Molar HypomineralizationNCT07756216
Pulpotomy in Hypominerlized Permanent Molars.
A study testing Step wise pulpotomy in people with Molar Hypomineralization, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
The first permanent molars in children can sometimes develop a condition called molar-incisor hypomineralization (MIH), which affects the strength and quality of the tooth structure. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Hypomineralization
- What is being tested?
- Step wise pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 21 Dec 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • The patient age <14 years old
- Non -contributory medical history
- Molar tooth affected with MIH as per EAPD diagnostic criteria (17).
- Deep caries extending>= 2/3 of dentine or exposing the pulp on the radiograph
- The tooth should give positive response to cold sensibility testing
- Clinical diagnosis of reversible/irreversible pulpitis based on the symptoms and results of cold testing.
- The tooth is restorable, probing pocket depth and mobility are within normal limits
- No signs of pulpal necrosis including sinus tract or swelling
Who cannot join
- • Medically compromised patient.
- Non-restorable tooth.
- Signs of pulpal necrosis including sinus tract or swelling.
- Uncooperative children who could not be treated under local anesthesia.
- No enough bleeding after the pulpotomy procedure.
- Inability to achieve hemostasis within 8 min after the pulpotomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Pulpotomy in MIH Affected Teeth With Carious Pulp Exposure: A Prospective Clinical Study.
The first permanent molars in children can sometimes develop a condition called molar-incisor hypomineralization (MIH), which affects the strength and quality of the tooth structure. These teeth are more prone to breakdown and tooth decay, which may lead to inflammation of the dental pulp (the living tissue inside the tooth).
This study aims to evaluate the effectiveness of vital pulp therapy, a treatment designed to preserve the health of the pulp and maintain the tooth's function. The goal is to save the pulp tissue and reduce the need for more complex treatments such as root canal therapy.
Read the detailed description
Molar-incisor hypomineralization (MIH) is a developmental enamel defect affecting permanent first molars and incisors. Affected molars are more vulnerable to post-eruptive enamel breakdown, dental caries progression, and subsequent pulpal inflammation. When caries progresses to involve the pulp, preserving pulp vitality through vital pulp therapy (VPT) may provide an alternative to root canal treatment, particularly in young patients.
Although partial and full pulpotomy have shown favorable outcomes in young permanent teeth with deep caries and pulp exposure, limited evidence is available regarding their effectiveness in teeth affected by MIH. MIH-affected teeth may have altered pulpal characteristics, including increased vascularity, inflammatory response, and sensitivity, which may influence the response to vital pulp therapy.
This prospective clinical study aims to evaluate the clinical and radiographic outcomes of a stepwise pulpotomy approach in young permanent first molars affected by MIH with deep caries and pulp exposure. Eligible teeth will initially receive partial pulpotomy. If adequate hemostasis cannot be achieved following partial pulpotomy, treatment will be converted to full pulpotomy. A calcium silicate-based material will be used for pulp capping, followed by definitive restoration.
Clinical and patient-reported outcomes will be assessed, including postoperative pain, the need for emergency intervention, and signs or symptoms of treatment failure. Radiographic evaluation will be performed at 6 and 12 months using periapical radiographs, with additional imaging when indicated, to assess the presence of periapical or furcal pathology, root changes, and overall treatment success.
The study will also investigate potential factors associated with treatment outcomes, including patient and tooth characteristics, MIH severity, pulpotomy type performed (partial or full pulpotomy), and pulpal inflammatory markers such as matrix metalloproteinase-9 (MMP-9). The findings will contribute to understanding the effectiveness and predictability of vital pulp therapy for MIH-affected permanent molars with carious pulp exposure.
- Conditions
- Molar Hypomineralization
- Being tested
- Step wise pulpotomy
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step wise pulpotomyProcedure or surgery
The stepwise vital pulp therapy approach include : partial pulpotomy will be performed initially, and if adequate hemostasis cannot be achieved, the procedure will be converted to full pulpotomy to the level of the root canal orifices.
| Study group | Role | What they receive |
|---|---|---|
| MIH-Affected Permanent Molars Receiving Stepwise Pulpotomy Treatment | Experimental | MIH affected molars will receive a stepwise vital pulp therapy approach. Partial pulpotomy will be performed initially, and if adequate hemostasis cannot be achieved, the procedure will be converted to full pulpotomy. A calcium silicate-based pulp capping material and definitive restoration will be placed following the pulpotomy procedure. Participants will be followed clinically and radiographically for treatment outcomes. Receives: Procedure: Step wise pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of pulpotomy
Clinical and radiographic success will be assessed based on the presence or absence of signs and symptoms of treatment failure at follow-up visits. Clinical success will be defined as the absence of spontaneous pain, tenderness to percussion or palpation, swelling, sinus tract, abnormal mobility, or other clinical signs of pulpal or periapical disease. For teeth undergoing partial pulpotomy, continued positive response to pulp sensibility testing will also be considered a criterion for clinical success. Radiographic success will be defined as the absence of new pathological findings, including periapical or furcal radiolucency, root resorption, or other radiographic evidence of treatment failure on follow-up imaging.
Measured: 6 and 12 months after treatment
Secondary outcomes (1)
Postoperative pain after pulpotomy
Postoperative pain will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. Participants or their parents/guardians will report pain intensity following the pulpotomy procedure. The pain scores will be used to evaluate the postoperative pain response after vital pulp therapy.
