Caries ArrestedNCT06585436
Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments
A study testing partial caries removal in people with Caries Arrested, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The study involved 54 adult patients between the ages of 18 and 50 years who had a posterior permanent tooth with a deep occlusal (Class I) carious lesion that extended to the inner third of the dentin (D3) and divided them into two equal groups randomly (N=27) according to the caries removal technique: group 1 (SE)… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Arrested
- What is being tested?
- partial caries removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Aug 2024
- 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
- Patients with first and second molars with occlusal deep carious lesions (Class I) extending to the inner third of dentin thickness on radiographic examination using (i-sensor H1, Woodpecker, China).
- Teeth with a healthy response to the electrical pulp tester (DY 310, Denjoy Dental CO., LTD, China).
- Teeth with the absence of spontaneous pain.
- Teeth with a negative sensitivity to percussion.
- Teeth with the absence of periapical lesions by a digital radiographic examination.
- Clinically, all teeth were without any mobility.
- Patients who will complete the procedure of follow up.
- Patients who will sign the consent.
Who cannot join
- Mutilated teeth or teeth with caries extending subgingivally.
- Teeth with the existence of previous restorations.
- Teeth with periodontal disease, any swelling, fistulas, signs of irreversible pulpitis or necrotic pulp.
- Teeth with roots showing external or internal resorption.
- Pregnant women.
- Presence of any systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments: An in Vivo Study
The study involved 54 adult patients between the ages of 18 and 50 years who had a posterior permanent tooth with a deep occlusal (Class I) carious lesion that extended to the inner third of the dentin (D3) and divided them into two equal groups randomly (N=27) according to the caries removal technique: group 1 (SE), and group 2 (SW). Then each main group was equally subdivided into three equal subgroups (n=9) according to the applied dentin dressing material as follows: Subgroup 1: Nano-silver compound (NSC), Subgroup 2: Chitosan-loaded nano hydroxy apatite (CS/N-HAp), Subgroup 3: Bioactive glass ionomer (N-BAG/GIC). At the first visit both groups received the same treatment of incomplete caries excavation, application of dentin dressing materials and sealing temporarily for 3-months with a glass ionomer cement (GIC). At the second visit the GIC reduced pulpally in (SE) group leaving 2 mm as base and completely removal the remaining carious lesion in (SW) group then re-application of same dentin dressing material on each tooth and GIC as a base. Finally, all cavities were restored with selective enamel etching technique, after which self-etch adhesive and Nano-filled composite resin are applied according to manufacturer instructions. The clinical and digital radiographic evaluations of the success and failure rates were performed at: baseline (7 days), 3, 12, and 18-months.
- Conditions
- Caries Arrested
- Being tested
- partial caries removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial caries removalProcedure or surgery
removal of all cavity caries except last layer related to the pulp
| Study group | Role | What they receive |
|---|---|---|
| selective removal (chitosan loaded nano hydroxyapatite ) | Experimental | selective removal then apply chitosan loaded nano hydroxyapatite Receives: Procedure: partial caries removal |
| selective removal (nano bioactive glass/GIC) | Experimental | selective removal then apply (nano bioactive glass/GIC) Receives: Procedure: partial caries removal |
| selective removal (nanosilver) | Experimental | selective removal then apply (nanosilver) Receives: Procedure: partial caries removal |
| stepwise removal (chitosan loaded nano hydroxyapatite ) | Experimental | stepwise removal then apply (chitosan loaded nano hydroxyapatite ) Receives: Procedure: partial caries removal |
| stepwise removal (nano bioactive glass/GIC) | Experimental | selective removal (nano bioactive glass/GIC) Receives: Procedure: partial caries removal |
| stepwise removal (nanosilver) | Experimental | selective removal then apply (nanosilver) Receives: Procedure: partial caries removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
evaluation of the post operative pain following restorations using modified USPHS
Measured: 7 days
post operative pain
evaluation of the post operative pain following restorations using modified USPHS
Measured: 3 months
post operative pain
evaluation of the post operative pain following restorations using modified USPHS
Measured: 12 months
post operative pain
evaluation of the post operative pain following restorations using modified USPHS
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Feb 2023
- Primary completion1 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries ArrestedStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abdallah Rabiea, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585436
