GingivitisPhase 2NCT06211309
The Effects of Green Tea and Salvadora Persica L. in Patients With Gingivitis
A Phase 2 study testing co.mouthwas, Kin and Distilled water in people with Gingivitis, run by University of Baghdad at 1 site in Iraq.
Trial summary
Gingivitis is an inflammatory condition of the gingival tissue, most commonly caused by bacterial infection.The plaque control is considered the most important preventive factor concerning caries, gingivitis, and periodontitis Mechanical means of plaque control, e.g. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- co.mouthwas, Kin and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2024to Jul 2024
- Phase
- Phase 2
- 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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects aged more than 15 years-old who will volunteer to participate.
- Participants who were apparently systemically healthy.
- Not taking antibiotic and anti-inflammatory drugs in the last three months
- Patients having generalized gingivitis with intact periodontium in which they have more than 30% bleeding sites with no PPD >3 mm with no clinical attachment loss according to criteria proposed by
Who cannot join
- Those with history of systemic chronic disease, immunocompromised patients.
- Those currently using any mouthwash.
- Those on antibiotic therapy, anti-inflammatory medications or NSAID during the study and at the last 3 months before the study.
- Those having a history of hypersensitivity to any product used in the present study.
- Those having periodontitis.
- Those who smoker or alcoholism.
Show all 10Show fewer
- handicapped patient or patients with limited manual dexterities.
- pregnant , lactating women or taking contraceptive pills.
- Subjects wearing orthodontic appliances or removable dentures.
- patients unwilling to participate in study.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Aliaa
Baghdad, 10011
Aliaa saeed salman, master, 0771 581 4202 ext. 0096, Alaia.saeed2205@codental.edu.iq
Aliaa saeed salman, master
About this study
Official title: Evaluation of Anti-plaque and Anti-inflammatory Effects of Green Tea and Salvadora Persica L. in Patients With Gingivitis
Gingivitis is an inflammatory condition of the gingival tissue, most commonly caused by bacterial infection.The plaque control is considered the most important preventive factor concerning caries, gingivitis, and periodontitis Mechanical means of plaque control, e.g. tooth brushing, flossing and use of other mechanical devices are the most commonly used methods. However, ideal plaque control solely by mechanical means requires a significant effort and is difficult to achieve.This has led to the introduction of chemical methods of plaque control using antimicrobial agentsMore specifically, chemotherapeutic agents with antimicrobial properties, such as 0.12% chlorhexidine (CHX).chx has side effects encourage the need to develop alternative mouthwashes with similar efficacy but without these issues.hence the mouthwash enriched with a combination of aqueous extracts of Salvadora persica L. and green tea used as a substitution to CHX with minimal side effects .The objective of this study was to investigate the efficacy of the combination of Gt aqueous extract and Sp aqueous extract in reducing plaque buildup and gingivitis for 4 weeks duration.
Read the detailed description
Gingivitis is an inflammatory condition of the gingival tissue, most commonly caused by bacterial infection. Unlike periodontitis, there is no attachment loss and therefore no migration of the junctional epithelium. The condition is restricted to the soft-tissue area of the gingival epithelium and connective tissue.Gingivitis is caused by the microbial plaque deposits located in or close to the gingival sulcus).
The plaque control is considered the most important preventive factor concerning caries, gingivitis, and periodontitis Mechanical means of plaque control, e.g. tooth brushing, flossing and use of other mechanical devices are the most commonly used methods. However, ideal plaque control solely by mechanical means requires a significant effort and is difficult to achieve.This has led to the introduction of chemical methods of plaque control using antimicrobial agentsMore specifically, chemotherapeutic agents with antimicrobial properties, such as 0.12% chlorhexidine (CHX), have been proposed as an adjunct to the standard oral hygiene protocol. chx has side effects encourage the need to develop alternative mouthwashes with similar efficacy but without these issues.
Hence the mouthwash enriched with a combination of aqueous extracts of Salvadora persica L. and green tea used as a substitution to CHX with minimal side effects .
