Dental CariesNCT06847984
Antimicrobial Effect of Curcumin Versus Chlorohexidine on Oral Microbiome
A study testing Curcumin and Chlorohexidine in people with Dental Caries and Dental Plaque Index, run by Cairo University at 1 site in Egypt.
Trial summary
Dental caries, one of the world's most common infectious diseases, is a biofilm-mediated, sugar-driven, dynamic disease. It has an impact on physical, mental, and social health and is extremely costly to society. It is a complex disease with microbiological, behavioral, genetic, and environmental components. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Dental Caries, Dental Plaque Index, Oral Microbiome
- What is being tested?
- Curcumin and Chlorohexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provide informed consent.
- Patients accept the one-year follow-up period.
- Cooperative patients.
- The study recruited volunteers of both genders
- Age from 21 to 45 years
- Patients classified at high risk of caries
Who cannot join
- Patients undergoing orthodontic treatment.
- Periodontal compromised patients.
- Smokers.
- Pregnant women.
- Patients with physical or mental disability
- Patient with removable prosthesis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University
Cairo, Cairo Governorate, 4240310
Alaa F Abdelsalam, PhD holder, +201010890484, alaa.fathi@dentistry.cu.edu.eg
Salma B Basyouni, PHD candidate
About this study
Official title: Antimicrobial Effect of Curcumin on Oral Microbiome Versus Chlorohexidine in High Caries Risk Individuals
Dental caries, one of the world's most common infectious diseases, is a biofilm-mediated, sugar-driven, dynamic disease. It has an impact on physical, mental, and social health and is extremely costly to society. It is a complex disease with microbiological, behavioral, genetic, and environmental components. Recently, it has been demonstrated in the literature that the development of dental caries is strongly related with the microbiota in the oral cavity. So, a detailed understanding of caries microbiology is needed.
Oral microbiome, oral microbiota or oral microflora refers to the microorganisms found in the human oral cavity that was first identified by the Dutchman Antony van Leeuwenhoek using a microscope constructed by him. In 1674, he observed his own dental plaque and reported "little living animalcules prettily moving".
Read more
Human microbiome consists of a core microbiome which is common to all the individuals and a variable microbiome that is unique to individuals depending on the lifestyle and physiological differences. Dental caries, as a process determined by lifestyle, may be subject to activation in each period of human life if hygiene and diet are neglected even for a period as short as a few weeks.
Previous hypotheses suggest that Streptococcus mutans is the primary pathogen in the development of dental caries in both children and adults. However, recently published papers provide a partially different perspective on the role of bacteria in the caries process, known as the "extended caries ecological hypothesis," which attempts to demonstrate that the role of S. mutans in the initiation of dental caries may not be as dominant as previously assumed, but there is agreement that they have the highest cariogenic potential.
It is now believed that the disease is caused by microorganisms belonging to the natural flora of the oral cavity: the oral microbiome. There is a dynamic equilibrium between microorganisms as well as between the micro flora and the 7 host, and the disease develops as a result of a microbiological imbalance within the biofilm.
Therefore, a better understanding of processes of oral biofilm formation and function is necessary to the development of novel, successful, rational approach for antimicrobial strategies and caries prevention and treatment.
Primary caries can be prevented, stopped and treated by regular plaque removal and remineralization mechanisms. Fluorides play a central role in the prevention of dental caries and are being used extensively and therapeutically for the inactivation of incipient carious lesions. However, regarding the high cost of dental clinic setting and difficult access to the oral health care service that is not well-covered in certain countries; the treatment strategy should move towards the preventive, simple, accessible, less costly methods.
The frequent use and abuse of the currently used therapeutic agents has led to the evolution of resistant strains of common pathogens as well as increased incidence of adverse effects associated with their usage. Therefore, natural phytochemicals extracted from plants used as traditional medicines are therefore seen as a good alternative source.
Pharmaceutical plants have been used throughout human history to treat a variety of diseases. According to the World Health Organization, almost 80% of the world's population relies on traditional medicinal plants for primary health care. In dentistry, there is a growing need to develop natural materials with anti-caries qualities.
