Deep CariesNCT05327049
Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions.
A study testing diode laser and Aloe Vera in people with Deep Caries, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The present study will be performed to evaluate: The remineralizing effect of Aloe Vera versus Diode laser on deep carious dentin after selective caries removal. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- diode laser and Aloe Vera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 11 Oct 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must have active deep carious lesion.
- clinical and radiographic examinations of carious lesions.
Who cannot join
- Teeth with pulpal involvement
- Teeth with abscess
- Teeth with pain or swelling
- Teeth with developmental disorders
- Teeth with adjacent soft tissue lesions
- patients with systemic illness will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions
The present study will be performed to evaluate:
The remineralizing effect of Aloe Vera versus Diode laser on deep carious dentin after selective caries removal.
Read the detailed description
This study was conducted on 45 teeth selected from patients according to inclusion and exclusion criteria. They were selected from the dental clinic in faculty of oral and dental medicine for girls, Al-Azhar University. The procedure was explained and written informed consent was obtained from each patient. The possible discomforts, risks, and benefits were fully explained to the patients. Ethical committee approval was obtained.
Protocol of caries removal was Applied Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin was excavated, leaving the leathery dentin layer.
Sample grouping:
The patients were randomly assigned into three main groups according to the material used (15 for each) which were assessed at different time intervals (B1) after three months,(B2) after six months.
A1: cavities will be sealed directly by temporary restorative material (conventional glass ionomer) without any treatment.
A2: cavities will be treated by Diode laser then sealed directly by temporary conventional glass ionomer.
A3: cavities will be treated with Aloe Vera then sealed directly by temporary conventional glass ionomer.
Evaluation of the remineralization effect of Each group will be assessed radiographically immediately at base line (B0), after three months (B1) and six months (B2) to evaluate the dentin remineralization.
- Conditions
- Deep Caries
- Being tested
- no intervention, diode laser, Aloe Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
treatment of deep carious lesions
diode laserDevice
laser light for cavity disinfection
Aloe VeraDietary supplement
herbal dietary supplement for treatment of deep carious lesions
| Study group | Role | What they receive |
|---|---|---|
| no intervention | Experimental | No Intervention: conventional selective caries removal without treatment After taking the first sample of dentin, the cavity will be restored Receives: Other: no intervention |
| diode laser treatment | Experimental | After selective caries removal the cavity was irradiated in contact mode with continuous wave of radiation through a 400µm flexible fiber that was inserted inside the cavity with a spiral continuous movement clockwise from the top to the floor and anti-clockwise in the reverse direction. Irradiation time was 15 seconds and repeated three times for 15 seconds interval with contact, pulsed mode and the output power was adjusted at 1.30 Watt. Receives: Device: diode laser |
| Aloe Vera treatment | Experimental | After selective caries removal the lesions were treated with aloe Vera paste which was prepared by mixing aloe Vera powder by distilled water until a thick paste is formed. the paste was applied to the prepared floor by condenser to cover the remaining carious lesion Receives: Dietary Supplement: Aloe Vera |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the remineralizing effect of aloe vera and diode laser on deep caries
remineralisation will be assessed by radiodensity using digital radiography
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 posted14 Apr 2022
- Study start1 Feb 2021
- Primary completion1 Oct 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayam mosad, Al-Azhar University
- Investigators
- Maha Niazy, professor, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327049
- Sponsor's protocol ID
- OPEN- 108-L
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions
- ClinicalTrials.gov ID
- NCT05327049
- Acronym / sponsor ID
- OPEN- 108-L
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 14 Apr 2022 (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.
The present study will be performed to evaluate:
The remineralizing effect of Aloe Vera versus Diode laser on deep carious dentin after selective caries removal.
Detailed description
This study was conducted on 45 teeth selected from patients according to inclusion and exclusion criteria. They were selected from the dental clinic in faculty of oral and dental medicine for girls, Al-Azhar University. The procedure was explained and written informed consent was obtained from each patient. The possible discomforts, risks, and benefits were fully explained to the patients. Ethical committee approval was obtained.
Protocol of caries removal was Applied Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin was excavated, leaving the leathery dentin layer.
Sample grouping:
The patients were randomly assigned into three main groups according to the material used (15 for each) which were assessed at different time intervals (B1) after three months,(B2) after six months.
A1: cavities will be sealed directly by temporary restorative material (conventional glass ionomer) without any treatment.
A2: cavities will be treated by Diode laser then sealed directly by temporary conventional glass ionomer.
A3: cavities will be treated with Aloe Vera then sealed directly by temporary conventional glass ionomer.
Evaluation of the remineralization effect of Each group will be assessed radiographically immediately at base line (B0), after three months (B1) and six months (B2) to evaluate the dentin remineralization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no intervention | Experimental | Other: no interventionNo Intervention: conventional selective caries removal without treatment After taking the first sample of dentin, the cavity will be restored |
| diode laser treatment | Experimental | Device: diode laserAfter selective caries removal the cavity was irradiated in contact mode with continuous wave of radiation through a 400µm flexible fiber that was inserted inside the cavity with a spiral continuous movement clockwise from the top to the floor and anti-clockwise in the reverse direction. Irradiation time was 15 seconds and repeated three times for 15 seconds interval with contact, pulsed mode and the output power was adjusted at 1.30 Watt. |
| Aloe Vera treatment | Experimental | Dietary Supplement: Aloe VeraAfter selective caries removal the lesions were treated with aloe Vera paste which was prepared by mixing aloe Vera powder by distilled water until a thick paste is formed. the paste was applied to the prepared floor by condenser to cover the remaining carious lesion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject must have active deep carious lesion.
- clinical and radiographic examinations of carious lesions.
Key exclusion criteria (6 listed)
- Teeth with pulpal involvement
- Teeth with abscess
- Teeth with pain or swelling
- Teeth with developmental disorders
- Teeth with adjacent soft tissue lesions
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 |
|---|---|---|
| no interventiontreatment of deep carious lesions | Other | no intervention |
| diode laserlaser light for cavity disinfection | Device | diode laser treatment |
| Aloe Veraherbal dietary supplement for treatment of deep carious lesions | Dietary supplement | Aloe Vera treatment |
Primary outcome
assessment of the remineralizing effect of aloe vera and diode laser on deep caries
Time frame: 6 months
remineralisation will be assessed by radiodensity using digital radiography
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 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Deep Caries
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Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
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Outcome of Selective Caries Removal Performed by Undergraduate Students
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Enrolling by invitation
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
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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.
Maha Niazy, professor study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diode laser and Aloe Vera in people with Deep 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 2 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: finished, as of the sponsor's last update on 14 Apr 2022. 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?
assessment of the remineralizing effect of aloe vera and diode laser on deep caries (time frame: 6 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 14 Apr 2022.