Indirect Pulp CappingNCT05554952
Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries
A study testing MTA in people with Indirect Pulp Capping and Pulpotomy, run by Minia University at 2 sites in Egypt.
Trial summary
The aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Indirect Pulp Capping, Pulpotomy
- What is being tested?
- MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2021to Nov 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- - 4 to 6 years old patients presented with deep carious lesions in primary molars.
- Apparently healthy children (ASA I, II classification).
- Co-operative children (Rating 3 \& 4 according to Frankle classification)
Who cannot join
- Clinical:
- Non restorable primary molars.
- Presence of clinical pathology.
- Presence of mobility or tenderness to percussion.
- Spontaneous pain.
- Radiographic:
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- Pre-operative radiographs showed external or internal root resorption.
- Presence of furcal radiolucency.
- Presence of periapical radiolucency or widened periodontal ligament space
- More than one-third root resorption detected.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries: An Equivalent Parallel Randomized Controlled Trial
The aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period.
Read the detailed description
Output patients coming to Pediatric dentistry department Minia University, selected randomly to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period an equivalent parallel randomized controlled trial
- Conditions
- Indirect Pulp Capping, Pulpotomy
- Being tested
- MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTACombination product
Mineral trioxide aggregate (MTA) is composed of Portland cement, with 4:1 addition of bismuth oxide added so that the material can be detected on a radiograph. The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Indirect pulp capping with MTA Receives: Combination Product: MTA |
| Group 2 | Active comparator | Pulpotomy with MTA Receives: Combination Product: MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic evaluation
The children will be recalled for postoperative clinical and radiographic assessment at the following intervals: 3, 6, 12 months the treatment will be considered successful if none of the following clinical or radiographic findings is present:
Clinical criteria:
- pain
- tenderness to palpation or percussion
- gingival swelling or sinus tract
- purulent exudate expressed from the gingival margin
- abnormal tooth mobility
Radiographic criteria:
- periapical radiolucency
- widening in peridontal ligament space
Measured: 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Nov 2021
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect Pulp CappingStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa monis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554952
- Sponsor's protocol ID
- 526_1 /11/2021
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 26 Sep 2022
- 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 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries: An Equivalent Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05554952
- Acronym / sponsor ID
- 526_1 /11/2021
- Conditions
- Indirect Pulp Capping, Pulpotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 26 Sep 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 aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period.
Detailed description
Output patients coming to Pediatric dentistry department Minia University, selected randomly to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period an equivalent parallel randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Combination Product: MTAIndirect pulp capping with MTA |
| Group 2 | Active comparator | Combination Product: MTAPulpotomy with MTA |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- - 4 to 6 years old patients presented with deep carious lesions in primary molars.
- Apparently healthy children (ASA I, II classification).
- Co-operative children (Rating 3 \& 4 according to Frankle classification)
Key exclusion criteria (10 listed)
- Clinical:
- Non restorable primary molars.
- Presence of clinical pathology.
- Presence of mobility or tenderness to percussion.
- Radiographic:
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 |
|---|---|---|
| MTAMineral trioxide aggregate (MTA) is composed of Portland cement, with 4:1 addition of bismuth oxide added so that the material can be detected on a radiograph. The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate. | Combination product | Group 1, Group 2 |
Primary outcome
Clinical and radiographic evaluation
Time frame: 2 years follow up
The children will be recalled for postoperative clinical and radiographic assessment at the following intervals: 3, 6, 12 months the treatment will be considered successful if none of the following clinical or radiographic findings is present: Clinical criteria: 1. pain 2. tenderness to palpation or percussion 3. gingival swelling or sinus tract 4. purulent exudate expressed from the gingival margin 5. abnormal tooth mobility Radiographic criteria: 1. periapical radiolucency 2. widening in peridontal ligament space
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTA in people with Indirect Pulp Capping and Pulpotomy, run by Minia University at 2 sites 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 10 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 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Clinical and radiographic evaluation (time frame: 2 years follow up). 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 26 Sep 2022.