Back to resultsAnti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 3
Locations
Iraq
Study Type
Interventional
Intervention
Capitano zenzero toothpaste
Colgate total toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility Criteria
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. 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.
Sites / Locations
- Zainab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Capitano zenzero toothpaste
Colgate total toothpaste
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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
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]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05868200
Brief Title
Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis
Official Title
Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis: a 3 Months Randomized Parallel Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 12, 2022 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
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.
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.
correlation between ( Interleukin 1 beta and SOD) and clinical periodontal parameters
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
80 subjects with plaque induced gingivitis, caused by accumulation of plaque, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated for two groups, each group received a similar number of subjects (n=40) with a 1:1 allocation.
Masking
ParticipantInvestigator
Masking Description
The products will be packaged in such a way that they are not recognizable neither by the operator, nor by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capitano zenzero toothpaste
Arm Type
Experimental
Arm Description
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.
Arm Title
Colgate total toothpaste
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capitano zenzero toothpaste
Other Intervention Name(s)
Ginger toothpaste
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
Colgate total toothpaste
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Change in Gingival index
Description
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.
Time Frame
0 ,3 months
Title
Mean relative changes in Interleukin 1 beta level in salivary Fluid.
Description
Mean relative changes in Interleukin 1 beta level in salivary fluid after brushing with different comparators from baseline at 3 months.
Time Frame
0 ,3 months
Title
Mean relative changes in superoxide dismutase SOD level in salivary Fluid.
Description
Mean relative changes in superoxide dismutase SOD level in salivary fluid after brushing with different comparators from baseline at 3 months.
Time Frame
0 ,3 months
Secondary Outcome Measure Information:
Title
Changes in BOP score
Description
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
Time Frame
0 ,3 months
Title
Mean amount plaque between different comparators.
Description
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]
Time Frame
0 ,3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zainab Al ALawi, H. diploma
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zainab
City
Baghdad
Country
Iraq
12. IPD Sharing Statement
Learn more about this trial
Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis
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