GingivitisPhase 1NCT01637948
Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse
A Phase 1 study testing Listerine mouthrinse and Chinese Medicine mouthrinse in people with Gingivitis, run by The University of Hong Kong at 1 site in China.
Trial summary
Traditional Chinese medicine (TCM) has been seen as the predominant way of treating disease in China over three thousand years. Certain TCM have scientifically proved to have anti-bacterial property. Patients having orthodontic treatment have higher risks of caries and gum diseases. Read more about this study
- Who is it for?
- Ages 13 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Listerine mouthrinse and Chinese Medicine mouthrinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Jan 2012
- Phase
- Phase 1
- 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 13 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects who have at less 20 permanent teeth
- Subjects who have a healthy systemic condition
- Subjects with age range 13-35.
- Subjects who are no-smoker;
- Subjects who haven't taken antibiotic medicine within a 2 week period prior
- Subjects who do not currently undergo any medication or will undergo any medication in next six months
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- Subjects who have not dental diseases that required ongoing treatment, which would confound the evaluation of result
- Subjects who are competent in giving consents
- Subjects who are not pregnant or lactating women
- Subjects who do not report teeth sensitivity
- Subjects who are not allergic to ethanol
- Subjects presented a minimum level of pre-existing gingivitis (MGI>1) but without peridontitis.(probing depth>4mm)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse In Improving Oral Health in Orthodontic Patients
Traditional Chinese medicine (TCM) has been seen as the predominant way of treating disease in China over three thousand years. Certain TCM have scientifically proved to have anti-bacterial property. Patients having orthodontic treatment have higher risks of caries and gum diseases. The purpose of this study was to determine whether the use of TCM Mouthrinses in addition to toothbrushing and flossing has an added benefit for orthodontic patients in maintaining proper oral health.
Read the detailed description
The aim of this study was to investigate the effects of a Traditional Chinese medicine (TCM) mouthrinse on gingival health and microbial profiles in orthodontic patients. This six-month randomized, single-blinded, parallel controlled clinical trial consists of 90 patients with fixed appliance treatment. The subjects were allocated to (1) negative-control group: oral hygiene instruction (OHI) alone; (2) positive-control group: OHI plus an EO mouthrinse (Listerine®)(3) test group: OHI plus the TCM mouthrinse (5% Fructus mume extract). Clinical examinations included Plaque Index (PI), Bleeding Index (BI) and Modified Gingival Index (MGI). Salivary microbial quantifications included total aerobic and anaerobic bacteria, Streptococci and Lactobacilli counts. Clinical and microbiological examinations were conducted at baseline, 3 and 6 months (T1, T2 and T3).
- Conditions
- Gingivitis
- Being tested
- Listerine mouthrinse, Chinese Medicine mouthrinse
- Keywords
- Chinese medicine, gingivitis, cytokine, microbial
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listerine mouthrinseDrug
Also called essential oils mouthrinse
For six months
Chinese Medicine mouthrinseDrug
Also called 5% Fructus mume and 2% soudium bicarbonate
six months
| Study group | Role | What they receive |
|---|---|---|
| Listerine | Active comparator | essential oil mouthrinse Receives: Drug: Listerine mouthrinse |
| Negative control | No intervention | without intervention |
| Chinese medicine mouthrinse | Experimental | 5% Fructus Mume extract and 2% sodium bicarbonate Receives: Drug: Chinese Medicine mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index
Modified gingival index
Measured: 6 months
Plaque index
plaque index
Measured: 6 months
gingival bleeding index
gingival bleeding index
Measured: 6 months
Secondary outcomes (3)
Salivary cytokines
Salivary inflammatory cytokines (IL-1β and MIF) levels were detected by ELISA assay.
Measured: 6 months
Adverse Events
the number of participants with side effects or adverse events were recorded throughout the whole study time.
Measured: 6 months
Salivary bacteria counts
Salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionJan 2012
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 The University of Hong KongThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Wing Kit, Ricky, The University of Hong Kong
- Investigators
- Ricky Wong, PhD, Principal investigator, Faculty of Dentistry, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637948
- Sponsor's protocol ID
- HKCTR-1145
- Status last verified
- Jul 2012
- First submitted
- 3 Jan 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse In Improving Oral Health in Orthodontic Patients
- ClinicalTrials.gov ID
- NCT01637948
- Acronym / sponsor ID
- HKCTR-1145
- Conditions
- Gingivitis
- Keywords
- Chinese medicine, gingivitis, cytokine, microbial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Jul 2012 (estimated)
- 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.
Traditional Chinese medicine (TCM) has been seen as the predominant way of treating disease in China over three thousand years. Certain TCM have scientifically proved to have anti-bacterial property. Patients having orthodontic treatment have higher risks of caries and gum diseases. The purpose of this study was to determine whether the use of TCM Mouthrinses in addition to toothbrushing and flossing has an added benefit for orthodontic patients in maintaining proper oral health.
Detailed description
The aim of this study was to investigate the effects of a Traditional Chinese medicine (TCM) mouthrinse on gingival health and microbial profiles in orthodontic patients. This six-month randomized, single-blinded, parallel controlled clinical trial consists of 90 patients with fixed appliance treatment. The subjects were allocated to (1) negative-control group: oral hygiene instruction (OHI) alone; (2) positive-control group: OHI plus an EO mouthrinse (Listerine®)(3) test group: OHI plus the TCM mouthrinse (5% Fructus mume extract). Clinical examinations included Plaque Index (PI), Bleeding Index (BI) and Modified Gingival Index (MGI). Salivary microbial quantifications included total aerobic and anaerobic bacteria, Streptococci and Lactobacilli counts. Clinical and microbiological examinations were conducted at baseline, 3 and 6 months (T1, T2 and T3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Listerine | Active comparator | Drug: Listerine mouthrinseessential oil mouthrinse |
| Negative control | No intervention | –without intervention |
| Chinese medicine mouthrinse | Experimental | Drug: Chinese Medicine mouthrinse5% Fructus Mume extract and 2% sodium bicarbonate |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Subjects who have at less 20 permanent teeth
- Subjects who have a healthy systemic condition
- Subjects with age range 13-35.
- Subjects who are no-smoker;
- Subjects who haven't taken antibiotic medicine within a 2 week period prior
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Listerine mouthrinseAlso: essential oils mouthrinseFor six months | Drug | Listerine |
| Chinese Medicine mouthrinseAlso: 5% Fructus mume and 2% soudium bicarbonatesix months | Drug | Chinese medicine mouthrinse |
Primary outcome
Gingival index
Time frame: 6 months
Modified gingival index
Plaque index
Time frame: 6 months
plaque index
gingival bleeding index
Time frame: 6 months
gingival bleeding index
3 secondary outcomes
Salivary cytokines
Time frame: 6 months
Adverse Events
Time frame: 6 months
Salivary bacteria counts
Time frame: 6 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 11 Jul 2012.
Related trials for Gingivitis
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Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
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Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
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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.
Ricky Wong, PhD principal investigator
Faculty of Dentistry, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Listerine mouthrinse and Chinese Medicine mouthrinse in people with Gingivitis, run by The University of Hong Kong at 1 site in China.
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 12 inclusion and 0 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 11 Jul 2012. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Gingival index (time frame: 6 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 11 Jul 2012.