Curcumin (CUR), a dietary natural product extracted from the root of turmeric (the major constituent of Curcuma longa L. or turmeric), which is widely used as a flavoring and coloring agent has many pharmacological activities including anti-inflammatory and antitumor properties. In addition, CUR has been shown to have anti-bacterial, whitening, and antioxidative activities. Various studies on widespread Polyphenolic compounds suggest that curcumin inhibits the bacterial effect by reducing the production of acid and stopping the adherence of bacteria to the tooth surface. Song et al. found that curcumin could significantly inhibit the adhesiveness of S. mutans by its effects on collagen and fibronectin. The antibacterial action of curcumin involves the disruption of the bacterial membrane, inhibition of the production of bacterial virulence factors and biofilm formation, and the induction of oxidative stress. These characteristics also contribute to explain how curcumin acts a broad-spectrum antibacterial adjuvant. So, the aim of the following interventional study is to evaluate the effect of curcumin on oral microbiome obtained from salivary samples of high caries risk patients in vitro and assess the antiplaque and anticariogenic effect of curcumin mouth wash in high caries risk patients in a randomized controlled clinical trial compared to chlorohexidine mouth wash.
- Conditions
- Dental Caries, Dental Plaque Index, Oral Microbiome
- Being tested
- Curcumin, Chlorohexidine
- Keywords
- oral microbiome, curcumin, chlorohexidine, antimicrobial
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Participants were instructed to rinse with 10 mL of mouthwash for
1 minute, once daily for 1 week of each month. This regimen will be repeated monthly for a period of 1 year.
ChlorohexidineOther
Participants were instructed to rinse with 10 mL of mouthwash for 1 minute, once daily for 1 week of each month. This regimen will be repeated monthly for a period of 1 year
| Study group | Role | What they receive |
|---|---|---|
| chlorohexidine | Active comparator | Participants were instructed to rinse with 10 mL of mouthwash for
1 minute, once daily for 1 week of each month. This regimen was repeated monthly for a period of 1 year Receives: Other: Chlorohexidine |
| curcumin | Experimental | Participants were instructed to rinse with 10 mL of mouthwash for
1 minute, once daily for 1 week of each month. This regimen was repeated monthly for a period of 1 year Receives: Dietary Supplement: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries incidence
caries incidence will be checked using DMF (Decayed, Missing or Filled Surfaces,)
Measured: Baseline, 7, 30 days, 3 months, 1 year
Secondary outcomes (1)
Plaque
plaque will be checked using plaque index. minimal value (0): absence of microbial plaque. maximum value (3): large amount of plaque in sulcus or pocket along the free gingival margin Higher scores mean a worse outcome.
Measured: Baseline, 7, 30 days, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Basyouni, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847984
- Sponsor's protocol ID
- Curc-Chlorohexidine
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still undecided,
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Effect of Curcumin on Oral Microbiome Versus Chlorohexidine in High Caries Risk Individuals
- ClinicalTrials.gov ID
- NCT06847984
- Acronym / sponsor ID
- Curc-Chlorohexidine
- Conditions
- Dental Caries, Dental Plaque Index, Oral Microbiome
- Keywords
- oral microbiome, curcumin, chlorohexidine, antimicrobial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 26 Feb 2025 (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.
Dental caries, one of the world's most common infectious diseases, is a biofilm-mediated, sugar-driven, dynamic disease. It has an impact on physical, mental, and social health and is extremely costly to society. It is a complex disease with microbiological, behavioral, genetic, and environmental components. Recently, it has been demonstrated in the literature that the development of dental caries is strongly related with the microbiota in the oral cavity. So, a detailed understanding of caries microbiology is needed.
Oral microbiome, oral microbiota or oral microflora refers to the microorganisms found in the human oral cavity that was first identified by the Dutchman Antony van Leeuwenhoek using a microscope constructed by him. In 1674, he observed his own dental plaque and reported "little living animalcules prettily moving".
Human microbiome consists of a core microbiome which is common to all the individuals and a variable microbiome that is unique to individuals depending on the lifestyle and physiological differences. Dental caries, as a process determined by lifestyle, may be subject to activation in each period of human life if hygiene and diet are neglected even for a period as short as a few weeks.
Previous hypotheses suggest that Streptococcus mutans is the primary pathogen in the development of dental caries in both children and adults. However, recently published papers provide a partially different perspective on the role of bacteria in the caries process, known as the "extended caries ecological hypothesis," which attempts to demonstrate that the role of S. mutans in the initiation of dental caries may not be as dominant as previously assumed, but there is agreement that they have the highest cariogenic potential.
