Deep CariesNCT05020223
Comparison of Sucess of Pulpotomy, Direct Pulp Capping and Indirect Pulp Capping Modalities Using MTA in Primary Teeth
A study testing Vital pulp therapy in people with Deep Caries, run by Minia University at 1 site in Egypt.
Trial summary
450 healthy children with primary teeth of deep carious lesions without signs or symptomes of irreverisible pulp damage was selected randompy divoded into 3 groups each of 150 children that inder go vital pulp therapy through pulpotomy,direct pulp capping or indirect pulp capping using MTA as capping material for each… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Deep Caries
- What is being tested?
- Vital pulp therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Sep 2023
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children
- Aged from 3 to 10 years old
- Deep cariuos primary tooth
Who cannot join
- Primary teeth with any signs or syptoms of irreversible pulpitis
- Primary teeth of any signs or symptomes of vitality loss
- Primary teeth near to exfoliation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University
Minya, 61111
Ahmad Elheeny, PhD, 00201005560337, ahmed.elheny@yahoo.com
About this study
Official title: Comparison of Sucess of Pulpotomy, Direct Pulp Capping and Indirect Pulp Capping Modalities Using MTA in Primary Teeth (2 Years Follow up)
450 healthy children with primary teeth of deep carious lesions without signs or symptomes of irreverisible pulp damage was selected randompy divoded into 3 groups each of 150 children that inder go vital pulp therapy through pulpotomy,direct pulp capping or indirect pulp capping using MTA as capping material for each modality then followed up for 2 years or more
- Conditions
- Deep Caries
- Being tested
- Vital pulp therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital pulp therapyOther
Vital pulp therapy different modalities for management of deep carious lesion in primary teeth
| Study group | Role | What they receive |
|---|---|---|
| MTA pulpotomy | Experimental | Usuing MTA as capping material for cervical pulpotomy as a treatment option for deep carious primary teeth with signs and symptoms of reversible pulpitis in presence of pulp exposure Receives: Other: Vital pulp therapy |
| MTA direct pulp capping | Experimental | Using MTA as capping material in case of trearment of deep carious primary teeth with signs and symptoms of reversible pulpitis with presence of pulp exposure Receives: Other: Vital pulp therapy |
| MTA indirect pulp capping | Experimental | Using MTA as indirect capping material for treatment of deep carious primary teeth with signs and symptoms of reversible pulpitis Receives: Other: Vital pulp therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tenderness
Precence or abscence
Measured: 2 years
Abcess
Precence or abscence
Measured: 2 years
Fistula
Precence or abscence
Measured: 2 years
lamina dura
Intact or distorted
Measured: 2 years
Periapical radiographic radiolucency
Precence or abcencs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (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 Minia 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mahmoud, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020223
- Sponsor's protocol ID
- 601
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 25 Aug 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 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sucess of Pulpotomy, Direct Pulp Capping and Indirect Pulp Capping Modalities Using MTA in Primary Teeth (2 Years Follow up)
- ClinicalTrials.gov ID
- NCT05020223
- Acronym / sponsor ID
- 601
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 25 Aug 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.
450 healthy children with primary teeth of deep carious lesions without signs or symptomes of irreverisible pulp damage was selected randompy divoded into 3 groups each of 150 children that inder go vital pulp therapy through pulpotomy,direct pulp capping or indirect pulp capping using MTA as capping material for each modality then followed up for 2 years or more
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MTA pulpotomy | Experimental | Other: Vital pulp therapyUsuing MTA as capping material for cervical pulpotomy as a treatment option for deep carious primary teeth with signs and symptoms of reversible pulpitis in presence of pulp exposure |
| MTA direct pulp capping | Experimental | Other: Vital pulp therapyUsing MTA as capping material in case of trearment of deep carious primary teeth with signs and symptoms of reversible pulpitis with presence of pulp exposure |
| MTA indirect pulp capping | Experimental | Other: Vital pulp therapyUsing MTA as indirect capping material for treatment of deep carious primary teeth with signs and symptoms of reversible pulpitis |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children
- Aged from 3 to 10 years old
- Deep cariuos primary tooth
Key exclusion criteria (3 listed)
- Primary teeth with any signs or syptoms of irreversible pulpitis
- Primary teeth of any signs or symptomes of vitality loss
- Primary teeth near to exfoliation
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 |
|---|---|---|
| Vital pulp therapyVital pulp therapy different modalities for management of deep carious lesion in primary teeth | Other | MTA direct pulp capping, MTA indirect pulp capping, MTA pulpotomy |
Primary outcome
Tenderness
Time frame: 2 years
Precence or abscence
Abcess
Time frame: 2 years
Precence or abscence
Fistula
Time frame: 2 years
Precence or abscence
lamina dura
Time frame: 2 years
Intact or distorted
Periapical radiographic radiolucency
Time frame: 2 years
Precence or abcencs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
Related trials for Deep Caries
RecruitingPhase 2
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
Deep Caries
Recruiting
"The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."
Moderate Severe Pulpitis, Extremely Deep Caries
Recruiting
Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
Dental Caries, Dental Cavities
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital pulp therapy in people with Deep Caries, run by Minia 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 3 inclusion and 3 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 25 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud A Mahmoud (01009578837, Mam.dent@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tenderness (time frame: 2 years). The study lists 5 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 25 Aug 2021.