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

Phase 3

Completed

Interventions: Drug: Capitano zenzero toothpaste
Drug: Colgate total toothpaste

Brief 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

Recruitment & Eligibility

Inclusion Criteria

Subjects aged 20-35 who will volunteer to participate.
Apparently good general health.
Patients with gingivitis (having ≥30% bleeding sites with no PPD >3 mm, intact periodontium and no loss of periodontal attachment).
Those with a minimum of 20 natural teeth.

Exclusion Criteria

1. Those with chronic disease, immunocompromised patients, pregnant, on contraceptive and lactating women.
2. Those currently using any mouthwash. 3. Those on antibiotic therapy and anti-inflammatory medications during the study and at the last 2 months before the study.
3. Those having a history of hypersensitivity to any product used in the present study.
4. Those with a recent tooth extraction. 6. Those having periodontitis. 7. Those who smoker or alcoholism. 8. Those with extensive untreated dental caries, diseases of hard and soft palate and subjects wearing orthodontic appliances, removable dentures, implant, crown and bridge or presenting with abnormal salivary flow.

Arm && Interventions

Group	Intervention	Description
Capitano zenzero toothpaste	Capitano zenzero toothpaste	Participants will be given the test interventions, Capitano zenzero toothpaste, and will be asked to brushing teeth with this product for two minutes twice per day and will be instructed to refrain from eating and drinking for 30 min after rinsing.
Colgate total toothpaste	Colgate total toothpaste	Participants will be given the test interventions, Colgate total toothpaste, and will be asked to brushing teeth with this product for two minutes twice per day and will be instructed to refrain from eating and drinking for 30 min after rinsing.

Primary Outcome Measures

Name	Time	Method
Change in Gingival index	0 ,3 months	Subjects will undergo the measurement of gingival index according to Loe \& Silness, designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency and bleeding on probing. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva. Data will be collected based on four possible clinical conditions: 0=Normal gingiva1=Mild Inflammation-Slight change in color, Slight odema. No bleeding on probing2=Moderate inflammation-redness,odema and glazing. Bleeding on probing 3=Sever inflammation-marked redness and edema.Ulceration.Tendency to spontaneous bleeding.
Mean relative changes in Interleukin 1 beta level in salivary Fluid.	0 ,3 months	Mean relative changes in Interleukin 1 beta level in salivary fluid after brushing with different comparators from baseline at 3 months.
Mean relative changes in superoxide dismutase SOD level in salivary Fluid.	0 ,3 months	Mean relative changes in superoxide dismutase SOD level in salivary fluid after brushing with different comparators from baseline at 3 months.

Secondary Outcome Measures

Name	Time	Method
Mean amount plaque between different comparators.	0 ,3 months	Mean amount plaque between different comparators as anti-plaque agent after brushing with different comparators using means of modified quigely hein plaque index\[ Turesky ,1970\]
Changes in BOP score	0 ,3 months	For recording BOP score, the periodontal probe was inserted with gentle force into the sulcus/pocket until minimal resistance was felt. The probing force presumably was ranging between 20 to 25g. The examination started from the distal surface of the right upper 7 moving mesially to measure all the existing teeth. For each tooth, 6 surfaces were examined; the surface that displayed bleeding on probing was scored 1 and the surface with no bleeding was scored 0