Measured: One week after pulpotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start21 Dec 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar HypomineralizationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same stepwise vital pulp therapy protocol. Partial pulpotomy will be performed as the initial treatment approach. If adequate hemostasis cannot be achieved following partial pulpotomy, the procedure will be converted to full pulpotomy. The final treatment provided will therefore depend on the pulpal response during the procedure. Participants will be followed prospectively to evaluate clinical and radiographic outcomes after treatment.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessrin Taha, Jordan University of Science and Technology
- Investigators
- Nessrin Taha, DClinDent, PhD, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756216
- Sponsor's protocol ID
- 547/2025
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be publicly shared due to institutional regulations regarding data access and participant confidentiality. Requests for access to study data may be considered by the principal investigator following publication of the study results and in accordance with university policies and applicable ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Pulpotomy in MIH Affected Teeth With Carious Pulp Exposure: A Prospective Clinical Study.
- ClinicalTrials.gov ID
- NCT07756216
- Acronym / sponsor ID
- 547/2025
- Conditions
- Molar Hypomineralization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 21 Dec 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 10 Aug 2026 (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 first permanent molars in children can sometimes develop a condition called molar-incisor hypomineralization (MIH), which affects the strength and quality of the tooth structure. These teeth are more prone to breakdown and tooth decay, which may lead to inflammation of the dental pulp (the living tissue inside the tooth).
This study aims to evaluate the effectiveness of vital pulp therapy, a treatment designed to preserve the health of the pulp and maintain the tooth's function. The goal is to save the pulp tissue and reduce the need for more complex treatments such as root canal therapy.
Detailed description
Molar-incisor hypomineralization (MIH) is a developmental enamel defect affecting permanent first molars and incisors. Affected molars are more vulnerable to post-eruptive enamel breakdown, dental caries progression, and subsequent pulpal inflammation. When caries progresses to involve the pulp, preserving pulp vitality through vital pulp therapy (VPT) may provide an alternative to root canal treatment, particularly in young patients.
Although partial and full pulpotomy have shown favorable outcomes in young permanent teeth with deep caries and pulp exposure, limited evidence is available regarding their effectiveness in teeth affected by MIH. MIH-affected teeth may have altered pulpal characteristics, including increased vascularity, inflammatory response, and sensitivity, which may influence the response to vital pulp therapy.
This prospective clinical study aims to evaluate the clinical and radiographic outcomes of a stepwise pulpotomy approach in young permanent first molars affected by MIH with deep caries and pulp exposure. Eligible teeth will initially receive partial pulpotomy. If adequate hemostasis cannot be achieved following partial pulpotomy, treatment will be converted to full pulpotomy. A calcium silicate-based material will be used for pulp capping, followed by definitive restoration.
Clinical and patient-reported outcomes will be assessed, including postoperative pain, the need for emergency intervention, and signs or symptoms of treatment failure. Radiographic evaluation will be performed at 6 and 12 months using periapical radiographs, with additional imaging when indicated, to assess the presence of periapical or furcal pathology, root changes, and overall treatment success.
The study will also investigate potential factors associated with treatment outcomes, including patient and tooth characteristics, MIH severity, pulpotomy type performed (partial or full pulpotomy), and pulpal inflammatory markers such as matrix metalloproteinase-9 (MMP-9). The findings will contribute to understanding the effectiveness and predictability of vital pulp therapy for MIH-affected permanent molars with carious pulp exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same stepwise vital pulp therapy protocol. Partial pulpotomy will be performed as the initial treatment approach. If adequate hemostasis cannot be achieved following partial pulpotomy, the procedure will be converted to full pulpotomy. The final treatment provided will therefore depend on the pulpal response during the procedure. Participants will be followed prospectively to evaluate clinical and radiographic outcomes after treatment.
| Arm | Type | Receives |
|---|---|---|
| MIH-Affected Permanent Molars Receiving Stepwise Pulpotomy Treatment | Experimental | Procedure: Step wise pulpotomyMIH affected molars will receive a stepwise vital pulp therapy approach. Partial pulpotomy will be performed initially, and if adequate hemostasis cannot be achieved, the procedure will be converted to full pulpotomy. A calcium silicate-based pulp capping material and definitive restoration will be placed following the pulpotomy procedure. Participants will be followed clinically and radiographically for treatment outcomes. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- • The patient age <14 years old
Key exclusion criteria (6 listed)
- • Medically compromised patient.
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 |
|---|---|---|
| Step wise pulpotomyThe stepwise vital pulp therapy approach include : partial pulpotomy will be performed initially, and if adequate hemostasis cannot be achieved, the procedure will be converted to full pulpotomy to the level of the root canal orifices. | Procedure or surgery | MIH-Affected Permanent Molars Receiving Stepwise Pulpotomy Treatment |
Primary outcome
Success of pulpotomy
Time frame: 6 and 12 months after treatment
Clinical and radiographic success will be assessed based on the presence or absence of signs and symptoms of treatment failure at follow-up visits. Clinical success will be defined as the absence of spontaneous pain, tenderness to percussion or palpation, swelling, sinus tract, abnormal mobility, or other clinical signs of pulpal or periapical disease. For teeth undergoing partial pulpotomy, continued positive response to pulp sensibility testing will also be considered a criterion for clinical success. Radiographic success will be defined as the absence of new pathological findings, including periapical or furcal radiolucency, root resorption, or other radiographic evidence of treatment failure on follow-up imaging.
1 secondary outcome
Postoperative pain after pulpotomy
Time frame: One week after pulpotomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- A publication by the principal investigator that investigate quality of life after pulpotomy and presents its advantage.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be publicly shared due to institutional regulations regarding data access and participant confidentiality. Requests for access to study data may be considered by the principal investigator following publication of the study results and in accordance with university policies and applicable ethical requirements.
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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.
Nessrin Taha, DClinDent, PhD study chair
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step wise pulpotomy in people with Molar Hypomineralization, run by King Abdullah University Hospital at 1 site in Jordan.
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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Success of pulpotomy (time frame: 6 and 12 months after treatment). 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 12 Aug 2026.