Deep CariesNCT04763057
Indirect Pulp Treatment in Primary Teeth
A study testing NeoPUTTY MTA and calcium hydroxide in people with Deep Caries, run by Cairo University.
Trial summary
Conservative approaches such as indirect pulp capping techniques became popular over the last years for the management of deep carious lesions. In particular, indirect pulp-treatment (IPT) techniques have gained remarkable attention in pediatric dentistry, mainly because children require a fast and accurate treatment… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Deep Caries
- What is being tested?
- NeoPUTTY MTA and calcium hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Oct 2022
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Presence of active carious lesions involving either occlusal or proximal surfaces of primary molars.
- Extension of carious lesion such that complete caries removal would risk pulp exposure.
- History of tolerable dull intermittent pain, mild discomfort associated with eating, negative history of spontaneous extreme pain.
- Radiographically, carious lesion involving more than 2/3rd thickness of dentin approximating the pulp, normal lamina dura, normal periodontal ligament space, more than 2/3rd of root present, no periapical changes, no pathologic external or internal resorption.
Who cannot join
- • History of spontaneous sharp, penetrating pain, or tenderness on percussion
- Presence of tooth mobility, discoloration, sinus opening, or abscessed tooth.
- Radiographically, presence of interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption.
- Pulp exposure during caries removal.
- Parental refusal for participation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Calcium Hydroxide Versus NeoPUTTY MTA in Indirect Pulp Treatment of Primary Molars: A Randomized Clinical Trial
Conservative approaches such as indirect pulp capping techniques became popular over the last years for the management of deep carious lesions. In particular, indirect pulp-treatment (IPT) techniques have gained remarkable attention in pediatric dentistry, mainly because children require a fast and accurate treatment, besides it enables the affected primary tooth to remain in the mouth until exfoliation without causing any pain or infection.
Read the detailed description
Indirect pulp treatment is recommended for teeth with deep caries approximating the pulp with no signs and symptoms of pulp deterioration. In this treatment, the deepest layer of the remaining carious dentine (affected dentin) is covered with biocompatible material followed by an airtight restoration to achieve a good seal against microleakage, without the need to reencounter for the removal of remaining caries.
Calcium hydroxide has served as a gold standard for IPT over the years. However, the introduction of newer bioactive materials such as mineral trioxide aggregate (MTA) and Biodentine helped surpass the demerits of calcium hydroxide such as internal resorption, nonadherence to dentin, degradation over time, tunnel defects, and poor sealing ability.
- Conditions
- Deep Caries
- Being tested
- NeoPUTTY MTA, calcium hydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoPUTTY MTADrug
NeoPUTTY, a premixed bioactive bioceramic MTA that triggers hydroxyapatite and supports healing
calcium hydroxideDrug
Calcium hydroxide the gold standard for IPT
| Study group | Role | What they receive |
|---|---|---|
| indirect pulp treatment with NeoPUTTY MTA | Experimental | Not described Receives: Drug: NeoPUTTY MTA |
| indirect pulp treatment with calcium hydroxide | Active comparator | Not described Receives: Drug: calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success in term of the absence of post-operative pain
Visual analog scale
Measured: one year
Clinical success in term of the absence of pain on percussion, swelling, sinus, or fistula
Visual and clinical examinations
Measured: one year
Secondary outcomes (1)
Radiographic success in term of the absence of any adverse radiographic findings (eg. internal or external root resorption or other pathologic changes
Radiographic examination
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa aly fouad elchaghaby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763057
- Sponsor's protocol ID
- vital pulp treatment
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Hydroxide Versus NeoPUTTY MTA in Indirect Pulp Treatment of Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04763057
- Acronym / sponsor ID
- vital pulp treatment
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 21 Feb 2021 (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.
Conservative approaches such as indirect pulp capping techniques became popular over the last years for the management of deep carious lesions. In particular, indirect pulp-treatment (IPT) techniques have gained remarkable attention in pediatric dentistry, mainly because children require a fast and accurate treatment, besides it enables the affected primary tooth to remain in the mouth until exfoliation without causing any pain or infection.
Detailed description
Indirect pulp treatment is recommended for teeth with deep caries approximating the pulp with no signs and symptoms of pulp deterioration. In this treatment, the deepest layer of the remaining carious dentine (affected dentin) is covered with biocompatible material followed by an airtight restoration to achieve a good seal against microleakage, without the need to reencounter for the removal of remaining caries.
Calcium hydroxide has served as a gold standard for IPT over the years. However, the introduction of newer bioactive materials such as mineral trioxide aggregate (MTA) and Biodentine helped surpass the demerits of calcium hydroxide such as internal resorption, nonadherence to dentin, degradation over time, tunnel defects, and poor sealing ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indirect pulp treatment with NeoPUTTY MTA | Experimental | Drug: NeoPUTTY MTA |
| indirect pulp treatment with calcium hydroxide | Active comparator | Drug: calcium hydroxide |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Presence of active carious lesions involving either occlusal or proximal surfaces of primary molars.
Key exclusion criteria (5 listed)
- • History of spontaneous sharp, penetrating pain, or tenderness on percussion
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 |
|---|---|---|
| NeoPUTTY MTANeoPUTTY, a premixed bioactive bioceramic MTA that triggers hydroxyapatite and supports healing | Drug | indirect pulp treatment with NeoPUTTY MTA |
| calcium hydroxideCalcium hydroxide the gold standard for IPT | Drug | indirect pulp treatment with calcium hydroxide |
Primary outcome
Clinical success in term of the absence of post-operative pain
Time frame: one year
Visual analog scale
Clinical success in term of the absence of pain on percussion, swelling, sinus, or fistula
Time frame: one year
Visual and clinical examinations
1 secondary outcome
Radiographic success in term of the absence of any adverse radiographic findings (eg. internal or external root resorption or other pathologic changes
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing NeoPUTTY MTA and calcium hydroxide in people with Deep Caries, run by Cairo University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marwa aly elchaghaby, phd (01006231612, marwaaly2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success in term of the absence of post-operative pain (time frame: one year). The study lists 2 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 21 Feb 2021.