Assessing the Adjunctive Role of Probiotics in Conjunction with Scaling and Root Planing for management of Chronic Periodontitis and Halitosis: A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Banaras Hindu University
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Change in Probing Pocket Depth (PPD) from baseline to 1, 2, and 3 months.
Overview
Brief Summary
This randomized controlled trial aims to evaluate the adjunctive efficacy of probiotic supplementation alongside conventional scaling and root planing (SRP) in the management of chronic periodontitis and halitosis. A total of 56 participants with moderate to severe periodontitis and clinically confirmed halitosis will be randomly allocated into two groups: one receiving SRP with probiotics and the other receiving SRP alone. The primary outcomes include changes in probing pocket depth (PPD), clinical attachment level (CAL), and halitosis scores assessed via organoleptic method. Secondary outcomes include gingival index (GI), incidence of adverse effects, and patient-reported outcomes. The study aims to determine whether probiotics can enhance periodontal healing and reduce oral malodor beyond the effects of SRP alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults aged 18 to 65 years Patients having moderate to severe chronic generalized periodontitis (more than equal to 3 mm clinical attachment loss involving more than 30 percent of sites) Presence of halitosis, confirmed by organoleptic assessment Patients who had not taken any antibiotics during the previous 3 months or anti-inflammatory drugs in the last month Patients who had not participated in any clinical trial during the previous month Who had not undergone any surgical or non-surgical therapy 6 months prior to the study Ability to provide informed consent for participation in the study.
- •Patients who agreed for regular follow ups.
Exclusion Criteria
- •Patients with history of drug allergy.
- •Pregnant or breastfeeding women.
- •Patients wearing orthodontic appliances or any removable prosthesis Patient with systemic ailments Patients not consenting to participate.
Outcomes
Primary Outcomes
Change in Probing Pocket Depth (PPD) from baseline to 1, 2, and 3 months.
Time Frame: Change in Probing Pocket Depth (PPD) from baseline to 1, 2, and 3 months. | Change in Clinical Attachment Level (CAL) over the same intervals. | Reduction in halitosis scores, assessed using organoleptic method.
Change in Clinical Attachment Level (CAL) over the same intervals.
Time Frame: Change in Probing Pocket Depth (PPD) from baseline to 1, 2, and 3 months. | Change in Clinical Attachment Level (CAL) over the same intervals. | Reduction in halitosis scores, assessed using organoleptic method.
Reduction in halitosis scores, assessed using organoleptic method.
Time Frame: Change in Probing Pocket Depth (PPD) from baseline to 1, 2, and 3 months. | Change in Clinical Attachment Level (CAL) over the same intervals. | Reduction in halitosis scores, assessed using organoleptic method.
Secondary Outcomes
- Change in Gingival Index (GI) from baseline to follow-up visits.
Investigators
Aishwarya Pandey
Banaras Hindu University