Periodontal DiseasesPhase 2NCT03790904
Anti Plaque Efficacy of Salvadora Persica L. and Green Tea Mouthwash
A Phase 2 study testing Co., Kin and Distilled water in people with Periodontal Diseases, run by University of Baghdad at 1 site in Iraq.
Trial summary
Periodontal diseases and caries are essentially initiated and progressed by accumulation of dental plaque. Thus, daily effective plaque control is valuable as a preventive measure and maintaining oral health. Read more about this study
- Who is it for?
- Ages 20 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Co., Kin and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIraq
- Study dates
- 10 Jan 2019to 9 Apr 2019
- 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 20 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants should be medically healthy.
- Participants should have more than 20 teeth.
Who cannot join
- Participants who have active cavity caries and/or periodontal disease.
- Participants who have ongoing orthodontic treatment.
- Participants who have been on antibiotics within the past 4 months.
- Participants who require prophylactic antibiotic coverage.
- Participants who have been on systemic or topical non-steroidal anti-inflammatory drugs for the past 4 months.
- Participants who are pregnant or intended to and lactating mother.
- Participants who have heart valve replacement and have known intolerance or allergy to mouth rinses.
- Participants who have any systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anti-plaque Effect of a Mouthwash Composed of Salvadora Persica L. and Green Tea: a 4days Randomized Controlled Crossover Clinical Trial
Periodontal diseases and caries are essentially initiated and progressed by accumulation of dental plaque. Thus, daily effective plaque control is valuable as a preventive measure and maintaining oral health. Mechanical plaque control is important but has limitations; therefore, an adjunctive chemical plaque control such as mouthwash is helpful. Various medicinal plant-derived galenicals might be used as safe and stable alternatives to synthetic mouthwashes. For example, a combination of Salvadora persica L. (Sp) root sticks and green tea (Gt) aqueous extract has been found to reduce plaque accumulation over 24 hours. Moreover, these extracts were reported to have anti-microbial activity against many oral bacteria. 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 for 4 days duration.
Read the detailed description
Dental plaque is the soft mass formed on oral surfaces including tooth surfaces. It composed of many species of which are commensal and other are pathogenic. The buildup of dental plaque starts by adhesion of floating bacteria, primary colonizers, in saliva onto oral surfaces such as tooth surfaces. Consequently, after adhesion, these primary bacteria provide adhesion sites for secondary plaque colonizers and the plaque buildup continues to achieve a mature dental plaque.
The mature dental plaque initiates host immune response by its bacterial content or its toxins in the adjacent gingival tissues. Periodontal health is assumed to be in a state of balance when the host immune response resolves the bacterial challenges. In other scenario, the host immune response fails to overcome invader bacteria or their toxins leading to chronicity of aberrant immune responses. Thus, periodontal diseases and caries may be developed due to imbalance between dental plaque accumulation and host defense. For that reason, dental plaque control is essential as preventive measure for good oral health.
Mechanical plaque control including tooth brushing and interdental aids is essential for preserving oral health. However, efficient mechanical control is time consuming and needs high manual dexterity and compliance. Therefore, chemical plaque control such as mouthwashes might be useful as adjunctive to mechanical control. Chlorohexidine mouthwash is the best-known mouthwash serving that purpose despite its side effects including tooth discoloration and bitter taste.
Salvadora persica L. (Sp) root sticks and green tea (Gt), leafs of Camellia sinensis, aqueous extracts were reported to exert anti-microbial activity against many oral bacteria. A combination (Co.) of Gt aqueous extract and Sp aqueous extract at a specific concentration (patented, IP 2015704777) was found to exhibit significant synergistic anti-bacterial and anti-adherence efficacy against primary plaque colonizers in vitro. This Co. as a mouthwash was reported to significantly reduce plaque accumulation comparing to chlorhexidine in vivo for a period of 24 hours (NCT02624336 in December 3, 2015).
- Conditions
- Periodontal Diseases
- Being tested
- Co., Kin, Distilled water
- Keywords
- Dental plaque,, Tea, Salvadora, Mouthwash, Clinical trial
- Medical subject headings
- Periodontal Diseases, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co.Other
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: Other: Co. |
| 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.
Mean amount plaque between different comparators
Mean amount plaque between different comparators as anti-plaque agent following 24 hrs plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.
Measured: Time Frame: 24 hours
Mean amount plaque between different comparators
Mean amount plaque between different comparators as anti-plaque agent following 4 days plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.
Measured: Time Frame: 4 days
Secondary outcomes (3)
Mean bacterial load in saliva
Mean bacterial load in saliva at 2 hours after rinsing with different comparators using quantitative polymerase chain reaction (qPCR).
