Dental CariesNCT04390256
Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers
A study testing Clove water extract, Carbopol and Carboxymethyle cellulose in people with Dental Caries, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate: 1. The remineralization potential of natural agents (egg shell powder and clove extract) versus bioadhesive polymers (carbopol and carboxymethyl cellulose) with or without PH cycling using microhardness test. 2. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Clove water extract, Carbopol and Carboxymethyle cellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 10 May 2020
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Criteria related to patient:
- Age's eligible for trial was 18- 30 years.
- Patient able to read and sign the informed consent form.
- Cooperative patient who are willing to participate and able to continue the schedule time of wok keep good oral hygiene throughout the study.
- Healthy volunteers.
- Patient with moderate and high caries index. 2. Criteria related to tooth:
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- Patient with at least 2 white lesions (WSL) detected clinically on the buccal surface of permanent anterior teeth, one on each side. WSL selected either due to caries or orthodontic treatment (just following deboning).
- Teeth with score1, 2, 3 according to ICDAS II.
- Absence of preoperative pain, no mobility \& tenderness on percussion.
- Radiographically, the pre-operative inclusion criteria were absence of internal or external resorption, no periapical radiolucencies and no widening of periodontal ligament space..
Who cannot join
- 1. Criteria related to patient:
- Patient with Rampant uncontrolled caries.
- Patient with compromised medical history.
- Pregnant or breast feeding females.
- Heavy smoker.
- Patient who currently received extensive fluoride regiments for treatment of WSL.
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- Patients who planned to move within 3 months of enrollment.
- Patient with evidence of xerostomia. 2. Criteria related to tooth:
- Teeth with score 4, 5 according to ICDAS II.
- Teeth with periapical pathology, internal or external resorption or exhibiting any symptoms of pulp pathology.
- Teeth with questionable vitality or have root canal therapy.
- Teeth have been pulp capped.
- Teeth with periodontal pocket and bleeding on probing.
- Cracked teeth.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to evaluate:
- The remineralization potential of natural agents (egg shell powder and clove extract) versus bioadhesive polymers (carbopol and carboxymethyl cellulose) with or without PH cycling using microhardness test.
- The clinical efficacy of all agents in patients with early carious lesions.
- Conditions
- Dental Caries
- Being tested
- Clove water extract, Carbopol, Carboxymethyle cellulose
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clove water extractOther
natural product
CarbopolOther
Bioadhesive polymer
Carboxymethyle celluloseOther
Bioadhesive polymer
| Study group | Role | What they receive |
|---|---|---|
| Egg shell powder nanoparticles | Active comparator | Not described Receives: Other: Clove water extract; Other: Carbopol; Other: Carboxymethyle cellulose |
| Clove water extract | Experimental | Not described Receives: Other: Clove water extract; Other: Carbopol; Other: Carboxymethyle cellulose |
| Carbopol | Experimental | Not described Receives: Other: Clove water extract; Other: Carbopol; Other: Carboxymethyle cellulose |
| Carboxymethyle cellulose | Experimental | Not described Receives: Other: Clove water extract; Other: Carbopol; Other: Carboxymethyle cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization of enamel
Remineralization of enamel using Vista scan
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Jun 2017
- Primary completion10 Jan 2020
- Study completion10 May 2020
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 Al-Azhar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390256
- Sponsor's protocol ID
- REC17-030
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers
- ClinicalTrials.gov ID
- NCT04390256
- Acronym / sponsor ID
- REC17-030
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 15 May 2020 (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 study will be conducted to evaluate:
- The remineralization potential of natural agents (egg shell powder and clove extract) versus bioadhesive polymers (carbopol and carboxymethyl cellulose) with or without PH cycling using microhardness test.
- The clinical efficacy of all agents in patients with early carious lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Egg shell powder nanoparticles | Active comparator | Other: Clove water extract, Other: Carbopol, Other: Carboxymethyle cellulose |
| Clove water extract | Experimental | Other: Clove water extract, Other: Carbopol, Other: Carboxymethyle cellulose |
| Carbopol | Experimental | Other: Clove water extract, Other: Carbopol, Other: Carboxymethyle cellulose |
| Carboxymethyle cellulose | Experimental | Other: Clove water extract, Other: Carbopol, Other: Carboxymethyle cellulose |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 1. Criteria related to patient:
Key exclusion criteria (14 listed)
- 1. Criteria related to patient:
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 |
|---|---|---|
| Clove water extractnatural product | Other | Carbopol, Carboxymethyle cellulose, Clove water extract, Egg shell powder nanoparticles |
| CarbopolBioadhesive polymer | Other | Carbopol, Carboxymethyle cellulose, Clove water extract, Egg shell powder nanoparticles |
| Carboxymethyle celluloseBioadhesive polymer | Other | Carbopol, Carboxymethyle cellulose, Clove water extract, Egg shell powder nanoparticles |
Primary outcome
Remineralization of enamel
Time frame: 3 months
Remineralization of enamel using Vista scan
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 15 May 2020.
- 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.
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 study testing Clove water extract, Carbopol and Carboxymethyle cellulose in people with Dental Caries, run by Al-Azhar 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 10 inclusion and 14 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 15 May 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.
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?
Remineralization of enamel (time frame: 3 months). 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 15 May 2020.