An interventional study of Vitacare and Vibramycin + Fasigyn in Probiotics, Antibiotics and Adjuvant, sponsored by October 6 University. Recruiting at 1 site in Egypt. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by October 6 University · Not applicable, Interventional, and Treatment
The aim of the present study is to evaluate and compare the clinical and biochemical effectiveness of systemic probiotics versus systemic antibiotics when used as adjuncts to nonsurgical periodontal treatment, scaling and root planing (SRP) in adult smoker patients diagnosed with Stage II, Grade B periodontitis
Periodontitis is a chronic, multifactorial inflammatory disease associated with dysbiotic subgingival biofilm and characterized by progressive destruction of the tooth-supporting tissues, including gingiva, periodontal ligament, cementum, and alveolar bone, ultimately leading to clinical attachment loss and potential tooth loss if left untreated.
This inflammatory cascade results in excessive production of pro-inflammatory mediators including interleukin-1β, interleukin-6 (IL-6), tumor necrosis factor-alpha, and matrix metalloproteinases (MMPs), which play a central role in collagen degradation and alveolar bone resorption. Elevated levels of IL-6 and MMPs in gingival crevicular fluid (GCF) have been strongly correlated with periodontal tissue destruction and disease activity, rendering them reliable biochemical markers for evaluating disease progression and therapeutic response.
Probiotics are defined as live microorganisms which, when administered in adequate amounts, confer health benefits on the host.
Unlike antibiotics, probiotics aims to restore microbial balance and modulate host response rather than simply eradicate bacteria, thereby addressing both microbial dysbiosis and exaggerated inflammation.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 30 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →October 6 University is the lead sponsor of 148 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Patients will be treated with non-surgical treatment modality plus administration of vitacare advanced probiotic, capsules, once daily for 10 days.
Drug: Vitacare
Patients will be treated with non-surgical treatment modality plus administration of Vibramycin 100 mg capsules twice daily for seven days and Fasigyn 500mg tablets, once daily for four days.
Drug: Vibramycin + Fasigyn
Patients will be treated with only non-surgical treatment modality.
Procedure: Non-surgical treatment modality
Patients will be treated with non-surgical treatment modality plus administration of vitacare advanced probiotic, capsules, once daily for 10 days.
Patients will be treated with non-surgical treatment modality plus administration of Vibramycin 100 mg capsules twice daily for seven days and Fasigyn 500mg tablets, once daily for four days.
Patients will be treated with only non-surgical treatment modality.
Change in Clinical Attachment Level
Change from baseline in clinical attachment level will be measured in millimeters from the cementoenamel junction to the base of the periodontal pocket using a periodontal probe. A reduction in this distance indicates clinical attachment gain.
Time frame: 6 months after treatment
Change in Periodontal Probing Depth
Change from baseline in periodontal probing depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a periodontal probe. A reduction indicates improvement.
Time frame: 6 months after treatment
Change in Gingival Index
Change from baseline in Gingival Index, scored from 0 (normal gingiva) to 3 (severe gingival inflammation with a tendency toward spontaneous bleeding). Lower scores indicate less gingival inflammation.
Time frame: 6 months after treatment
Change in Plaque Index
Change from baseline in Plaque Index, scored from 0 (no plaque) to 3 (abundant plaque accumulation). Lower scores indicate less plaque accumulation.
Time frame: 6 months after treatment
Change in Gingival Crevicular Fluid Matrix Metalloproteinase Level
Change from baseline in gingival crevicular fluid matrix metalloproteinase concentration will be measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: 6 months after treatment
Change in Gingival Crevicular Fluid Interleukin-6 Level
Change from baseline in gingival crevicular fluid interleukin-6 (IL-6) concentration will be measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: 6 months after treatment
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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