Measured: 2 hours
Mean relative changes in gingival crevicular fluid flow rate
Mean relative changes in gingival crevicular fluid flow rate after rinsing with different comparators from baseline at 4 days.
Measured: 4 days
Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid
Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid after rinsing with different comparators from baseline at 4 days.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start10 Jan 2019
- Primary completion31 Mar 2019
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayder Raad Abdulbaqi, University of Baghdad
- Investigators
- Rasha S Abbood, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790904
- Sponsor's protocol ID
- 011618
- Status last verified
- May 2019
- First submitted
- 28 Dec 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- 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 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anti-plaque Effect of a Mouthwash Composed of Salvadora Persica L. and Green Tea: a 4days Randomized Controlled Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT03790904
- Acronym / sponsor ID
- 011618
- Conditions
- Periodontal Diseases
- Keywords
- Dental plaque,, Tea, Salvadora, Mouthwash, Clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 2 Jan 2019 (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.
Periodontal diseases and caries are essentially initiated and progressed by accumulation of dental plaque. Thus, daily effective plaque control is valuable as a preventive measure and maintaining oral health. Mechanical plaque control is important but has limitations; therefore, an adjunctive chemical plaque control such as mouthwash is helpful. Various medicinal plant-derived galenicals might be used as safe and stable alternatives to synthetic mouthwashes. For example, a combination of Salvadora persica L. (Sp) root sticks and green tea (Gt) aqueous extract has been found to reduce plaque accumulation over 24 hours. Moreover, these extracts were reported to have anti-microbial activity against many oral bacteria. 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 for 4 days duration.
Detailed description
Dental plaque is the soft mass formed on oral surfaces including tooth surfaces. It composed of many species of which are commensal and other are pathogenic. The buildup of dental plaque starts by adhesion of floating bacteria, primary colonizers, in saliva onto oral surfaces such as tooth surfaces. Consequently, after adhesion, these primary bacteria provide adhesion sites for secondary plaque colonizers and the plaque buildup continues to achieve a mature dental plaque.
The mature dental plaque initiates host immune response by its bacterial content or its toxins in the adjacent gingival tissues. Periodontal health is assumed to be in a state of balance when the host immune response resolves the bacterial challenges. In other scenario, the host immune response fails to overcome invader bacteria or their toxins leading to chronicity of aberrant immune responses. Thus, periodontal diseases and caries may be developed due to imbalance between dental plaque accumulation and host defense. For that reason, dental plaque control is essential as preventive measure for good oral health.
Mechanical plaque control including tooth brushing and interdental aids is essential for preserving oral health. However, efficient mechanical control is time consuming and needs high manual dexterity and compliance. Therefore, chemical plaque control such as mouthwashes might be useful as adjunctive to mechanical control. Chlorohexidine mouthwash is the best-known mouthwash serving that purpose despite its side effects including tooth discoloration and bitter taste.
Salvadora persica L. (Sp) root sticks and green tea (Gt), leafs of Camellia sinensis, aqueous extracts were reported to exert anti-microbial activity against many oral bacteria. A combination (Co.) of Gt aqueous extract and Sp aqueous extract at a specific concentration (patented, IP 2015704777) was found to exhibit significant synergistic anti-bacterial and anti-adherence efficacy against primary plaque colonizers in vitro. This Co. as a mouthwash was reported to significantly reduce plaque accumulation comparing to chlorhexidine in vivo for a period of 24 hours (NCT02624336 in December 3, 2015).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co. mouthwash | Active comparator | Other: Co.15ml 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
- 20 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants should be medically healthy.
- Participants should have more than 20 teeth.
Key exclusion criteria (8 listed)
- Participants who have active cavity caries and/or periodontal disease.
- Participants who have ongoing orthodontic treatment.
- Participants who have been on antibiotics within the past 4 months.
- Participants who require prophylactic antibiotic coverage.
- Participants who have been on systemic or topical non-steroidal anti-inflammatory drugs for the past 4 months.
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.15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min | Other | 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
Mean amount plaque between different comparators
Time frame: Time Frame: 24 hours
Mean amount plaque between different comparators as anti-plaque agent following 24 hrs plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.
Mean amount plaque between different comparators
Time frame: Time Frame: 4 days
Mean amount plaque between different comparators as anti-plaque agent following 4 days plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.
3 secondary outcomes
Mean bacterial load in saliva
Time frame: 2 hours
Mean relative changes in gingival crevicular fluid flow rate
Time frame: 4 days
Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid
Time frame: 4 days
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 14 May 2019.
- 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.
Rasha S Abbood 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 2 study testing Co., Kin and Distilled water in people with Periodontal Diseases, 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 2 inclusion and 8 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 14 May 2019. 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?
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?
Mean amount plaque between different comparators (time frame: Time Frame: 24 hours). The study lists 2 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 14 May 2019.