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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05868200
• Other study ID #: 523622
• Status: Completed
• Phase: Phase 3
• Start date: February 12, 2022
• Est. completion date: June 21, 2022

Study information

• Verified date: May 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 21, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Subjects aged 20-35 who will volunteer to participate.

2. Apparently good general health.

3. Patients with gingivitis (having =30% bleeding sites with no PPD >3 mm, intact periodontium and no loss of periodontal attachment).

4. 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.

4. Those having a history of hypersensitivity to any product used in the present study.

5. 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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

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 .
• 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 .

Locations

Country	Name	City	State
Iraq	Zainab	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gingival index	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.	0 ,3 months
Primary	Mean relative changes in Interleukin 1 beta level in salivary Fluid.	Mean relative changes in Interleukin 1 beta level in salivary fluid after brushing with different comparators from baseline at 3 months.	0 ,3 months
Primary	Mean relative changes in superoxide dismutase SOD level in salivary Fluid.	Mean relative changes in superoxide dismutase SOD level in salivary fluid after brushing with different comparators from baseline at 3 months.	0 ,3 months
Secondary	Changes in BOP score	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	0 ,3 months
Secondary	Mean amount plaque between different comparators.	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]	0 ,3 months