Clinical trial NCT05868200: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in Gingival index
timeFrame: 0 ,3 months
measure: Mean relative changes in Interleukin 1 beta level in salivary Fluid.
timeFrame: 0 ,3 months
measure: Mean relative changes in superoxide dismutase SOD level in salivary Fluid.
timeFrame: 0 ,3 months
Secondary outcomes:
measure: Changes in BOP score
timeFrame: 0 ,3 months
measure: Mean amount plaque between different comparators.
timeFrame: 0 ,3 months
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Zainab
Study officials:
affiliation: University of Baghdad
name: zainab Al ALawi, H. diploma
role: PRINCIPAL_INVESTIGATOR
References: