Clinical trial

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

Name

523622

Description

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.

Trial arms

Trial start

2022-02-12

Estimated PCD

2022-05-20

Trial end

2022-06-21

Status

Completed

Phase

Early phase I

Treatment

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 .

Arms:

Capitano zenzero toothpaste

Other names:

Ginger toothpaste

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 .

Arms:

Colgate total toothpaste

Size

Primary endpoint

Change in Gingival index

0 ,3 months

Mean relative changes in Interleukin 1 beta level in salivary Fluid.

0 ,3 months

Mean relative changes in superoxide dismutase SOD level in salivary Fluid.

0 ,3 months

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}

Updated at

2023-05-22

1 organization

2 products

1 indication

Organization

University of Baghdad

Product

Capitano zenzero toothpaste

Indication

Gingivitis

Product

Colgate Total Toothpaste