High Caries Risk PatientsPhase 2/3NCT03684993
Caries Prevention and Side Effects of Gum Arabic and Licorice Extracts Versus Chlorhexidine in High Caries Risk Patients
A Phase 2/3 study testing Arabic, Gum, Licorice Root and Chlorhexidine in people with High Caries Risk Patients and Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This trial is to test the caries prevention effect of Arabic gum and Licorice root extracts compared to Chlorhexidine in high caries risk patients. The antimicrobial efficacy and oral side effects from using these mouthwashes will also be tested. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- High Caries Risk Patients, Caries, Antimicrobial Effect
- What is being tested?
- Arabic, Gum, Licorice Root and Chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2019to 15 Jan 2020
- Phase
- Phase 2/3
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- High caries risk patients according to CAMBRA caries risk assessment tool
- Baseline of at least 2-3 active non-cavitated or cavitated carious lesionssz
- Baseline salivary Mutans streptococci count ≥ 106 CFU/ml
- Baseline salivary Lactobacilli count ≥ 104 CFU/ml
- Baseline DMF index of at least 3-5
- Cooperative patients approving to participate in the study
Who cannot join
- Any systemic conditions, severe medical complications
- Significant past or current medical condition that may affect oral health or oral flora
- Current medications (may affect the oral flora or salivary flow)
- Allergy to any of the ingredients of the study products
- Use of any antibiotics within the past 3 months
- Use of any mouth rinses within the past 3 months
Show all 16Show fewer
- Current periodontitis (sites of probing pocket depth ≥ 5 mm)
- Evidence of parafunctional habits
- Dysfunction of temporomandibular joint
- Presence of developmental dental anomalies
- Presence of orthodontic appliance or removable prosthesis
- Pregnancy
- Xerostomia
- Heavy smoking
- Drug or alcohol addiction, or conditions that may decrease adhering to study protocol
- Lack of compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gum Arabic (Acacia Gum) and Licorice (Glycyrrhiza Glabra) Mouthwashes Compared to Chlorhexidine Mouthwash on Caries Prevention and the Prevalence of Oral Side Effects in High Caries Risk Patients: A Randomized Controlled Clinical Trial
This trial is to test the caries prevention effect of Arabic gum and Licorice root extracts compared to Chlorhexidine in high caries risk patients. The antimicrobial efficacy and oral side effects from using these mouthwashes will also be tested.
Read the detailed description
To evaluate the effect of Arabic gum (Acacia gum) and Licorice (Glycyrrhiza Glabra) mouthwashes in comparison to Chlorhexidine mouthwash on reducing caries incidence (development of new caries lesions), antimicrobial efficacy and the prevalence of oral side effects (adverse events) in high caries risk patients.
P: Population with high caries risk patients I1: Arabic Gum mouthwash I2: Licorice mouthwash C: Chlorhexidine mouthwash O1: (Primary outcome) incidence of new caries lesions O2: (secondary outcome) antimicrobial efficacy O3: oral side effects (adverse events) from mouthwash use
- Conditions
- High Caries Risk Patients, Caries, Antimicrobial Effect, Side Effect
- Being tested
- Arabic, Gum, Licorice Root, Chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabic, GumDrug
Also called acacia gum
natural gum of acacia tree: Antimicrobial, anti-inflammatory medicinal plant used as a traditional oral hygiene substance (anticariogenic). It is used in treating sore throats, colds, bronchitis, toothache, gingival bleeding and mouth ulcers.
