ProbioticsNCT07923695
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
A study testing Vitacare, Vibramycin + Fasigyn and Non-surgical treatment modality in people with Probiotics and Antibiotics, run by October 6 University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Probiotics, Antibiotics, Adjuvant
- What is being tested?
- Vitacare, Vibramycin + Fasigyn and Non-surgical treatment modality
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Jun 2027
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-50 years
- Periodontitis male patients diagnosed as they having Stage II, Grade B periodontitis
- Clinical attachment loss 3-4 mm
- Radiographic bone loss in coronal third.
- Current smokers or non-smokers.
Who cannot join
- Systemic diseases affecting periodontal health.
- Periodontal therapy within last 6 months.
- Use of antibiotics, probiotics or anti-inflammatory medication within last 3 months.
- History of allergy to the prescribed study medications.
- Patients unwilling to comply with study instructions or follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University
Cairo, 12511
Ahlam A Al-shawafi, B.Sc, 00201156330099, Periodentistahlam@gmail.com
Osama S El-Shall, MD
About this study
Official title: Clinical and Biochemical Evaluation of Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
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
Read the detailed description
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.
- Conditions
- Probiotics, Antibiotics, Adjuvant, Non-surgical, Periodontal Treatment, Smokers
- Being tested
- Vitacare, Vibramycin + Fasigyn, Non-surgical treatment modality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitacareDrug
Patients will be treated with non-surgical treatment modality plus administration of vitacare advanced probiotic, capsules, once daily for 10 days.
Vibramycin + FasigynDrug
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.
Non-surgical treatment modalityProcedure or surgery
Patients will be treated with only non-surgical treatment modality.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Probiotic group) | Experimental | Patients will be treated with non-surgical treatment modality plus administration of vitacare advanced probiotic, capsules, once daily for 10 days. Receives: Drug: Vitacare |
| Group II (Antibiotic group) | Experimental | 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. Receives: Drug: Vibramycin + Fasigyn |
| Group III (Control group) | Active comparator | Patients will be treated with only non-surgical treatment modality. Receives: Procedure: Non-surgical treatment modality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after treatment
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Sep 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticsStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahlam Ali Abdulkareem Al-shawafi, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923695
- Sponsor's protocol ID
- 6 (24/06/2026)
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
- ClinicalTrials.gov ID
- NCT07923695
- Acronym / sponsor ID
- 6 (24/06/2026)
- Conditions
- Probiotics, Antibiotics, Adjuvant, Non-surgical, Periodontal Treatment, Smokers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 6 Nov 2026 (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 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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Probiotic group) | Experimental | Drug: VitacarePatients will be treated with non-surgical treatment modality plus administration of vitacare advanced probiotic, capsules, once daily for 10 days. |
| Group II (Antibiotic group) | Experimental | Drug: Vibramycin + FasigynPatients 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. |
| Group III (Control group) | Active comparator | Procedure: Non-surgical treatment modalityPatients will be treated with only non-surgical treatment modality. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 25-50 years
- Periodontitis male patients diagnosed as they having Stage II, Grade B periodontitis
- Clinical attachment loss 3-4 mm
- Radiographic bone loss in coronal third.
- Current smokers or non-smokers.
Key exclusion criteria (5 listed)
- Systemic diseases affecting periodontal health.
- Periodontal therapy within last 6 months.
- Use of antibiotics, probiotics or anti-inflammatory medication within last 3 months.
- History of allergy to the prescribed study medications.
- Patients unwilling to comply with study instructions or follow-up visits
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 |
|---|---|---|
| VitacarePatients will be treated with non-surgical treatment modality plus administration of vitacare advanced probiotic, capsules, once daily for 10 days. | Drug | Group 1 (Probiotic group) |
| Vibramycin + FasigynPatients 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 | Group II (Antibiotic group) |
| Non-surgical treatment modalityPatients will be treated with only non-surgical treatment modality. | Procedure or surgery | Group III (Control group) |
Primary outcome
Change in Clinical Attachment Level
Time frame: 6 months after treatment
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.
5 secondary outcomes
Change in Periodontal Probing Depth
Time frame: 6 months after treatment
Change in Gingival Index
Time frame: 6 months after treatment
Change in Plaque Index
Time frame: 6 months after treatment
Change in Gingival Crevicular Fluid Matrix Metalloproteinase Level
Time frame: 6 months after treatment
Change in Gingival Crevicular Fluid Interleukin-6 Level
Time frame: 6 months after treatment
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 6 Nov 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitacare, Vibramycin + Fasigyn and Non-surgical treatment modality in people with Probiotics and Antibiotics, run by October 6 University at 1 site in Egypt.
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 5 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 6 Nov 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 Egypt. 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. 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 Ahlam A Al-shawafi, B.Sc (00201156330099, Periodentistahlam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Attachment Level (time frame: 6 months after treatment). 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 6 Nov 2026.