GingivitisPhase 3NCT05868200
Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis
A Phase 3 study testing Capitano zenzero toothpaste and Colgate total toothpaste in people with Gingivitis, run by University of Baghdad at 1 site in Iraq.
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… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Capitano zenzero toothpaste and Colgate total toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 12 Feb 2022to 21 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis: a 3 Months Randomized Parallel Clinical Trial
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.
Read the 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
- Conditions
- Gingivitis
- Being tested
- Capitano zenzero toothpaste, Colgate total toothpaste
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capitano zenzero toothpasteDrug
Also called Ginger 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 toothpasteDrug
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 .
| Study group | Role | What they receive |
|---|---|---|
| Capitano zenzero toothpaste | Experimental | 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. Receives: Drug: Capitano zenzero toothpaste |
| Colgate total toothpaste | Active comparator | 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. Receives: Drug: Colgate total toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 ,3 months
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.
Measured: 0 ,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.
Measured: 0 ,3 months
Secondary outcomes (2)
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
Measured: 0 ,3 months
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]
Measured: 0 ,3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start12 Feb 2022
- Primary completion20 May 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Zuhair Alalawi, University of Baghdad
- Investigators
- zainab Al ALawi, H. diploma, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868200
- Sponsor's protocol ID
- 523622
- Status last verified
- May 2023
- First submitted
- 16 Apr 2023
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis: a 3 Months Randomized Parallel Clinical Trial
- ClinicalTrials.gov ID
- NCT05868200
- Acronym / sponsor ID
- 523622
- Conditions
- Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Capitano zenzero toothpaste | Experimental | Drug: Capitano zenzero toothpasteParticipants 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 | Active comparator | Drug: Colgate total toothpasteParticipants 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capitano zenzero toothpasteAlso: Ginger toothpasteFilming 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 . | Drug | Capitano zenzero toothpaste |
| Colgate total toothpasteSubjects 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 . | Drug | Colgate total toothpaste |
Primary outcome
Change in Gingival index
Time frame: 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.
Time frame: 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.
Time frame: 0 ,3 months
Mean relative changes in superoxide dismutase SOD level in salivary fluid after brushing with different comparators from baseline at 3 months.
2 secondary outcomes
Changes in BOP score
Time frame: 0 ,3 months
Mean amount plaque between different comparators.
Time frame: 0 ,3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zainab Al ALawi, H. diploma principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capitano zenzero toothpaste and Colgate total toothpaste in people with Gingivitis, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival index (time frame: 0 ,3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.