Licorice RootDrug
Also called Glycyrrhiza Glabra
natural licorice, herbal plant to relieve coughs, sore throats, and gastric inflammation. flavouring and sweetening agent. it's anti-caries, soothing anti-inflammatory and anticancer properties benefit against oral diseases and dental caries
ChlorhexidineDrug
Also called Chlorhexidine gluconate or Chlorhexidine HCL
chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard
| Study group | Role | What they receive |
|---|---|---|
| Arabic gum extract | Experimental | natural product Arabic gum (acacia gum) prepared as a mouthwash Receives: Drug: Arabic, Gum |
| Licorice root extract | Experimental | natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash Receives: Drug: Licorice Root |
| Chlorhexidine | Active comparator | chemical agent Chlorhexidine as a mouthwash Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries incidence - DMF index - visual and tactile clinical examination for caries detection according to the ICDAS critera
development of new caries lesions. Clinical examination during study time to Measure DMF scoring index: any changes in number of decayed, missing and filled surfaces due to caries from baseline. Done according to International Caries Detection and Assessment System (ICDAS II criteria)
Measured: 1 year (detected after 3, 6, 9 and 12 months)
Secondary outcomes (2)
Antimicrobial efficacy - Incubating agar plates - Colony forming units (CFU/mL)
Antimicrobial effect against streptococcus mutans and lactocbacilli: saliva samples collected and total bacterial count measured after agar plates incubating, expressed in colony forming units
Measured: 1 year (evaluated after 3, 6, 9 and 12 months)
Side (Adverse) effect - subjective: Reporting Questionnaire - Binary outcome (yes/no)
side effects from long term use of mouthwash
Measured: 1 year (recorded after each month of mouthwash use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start10 Dec 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for High Caries Risk PatientsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Kamal Eldin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684993
- Sponsor's protocol ID
- arabic gum licorice CHX
- Status last verified
- Feb 2020
- First submitted
- 24 Sep 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta D, Gupta RK. Investigation of antibacterial efficacy of Acacia nilotica against salivary mutans streptococci: a randomized control trial. Gen Dent. 2015 Jan-Feb;63(1):23-7.
PubMed 25574715Hu CH, He J, Eckert R, Wu XY, Li LN, Tian Y, Lux R, Shuffer JA, Gelman F, Mentes J, Spackman S, Bauer J, Anderson MH, Shi WY. Development and evaluation of a safe and effective sugar-free herbal lollipop that kills cavity-causing bacteria. Int J Oral Sci. 2011 Jan;3(1):13-20. doi: 10.4248/IJOS11005.
PubMed 21449211Chandra Shekar BR, Nagarajappa R, Singh R, Thaku R. Antimicrobial efficacy of the combinations of Acacia nilotica, Murraya koenigii L. sprengel, Eucalyptus hybrid and Psidium guajava on primary plaque colonizers. J Basic Clin Pharm. 2014 Sep;5(4):115-9. doi: 10.4103/0976-0105.141954.
PubMed 25316992Almaz ME, Sonmez IS, Okte Z, Oba AA. Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. Clin Oral Investig. 2017 Apr;21(3):839-845. doi: 10.1007/s00784-016-1827-y. Epub 2016 Apr 30.
PubMed 27129589Jain E, Pandey RK, Khanna R. Liquorice root extracts as potent cariostatic agents in pediatric practice. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):146-52. doi: 10.4103/0970-4388.117964.
PubMed 24021323
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gum Arabic (Acacia Gum) and Licorice (Glycyrrhiza Glabra) Mouthwashes Compared to Chlorhexidine Mouthwash on Caries Prevention and the Prevalence of Oral Side Effects in High Caries Risk Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03684993
- Acronym / sponsor ID
- arabic gum licorice CHX
- Conditions
- High Caries Risk Patients, Caries, Antimicrobial Effect, Side Effect
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 26 Sep 2018 (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.
This trial is to test the caries prevention effect of Arabic gum and Licorice root extracts compared to Chlorhexidine in high caries risk patients. The antimicrobial efficacy and oral side effects from using these mouthwashes will also be tested.
Detailed description
To evaluate the effect of Arabic gum (Acacia gum) and Licorice (Glycyrrhiza Glabra) mouthwashes in comparison to Chlorhexidine mouthwash on reducing caries incidence (development of new caries lesions), antimicrobial efficacy and the prevalence of oral side effects (adverse events) in high caries risk patients.
