Molar Incisor HypomineralizationNCT06137391
Effectiveness of Pulpotomy in Carious First Permanent Molar
A study testing Vital Pulp Therapy in people with Molar Incisor Hypomineralization, run by Alexandria University.
Trial summary
Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Vital Pulp Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- 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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7-13-year-old children.
- At least one deeply decayed first permanent molar, checked through periapical x-ray)
- Noncontributory medical history.
- The tooth should be showing irreversible pulpitis signs and symptoms.
- The tooth is restorable and probing pocket depth and mobility within normal limits.
- No signs of pulpal necrosis including sinus tract or swelling.
Who cannot join
- Non-restorable teeth.
- Negative response to cold testing.
- Presence of sinus tract or swelling.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled after partial pulpotomy in 6 minutes.
- Insufficient bleeding after pulp exposure; the pulp is judged necrotic or partially necrotic.
- History of analgesic intake 3 days prior to the day of commencement of procedure.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Partial Pulpotomy and Pulpotomy in Symptomatic Deeply Carious Permanent First Molars With Molar Incisor Hypomineralisation (24 Months Randomised Controlled Clinical Trial)
Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy.
The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months.
Read the detailed description
Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy. The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months. In this prospective randomized controlled clinical trial, a randomized assigned sample of 96 children each with a deeply carious young PFM, Group I (n=48) diagnosed with MIH and irreversible pulpitis and Group II (n=48) diagnosed with irreversible pulpitis but not affected with MIH. Group I will be randomly equally allocated into Group II A (n=24): partial pulpotomy (PP) and Group I B (n=24): full pulpotomy (FP). Group II will also be randomly equally allocated into Group II A (n=24): PP and Group II B (n=24): FP. If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). Teeth will be followed up clinically and radiographically using periapical x-rays for 24 months. Cone beam computed tomographic scans will be taken initially and at 24 months. Pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale. All data will be statistically analyzed and discussed considering the results obtained.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Vital Pulp Therapy
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital Pulp TherapyProcedure or surgery
Also called Apexogenesis, Pulpotomy, Partial Pulpotomy
The pulp is accessed after caries removal then the inflamed part of the pulp is excavated. After haemostasis is achieved, a pulpootmy medicament is used to coronally seal the remaining pulp tissue. In partial pulpotomy only part of the pulp chamber is excavated while in full pulpotomy the whole pulp chamber is excavated.
| Study group | Role | What they receive |
|---|---|---|
| MIH and irreversible pulpitis | Experimental | Group I (n=48) diagnosed with MIH and irreversible pulpitis. Group I will be randomly equally allocated into Group I A (n=24): partial pulpotomy (PP) and Group I B (n=24): full pulpotomy (FP). If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). Receives: Procedure: Vital Pulp Therapy |
| No MIH with irreversible pulpitis | Active comparator | Group II (n=48) diagnosed with irreversible pulpitis but not affected with MIH. Group II will be randomly equally allocated into Group II A (n=24): partial pulpotomy (PP) and Group II B (n=24): full pulpotomy (FP). If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). Receives: Procedure: Vital Pulp Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale, with 0 representing no pain and 100 representing pain as bad as it could be
Measured: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Digitalized periapical Radiographs
Standardized digitalized periapical radiographs will be taken.
Measured: Day 0, then at 6, 12, 18 and 24 months.
Cone Beam Computed Tomography scans
Cone Beam Computed Tomography scans will be taken initially and at 24 months only to avoid excessive radiation dose
Measured: Day 0, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodaina Helmy, Alexandria University
- Investigators
- Rodaina H. Helmy, Principal investigator, AlexU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137391
- Sponsor's protocol ID
- 0775-09/2023
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Partial Pulpotomy and Pulpotomy in Symptomatic Deeply Carious Permanent First Molars With Molar Incisor Hypomineralisation (24 Months Randomised Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06137391
- Acronym / sponsor ID
- 0775-09/2023
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (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.
Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy.
The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months.
Detailed description
Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy. The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months. In this prospective randomized controlled clinical trial, a randomized assigned sample of 96 children each with a deeply carious young PFM, Group I (n=48) diagnosed with MIH and irreversible pulpitis and Group II (n=48) diagnosed with irreversible pulpitis but not affected with MIH. Group I will be randomly equally allocated into Group II A (n=24): partial pulpotomy (PP) and Group I B (n=24): full pulpotomy (FP). Group II will also be randomly equally allocated into Group II A (n=24): PP and Group II B (n=24): FP. If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). Teeth will be followed up clinically and radiographically using periapical x-rays for 24 months. Cone beam computed tomographic scans will be taken initially and at 24 months. Pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale. All data will be statistically analyzed and discussed considering the results obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIH and irreversible pulpitis | Experimental | Procedure: Vital Pulp TherapyGroup I (n=48) diagnosed with MIH and irreversible pulpitis. Group I will be randomly equally allocated into Group I A (n=24): partial pulpotomy (PP) and Group I B (n=24): full pulpotomy (FP). If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). |
| No MIH with irreversible pulpitis | Active comparator | Procedure: Vital Pulp TherapyGroup II (n=48) diagnosed with irreversible pulpitis but not affected with MIH. Group II will be randomly equally allocated into Group II A (n=24): partial pulpotomy (PP) and Group II B (n=24): full pulpotomy (FP). If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 7-13-year-old children.
- At least one deeply decayed first permanent molar, checked through periapical x-ray)
- Noncontributory medical history.
- The tooth should be showing irreversible pulpitis signs and symptoms.
- The tooth is restorable and probing pocket depth and mobility within normal limits.
Key exclusion criteria (7 listed)
- Non-restorable teeth.
- Negative response to cold testing.
- Presence of sinus tract or swelling.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled after partial pulpotomy in 6 minutes.
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 TherapyAlso: Apexogenesis, Pulpotomy, Partial PulpotomyThe pulp is accessed after caries removal then the inflamed part of the pulp is excavated. After haemostasis is achieved, a pulpootmy medicament is used to coronally seal the remaining pulp tissue. In partial pulpotomy only part of the pulp chamber is excavated while in full pulpotomy the whole pulp chamber is excavated. | Procedure or surgery | MIH and irreversible pulpitis, No MIH with irreversible pulpitis |
Primary outcome
Pain assessment
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale, with 0 representing no pain and 100 representing pain as bad as it could be
Digitalized periapical Radiographs
Time frame: Day 0, then at 6, 12, 18 and 24 months.
Standardized digitalized periapical radiographs will be taken.
Cone Beam Computed Tomography scans
Time frame: Day 0, 24 months
Cone Beam Computed Tomography scans will be taken initially and at 24 months only to avoid excessive radiation dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Rodaina H. Helmy principal investigator
AlexU
Questions about this trial
What is this clinical trial studying?
A study testing Vital Pulp Therapy in people with Molar Incisor Hypomineralization, run by Alexandria 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 6 inclusion and 7 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 29 Nov 2023. 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 Rodaina H. Helmy (+201100001193, rodaina.helmy@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7). The study lists 3 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 29 Nov 2023.