; 1.71; 2.00 | — |
| SECONDARY Changes in Relative Expression Levels of IL-17 |
0.008072; 0.007164; 0.007358; 0.00455 | — |
Summary
The main treatment of every patient with periodontitis is non-surgical periodontal treatment (NSPT) with the ultimate goal to arrest inflammation. Given the biofilm microorganisms associated etiology of the periodontitis, NSPT can be combined with adjunctive antimicrobial therapy. Hence, this randomized clinical trial aims to compare the clinical and microbiological effectiveness and relative expression levels (REL) of proinflammatory cytokines tumor necrosis factor-alpha (TNF-α) and interleukin-17 (IL-17) between local and systemic antibiotics as adjunctive therapy to NSPT in patents with periodontitis stage 3.
Eligibility Criteria
Inclusion Criteria
- Both sexes, 18 - 45 years old
- Willingness to participate in the research, comply with all the study protocols, and sign an informed consent;
- Active periodontitis stage II and III according to the criteria of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions;
- Non-smokers and light smokers (up to 10 cigarettes per day).
Exclusion Criteria
- Presence of systemic diseases known to affect the tooth-supporting apparatus and bone metabolism (such as uncontrolled diabetes mellitus, cancer, immunodeficiency, metabolic bone diseases);
- Patients receiving an immunosuppressive, anti-resorptive, or anti-inflammatory therapy;
- Allergy to penicillin;
- Patients who had undergone periodontal therapy within the last 6 months;
- Use of local and/or systemic antimicrobial agents within the last 6 months;
- Use of oral anti-plaque mouthwash at least one month prior to the study;
- Alcohol or drug abuse;
- Pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT05608564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.