It is now believed that the disease is caused by microorganisms belonging to the natural flora of the oral cavity: the oral microbiome. There is a dynamic equilibrium between microorganisms as well as between the micro flora and the 7 host, and the disease develops as a result of a microbiological imbalance within the biofilm.
Therefore, a better understanding of processes of oral biofilm formation and function is necessary to the development of novel, successful, rational approach for antimicrobial strategies and caries prevention and treatment.
Primary caries can be prevented, stopped and treated by regular plaque removal and remineralization mechanisms. Fluorides play a central role in the prevention of dental caries and are being used extensively and therapeutically for the inactivation of incipient carious lesions. However, regarding the high cost of dental clinic setting and difficult access to the oral health care service that is not well-covered in certain countries; the treatment strategy should move towards the preventive, simple, accessible, less costly methods.
The frequent use and abuse of the currently used therapeutic agents has led to the evolution of resistant strains of common pathogens as well as increased incidence of adverse effects associated with their usage. Therefore, natural phytochemicals extracted from plants used as traditional medicines are therefore seen as a good alternative source.
Pharmaceutical plants have been used throughout human history to treat a variety of diseases. According to the World Health Organization, almost 80% of the world's population relies on traditional medicinal plants for primary health care. In dentistry, there is a growing need to develop natural materials with anti-caries qualities.
Curcumin (CUR), a dietary natural product extracted from the root of turmeric (the major constituent of Curcuma longa L. or turmeric), which is widely used as a flavoring and coloring agent has many pharmacological activities including anti-inflammatory and antitumor properties. In addition, CUR has been shown to have anti-bacterial, whitening, and antioxidative activities. Various studies on widespread Polyphenolic compounds suggest that curcumin inhibits the bacterial effect by reducing the production of acid and stopping the adherence of bacteria to the tooth surface. Song et al. found that curcumin could significantly inhibit the adhesiveness of S. mutans by its effects on collagen and fibronectin. The antibacterial action of curcumin involves the disruption of the bacterial membrane, inhibition of the production of bacterial virulence factors and biofilm formation, and the induction of oxidative stress. These characteristics also contribute to explain how curcumin acts a broad-spectrum antibacterial adjuvant. So, the aim of the following interventional study is to evaluate the effect of curcumin on oral microbiome obtained from salivary samples of high caries risk patients in vitro and assess the antiplaque and anticariogenic effect of curcumin mouth wash in high caries risk patients in a randomized controlled clinical trial compared to chlorohexidine mouth wash.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorohexidine | Active comparator | Other: ChlorohexidineParticipants were instructed to rinse with 10 mL of mouthwash for 1 minute, once daily for 1 week of each month. This regimen was repeated monthly for a period of 1 year |
| curcumin | Experimental | Dietary Supplement: CurcuminParticipants were instructed to rinse with 10 mL of mouthwash for 1 minute, once daily for 1 week of each month. This regimen was repeated monthly for a period of 1 year |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provide informed consent.
- Patients accept the one-year follow-up period.
- Cooperative patients.
- The study recruited volunteers of both genders
- Age from 21 to 45 years
Key exclusion criteria (6 listed)
- Patients undergoing orthodontic treatment.
- Periodontal compromised patients.
- Smokers.
- Pregnant women.
- Patients with physical or mental disability
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 |
|---|---|---|
| CurcuminParticipants were instructed to rinse with 10 mL of mouthwash for 1 minute, once daily for 1 week of each month. This regimen will be repeated monthly for a period of 1 year. | Dietary supplement | curcumin |
| ChlorohexidineParticipants were instructed to rinse with 10 mL of mouthwash for 1 minute, once daily for 1 week of each month. This regimen will be repeated monthly for a period of 1 year | Other | chlorohexidine |
Primary outcome
Caries incidence
Time frame: Baseline, 7, 30 days, 3 months, 1 year
caries incidence will be checked using DMF (Decayed, Missing or Filled Surfaces,)
1 secondary outcome
Plaque
Time frame: Baseline, 7, 30 days, 3 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Caries Preventive and Antibacterial Effects of Two Natural Mouthwashes vs Chlorhexidine in High Caries-risk Patients: A Randomized Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. still 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin and Chlorohexidine in people with Dental Caries and Dental Plaque Index, 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 6 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: opening soon, as of the sponsor's last update on 26 Feb 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma Basyouni Ibrahim, Phd (00201143022117, Salma.basyouni@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries incidence (time frame: Baseline, 7, 30 days, 3 months, 1 year). 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 26 Feb 2025.