P: Population with high caries risk patients I1: Arabic Gum mouthwash I2: Licorice mouthwash C: Chlorhexidine mouthwash O1: (Primary outcome) incidence of new caries lesions O2: (secondary outcome) antimicrobial efficacy O3: oral side effects (adverse events) from mouthwash use
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arabic gum extract | Experimental | Drug: Arabic, Gumnatural product Arabic gum (acacia gum) prepared as a mouthwash |
| Licorice root extract | Experimental | Drug: Licorice Rootnatural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash |
| Chlorhexidine | Active comparator | Drug: Chlorhexidinechemical agent Chlorhexidine as a mouthwash |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- High caries risk patients according to CAMBRA caries risk assessment tool
- Baseline of at least 2-3 active non-cavitated or cavitated carious lesionssz
- Baseline salivary Mutans streptococci count ≥ 106 CFU/ml
- Baseline salivary Lactobacilli count ≥ 104 CFU/ml
- Baseline DMF index of at least 3-5
Key exclusion criteria (16 listed)
- Any systemic conditions, severe medical complications
- Significant past or current medical condition that may affect oral health or oral flora
- Current medications (may affect the oral flora or salivary flow)
- Allergy to any of the ingredients of the study products
- Use of any antibiotics within the past 3 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 |
|---|---|---|
| Arabic, GumAlso: acacia gumnatural gum of acacia tree: Antimicrobial, anti-inflammatory medicinal plant used as a traditional oral hygiene substance (anticariogenic). It is used in treating sore throats, colds, bronchitis, toothache, gingival bleeding and mouth ulcers. | Drug | Arabic gum extract |
| Licorice RootAlso: Glycyrrhiza Glabranatural licorice, herbal plant to relieve coughs, sore throats, and gastric inflammation. flavouring and sweetening agent. it's anti-caries, soothing anti-inflammatory and anticancer properties benefit against oral diseases and dental caries | Drug | Licorice root extract |
| ChlorhexidineAlso: Chlorhexidine gluconate or Chlorhexidine HCLchemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard | Drug | Chlorhexidine |
Primary outcome
Caries incidence - DMF index - visual and tactile clinical examination for caries detection according to the ICDAS critera
Time frame: 1 year (detected after 3, 6, 9 and 12 months)
development of new caries lesions. Clinical examination during study time to Measure DMF scoring index: any changes in number of decayed, missing and filled surfaces due to caries from baseline. Done according to International Caries Detection and Assessment System (ICDAS II criteria)
2 secondary outcomes
Antimicrobial efficacy - Incubating agar plates - Colony forming units (CFU/mL)
Time frame: 1 year (evaluated after 3, 6, 9 and 12 months)
Side (Adverse) effect - subjective: Reporting Questionnaire - Binary outcome (yes/no)
Time frame: 1 year (recorded after each month of mouthwash use)
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 28 Feb 2020.
- Background: PubMed 25574715Gupta D, Gupta RK. Investigation of antibacterial efficacy of Acacia nilotica against salivary mutans streptococci: a randomized control trial. Gen Dent. 2015 Jan-Feb;63(1):23-7.
- Background: PubMed 21449211Hu CH, He J, Eckert R, Wu XY, Li LN, Tian Y, Lux R, Shuffer JA, Gelman F, Mentes J, Spackman S, Bauer J, Anderson MH, Shi WY. Development and evaluation of a safe and effective sugar-free herbal lollipop that kills cavity-causing bacteria. Int J Oral Sci. 2011 Jan;3(1):13-20. doi: 10.4248/IJOS11005.
- Background: PubMed 25316992Chandra Shekar BR, Nagarajappa R, Singh R, Thaku R. Antimicrobial efficacy of the combinations of Acacia nilotica, Murraya koenigii L. sprengel, Eucalyptus hybrid and Psidium guajava on primary plaque colonizers. J Basic Clin Pharm. 2014 Sep;5(4):115-9. doi: 10.4103/0976-0105.141954.
- Background: PubMed 27129589Almaz ME, Sonmez IS, Okte Z, Oba AA. Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. Clin Oral Investig. 2017 Apr;21(3):839-845. doi: 10.1007/s00784-016-1827-y. Epub 2016 Apr 30.
- Background: PubMed 24021323Jain E, Pandey RK, Khanna R. Liquorice root extracts as potent cariostatic agents in pediatric practice. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):146-52. doi: 10.4103/0970-4388.117964.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Arabic, Gum, Licorice Root and Chlorhexidine in people with High Caries Risk Patients and Caries, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 16 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 28 Feb 2020. 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 Egypt. 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 combined 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.
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?
Caries incidence - DMF index - visual and tactile clinical examination for caries detection according to the ICDAS critera (time frame: 1 year (detected after 3, 6, 9 and 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684993, which also lists 5 linked publications.
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 28 Feb 2020.