- Sponsor's protocol ID
- 2/9/2022
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments: An in Vivo Study
- ClinicalTrials.gov ID
- NCT06585436
- Acronym / sponsor ID
- 2/9/2022
- Conditions
- Caries Arrested
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 5 Sep 2024 (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 study involved 54 adult patients between the ages of 18 and 50 years who had a posterior permanent tooth with a deep occlusal (Class I) carious lesion that extended to the inner third of the dentin (D3) and divided them into two equal groups randomly (N=27) according to the caries removal technique: group 1 (SE), and group 2 (SW). Then each main group was equally subdivided into three equal subgroups (n=9) according to the applied dentin dressing material as follows: Subgroup 1: Nano-silver compound (NSC), Subgroup 2: Chitosan-loaded nano hydroxy apatite (CS/N-HAp), Subgroup 3: Bioactive glass ionomer (N-BAG/GIC). At the first visit both groups received the same treatment of incomplete caries excavation, application of dentin dressing materials and sealing temporarily for 3-months with a glass ionomer cement (GIC). At the second visit the GIC reduced pulpally in (SE) group leaving 2 mm as base and completely removal the remaining carious lesion in (SW) group then re-application of same dentin dressing material on each tooth and GIC as a base. Finally, all cavities were restored with selective enamel etching technique, after which self-etch adhesive and Nano-filled composite resin are applied according to manufacturer instructions. The clinical and digital radiographic evaluations of the success and failure rates were performed at: baseline (7 days), 3, 12, and 18-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| selective removal (chitosan loaded nano hydroxyapatite ) | Experimental | Procedure: partial caries removalselective removal then apply chitosan loaded nano hydroxyapatite |
| selective removal (nano bioactive glass/GIC) | Experimental | Procedure: partial caries removalselective removal then apply (nano bioactive glass/GIC) |
| selective removal (nanosilver) | Experimental | Procedure: partial caries removalselective removal then apply (nanosilver) |
| stepwise removal (chitosan loaded nano hydroxyapatite ) | Experimental | Procedure: partial caries removalstepwise removal then apply (chitosan loaded nano hydroxyapatite ) |
| stepwise removal (nano bioactive glass/GIC) | Experimental | Procedure: partial caries removalselective removal (nano bioactive glass/GIC) |
| stepwise removal (nanosilver) | Experimental | Procedure: partial caries removalselective removal then apply (nanosilver) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with first and second molars with occlusal deep carious lesions (Class I) extending to the inner third of dentin thickness on radiographic examination using (i-sensor H1, Woodpecker, China).
- Teeth with a healthy response to the electrical pulp tester (DY 310, Denjoy Dental CO., LTD, China).
- Teeth with the absence of spontaneous pain.
- Teeth with a negative sensitivity to percussion.
- Teeth with the absence of periapical lesions by a digital radiographic examination.
Key exclusion criteria (6 listed)
- Mutilated teeth or teeth with caries extending subgingivally.
- Teeth with the existence of previous restorations.
- Teeth with periodontal disease, any swelling, fistulas, signs of irreversible pulpitis or necrotic pulp.
- Teeth with roots showing external or internal resorption.
- Pregnant women.
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 |
|---|---|---|
| partial caries removalremoval of all cavity caries except last layer related to the pulp | Procedure or surgery | selective removal (chitosan loaded nano hydroxyapatite ), selective removal (nano bioactive glass/GIC), selective removal (nanosilver), stepwise removal (chitosan loaded nano hydroxyapatite ), stepwise removal (nano bioactive glass/GIC), stepwise removal (nanosilver) |
Primary outcome
post operative pain
Time frame: 7 days
evaluation of the post operative pain following restorations using modified USPHS
post operative pain
Time frame: 3 months
evaluation of the post operative pain following restorations using modified USPHS
post operative pain
Time frame: 12 months
evaluation of the post operative pain following restorations using modified USPHS
post operative pain
Time frame: 18 months
evaluation of the post operative pain following restorations using modified USPHS
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 5 Sep 2024.
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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 partial caries removal in people with Caries Arrested, 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 8 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 5 Sep 2024. 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?
post operative pain (time frame: 7 days). The study lists 4 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 5 Sep 2024.