- Conditions
- Gingivitis
- Being tested
- co.mouthwas, Kin, Distilled water
- Keywords
- Dental plaque, Salvadora, Green tea, Mouthwash, Clinical trial
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co.mouthwasDrug
Also called co
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
KinOther
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Distilled waterOther
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
| Study group | Role | What they receive |
|---|---|---|
| co.mouthwash | Active comparator | 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min Receives: Drug: co.mouthwas |
| Kin mouthwash | Placebo comparator | 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min Receives: Other: Kin |
| Distilled water | Placebo comparator | 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min Receives: Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in plaque index
Mean amount plaque between different comparators. Mean amount plaque between different comparators as anti-plaque agent after rinsing with different comparators using means of modified quigely hein plaque index[ Turesky ,1970
Measured: 0-30 days
Secondary outcomes (3)
Change 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: 0-30 Days
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: 0-30 days
Mean relative change in cytokine interleukin-6 level in salivary Fluid
Mean relative change in cytokine interleukin-6 level in salivary Fluid after washing with different mouthwash from baseline at 30 days
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jan 2024
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Saeed Salman, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211309
- Sponsor's protocol ID
- 857623
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anti-plaque and Anti-inflammatory Effects of Green Tea and Salvadora Persica L. in Patients With Gingivitis
- ClinicalTrials.gov ID
- NCT06211309
- Acronym / sponsor ID
- 857623
- Conditions
- Gingivitis
- Keywords
- Dental plaque, Salvadora, Green tea, Mouthwash, Clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 18 Jan 2024 (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.
Gingivitis is an inflammatory condition of the gingival tissue, most commonly caused by bacterial infection.The plaque control is considered the most important preventive factor concerning caries, gingivitis, and periodontitis Mechanical means of plaque control, e.g. tooth brushing, flossing and use of other mechanical devices are the most commonly used methods. However, ideal plaque control solely by mechanical means requires a significant effort and is difficult to achieve.This has led to the introduction of chemical methods of plaque control using antimicrobial agentsMore specifically, chemotherapeutic agents with antimicrobial properties, such as 0.12% chlorhexidine (CHX).chx has side effects encourage the need to develop alternative mouthwashes with similar efficacy but without these issues.hence the mouthwash enriched with a combination of aqueous extracts of Salvadora persica L. and green tea used as a substitution to CHX with minimal side effects .The objective of this study was to investigate the efficacy of the combination of Gt aqueous extract and Sp aqueous extract in reducing plaque buildup and gingivitis for 4 weeks duration.
Detailed description
Gingivitis is an inflammatory condition of the gingival tissue, most commonly caused by bacterial infection. Unlike periodontitis, there is no attachment loss and therefore no migration of the junctional epithelium. The condition is restricted to the soft-tissue area of the gingival epithelium and connective tissue.Gingivitis is caused by the microbial plaque deposits located in or close to the gingival sulcus).
The plaque control is considered the most important preventive factor concerning caries, gingivitis, and periodontitis Mechanical means of plaque control, e.g. tooth brushing, flossing and use of other mechanical devices are the most commonly used methods. However, ideal plaque control solely by mechanical means requires a significant effort and is difficult to achieve.This has led to the introduction of chemical methods of plaque control using antimicrobial agentsMore specifically, chemotherapeutic agents with antimicrobial properties, such as 0.12% chlorhexidine (CHX), have been proposed as an adjunct to the standard oral hygiene protocol. chx has side effects encourage the need to develop alternative mouthwashes with similar efficacy but without these issues.
Hence the mouthwash enriched with a combination of aqueous extracts of Salvadora persica L. and green tea used as a substitution to CHX with minimal side effects .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| co.mouthwash | Active comparator | Drug: co.mouthwas15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min |
| Kin mouthwash | Placebo comparator | Other: Kin15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min |
| Distilled water | Placebo comparator | Other: Distilled water15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects aged more than 15 years-old who will volunteer to participate.
- Participants who were apparently systemically healthy.
- Not taking antibiotic and anti-inflammatory drugs in the last three months
- Patients having generalized gingivitis with intact periodontium in which they have more than 30% bleeding sites with no PPD >3 mm with no clinical attachment loss according to criteria proposed by
Key exclusion criteria (10 listed)
- Those with history of systemic chronic disease, immunocompromised patients.
- Those currently using any mouthwash.
- Those on antibiotic therapy, anti-inflammatory medications or NSAID during the study and at the last 3 months before the study.
- Those having a history of hypersensitivity to any product used in the present study.
- Those having periodontitis.
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 |
|---|---|---|
| co.mouthwasAlso: co15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min | Drug | co.mouthwash |
| Kin15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min | Other | Kin mouthwash |
| Distilled water15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min | Other | Distilled water |
Primary outcome
change in plaque index
Time frame: 0-30 days
Mean amount plaque between different comparators. Mean amount plaque between different comparators as anti-plaque agent after rinsing with different comparators using means of modified quigely hein plaque index[ Turesky ,1970
3 secondary outcomes
Change in BOP score
Time frame: 0-30 Days
change in Gingival index
Time frame: 0-30 days
Mean relative change in cytokine interleukin-6 level in salivary Fluid
Time frame: 0-30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing co.mouthwas, Kin and Distilled water 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 10 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in plaque index (time frame: 0-30 days). 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 30 Jan 2024.