NCT05868200

Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis

Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis: a 3 Months Randomized Parallel Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to test efficiency of using toothpaste containing (Ginger) over a period of three month to control on gingival inflammation and plaque accumulation through measuring the clinical periodontal parameters (Gingival Index (GI), Bleeding on probing (BOP) and modified Quigley-Hein Plaque Index (mQHPI ) in comparison with Colgate total toothpastes in patients with biofilm induced gingivitis.

Detailed description

Objectives: 1. Measuring the clinical periodontal parameter (gingival index) and salivary cytokine IL-1β and superoxide dismutase SOD over a period 3 months before and after using Capitano (ginger containing) and Colgate total toothpastes for patients with gingivitis. 2. Measuring the clinical periodontal parameter ((Gingival Index (GI), Bleeding on probing (BOP) and modified Quigley-HeinPlaque Index (mQHPI )) over a period 3 months before and after using Capitano (ginger containing) and Colgate total toothpastes for patients with gingivitis by ELISA. 3. correlation between ( Interleukin 1 beta and SOD) and clinical periodontal parameters

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	Capitano zenzero toothpaste	Filming toothpate formulation, enriched with 3%ginger as active ingredient and Zinc coco sulfate as surfactant, cleansing and emulsifying agent. Subjectswill then be given the test intervention, Capitano zenzero toothpaste, and will be asked to brush with it for two minute twice per day and will be instructed torefrain from eating and drinking for 30 min after brushing. participants will be received a toothbrush with medium-hardness bristles .the bass technique method of brushing by was comprehensively explained to all participants.. Next, the participants will be re-evaluated after 3 months .
DRUG	Colgate total toothpaste	Subjects will then be given Colgate total toothpaste, as an active comparator, and will be asked to brush with it for two minutes twice per day and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles . participants will be received a toothbrush with medium-hardness bristles .the bass technique method of brushing by was comprehensively explained to all participants.. Next, the participants will be re-evaluated after 3 months .

Timeline

• Start date: 2022-02-12
• Primary completion: 2022-05-20
• Completion: 2022-06-21
• First posted: 2023-05-22
• Last updated: 2023-05-22

Locations

1 site across 1 country: Iraq