Effectiveness of Pulling Oil Versus Chlorhexidine Mouthwash in reducing plaque induced gingivitis: A RANDOMISED CONTROLLED TRIAL.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The primary outcomes of this study include the reduction in Plaque Index (PI) and Gingival Index (GI) scores in both groups over time, along with the identification of the antibacterial efficacy of pulling oil compared to chlorhexidine.
Study Overview
Brief Summary
This randomized parallel active-controlled clinical trial aims to evaluate the effectiveness of pulling oil mouthwash versus chlorhexidine mouthwash in reducing plaque-induced gingivitis. The study will include systemically healthy adults (18–60 years) with mild-to-moderate gingivitis, who will be randomly assigned to either the pulling oil mouthwash group or the chlorhexidine mouthwash group. The primary outcomes include the reduction in Plaque Index (PI) and Gingival Index (GI) scores at baseline, 7th day and 14th day, along with the identification of the antibacterial efficacy of pulling oil. Secondary outcomesfocus on identifying safer alternatives to conventional mouthwashes and understanding the role of pulling oil in oral hygiene practices. The study will follow a single-blind design, with participants blinded to the mouthwash used. Randomization will be conducted using a computer-generated sequence, and allocation concealment will be maintained using sealed opaque envelopes. By integrating clinico-microbiological analysis, behavioral compliance assessment, and cost-effectiveness evaluation, this study aims to provide evidence-based recommendations on the potential role of pulling oil mouthwash in public health dentistry.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion criteria for this study include adults aged 18–60 years with mild-to-moderate plaque-induced gingivitis who are systemically healthy and have not undergone dental scaling in the last three months.
- •Additionally, participants must be willing to provide informed consent.
Exclusion Criteria
- •include individuals with chronic periodontitis or systemic conditions, pregnant or lactating women, smokers or those with tobacco-related habits, and individuals with known allergies to coconut oil or chlorhexidine.
Outcomes
Primary Outcomes
The primary outcomes of this study include the reduction in Plaque Index (PI) and Gingival Index (GI) scores in both groups over time, along with the identification of the antibacterial efficacy of pulling oil compared to chlorhexidine.
Time Frame: These outcomes will be assessed at baseline, 7th day, and 14th day to evaluate the effectiveness of the interventions.
Secondary Outcomes
- The secondary outcomes focus on identifying safer alternatives to conventional mouthwashes for managing plaque-induced gingivitis and improving the understanding of the role of pulling oil in oral hygiene practices. These findings will help assess the long-term potential of pulling oil as an adjunctive oral care solution.(These outcomes will be assessed at baseline, 7th day, and 14th day to evaluate the effectiveness of the interventions.)
Investigators
Poonam
Government Dental College Raipur CG