Pulp Therapy in Primary MolarsNCT07717294
Outcomes of Partial Pulpotomy VS Ful Pulpotomy Using MTA in Primary Teeth
A study testing NeoPUTTY MTA in people with Pulp Therapy in Primary Molars, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Background: Full pulpotomy has been the treatment of choice for normal or reversibly inflamed exposed pulps in primary molars. However, this approach has its own disadvantages and may be simplified down to a more conservative type of pulpotomies which is the "partial pulpotomy". Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Therapy in Primary Molars
- What is being tested?
- NeoPUTTY MTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jun 2025to 1 Jun 2027
- 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 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-8 years
- Medically fit or with mild systemic disease (ASA I or II),
- Able to attend all follow-up appointments
- Children with deeply carious pair-matched primary molars with normal or reversibly inflamed pulp that are indicated for pulpotomy (with almost radiographic caries exposure of the pulp).
- Children who are willing to take part in the study
- Children with valid parental consent
Who cannot join
- History of lingering or nocturnal pain, any clinical sign of pulp degeneration such as pathological mobility, tenderness to percussion/palpation, presence of fistulae or odontogenic facial swelling.
- The presence of radiologic signs of pulp infection/necrosis such as pathological external root resorption, internal resorption, bifurcation of apical radiolucency.
- Teeth with developmental dental anomalies, unrestorable crown or with advanced physiologic root resorption (> 1/3).
- Children with known allergy to any of the materials or medicaments used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Success of MTA Full Pulpotomy VS MTA Partial Pulpotomy; a Split-mouth Randomized Controlled Trial.
Background: Full pulpotomy has been the treatment of choice for normal or reversibly inflamed exposed pulps in primary molars. However, this approach has its own disadvantages and may be simplified down to a more conservative type of pulpotomies which is the "partial pulpotomy".
Though the literature is still lacking high quality studies on partial pulpotomy in primary molars.
Read more
Since MTA has demonstrated the highest success in the literature in comparison to other pulpotomy agents, it is going to be the choice in this trial. Aims: This study aims to investigate the success of partial vs full pulpotomies using MTA in vital primary molars without irreversible pulpitis. Methods: This is an RCT with a split-mouth design, comparing the radiographic and clinical changes of full vs partial MTA-pulpotomies over a one-year period in primary molars. The study will involve 25 healthy children, aged 4-8 years, who are attending JUST postgraduate clinics for dental treatment. Children with pair-matched primary molars that are present with advanced caries exposing the pulp or requiring pulpotomy will be enrolled. Teeth will be randomly assigned to either full or partial pulpotomy. Both procedures will be conducted under LA and rubber dam isolation.
The whole coronal pulp is going to be removed in full pulpotomy compared to 1-3 mm of the coronal pulp in partial pulpotomy. For both procedures, MTA will be placed, then the tooth will be restored with IRM, with the SSC as the final restoration. Afterwards, participants are going to be followed up clinically every 3 months, and radiographically every 6 months over the study period.
Expected results: partial pulpotomy is expected to be a viable alternative to the full pulpotomy, Partial pulpotomy might be recommended as a treatment option since it is more conservative to the pulp and involves less damage to the hard tissues rendering the tooth easier to restore. More importantly, the procedure is assumed to be less painful and more acceptable to young children with limited cooperation
- Conditions
- Pulp Therapy in Primary Molars
- Being tested
- NeoPUTTY MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoPUTTY MTAProcedure or surgery
Use for partial pulpotomy in primary molars
| Study group | Role | What they receive |
|---|---|---|
| Full pulpotomy | Active comparator | Not described Receives: Procedure: NeoPUTTY MTA |
| Partial pulpotomy | Experimental | Not described Receives: Procedure: NeoPUTTY MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Clinical evaluation will include the following parameters: pain, mobility, tenderness to percussion, periodontal pocket formation, gingival inflammation, and sinus tract formation. Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
Measured: 12 months
Radiographic Success
Radiographic evaluation will include the following parameters: periapical or furcal radiolucency, internal resorption, and external resorption. Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulp Therapy in Primary MolarsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717294
- Sponsor's protocol ID
- 20240554
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available for sharing upon reasonable request
Publications
Coll JA, Dhar V, Chen CY, Crystal YO, Guelmann M, Marghalani AA, AlShamali S, Xu Z, Glickman GN, Wedeward R. Use of Vital Pulp Therapies in Primary Teeth 2024. Pediatr Dent. 2024 Jan 15;46(1):13-26.
PubMed 38449041
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Success of MTA Full Pulpotomy VS MTA Partial Pulpotomy; a Split-mouth Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07717294
- Acronym / sponsor ID
- 20240554
- Conditions
- Pulp Therapy in Primary Molars
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 Jul 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.
Background: Full pulpotomy has been the treatment of choice for normal or reversibly inflamed exposed pulps in primary molars. However, this approach has its own disadvantages and may be simplified down to a more conservative type of pulpotomies which is the "partial pulpotomy".
Though the literature is still lacking high quality studies on partial pulpotomy in primary molars.
Since MTA has demonstrated the highest success in the literature in comparison to other pulpotomy agents, it is going to be the choice in this trial. Aims: This study aims to investigate the success of partial vs full pulpotomies using MTA in vital primary molars without irreversible pulpitis. Methods: This is an RCT with a split-mouth design, comparing the radiographic and clinical changes of full vs partial MTA-pulpotomies over a one-year period in primary molars. The study will involve 25 healthy children, aged 4-8 years, who are attending JUST postgraduate clinics for dental treatment. Children with pair-matched primary molars that are present with advanced caries exposing the pulp or requiring pulpotomy will be enrolled. Teeth will be randomly assigned to either full or partial pulpotomy. Both procedures will be conducted under LA and rubber dam isolation.
The whole coronal pulp is going to be removed in full pulpotomy compared to 1-3 mm of the coronal pulp in partial pulpotomy. For both procedures, MTA will be placed, then the tooth will be restored with IRM, with the SSC as the final restoration. Afterwards, participants are going to be followed up clinically every 3 months, and radiographically every 6 months over the study period.
Expected results: partial pulpotomy is expected to be a viable alternative to the full pulpotomy, Partial pulpotomy might be recommended as a treatment option since it is more conservative to the pulp and involves less damage to the hard tissues rendering the tooth easier to restore. More importantly, the procedure is assumed to be less painful and more acceptable to young children with limited cooperation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full pulpotomy | Active comparator | Procedure: NeoPUTTY MTA |
| Partial pulpotomy | Experimental | Procedure: NeoPUTTY MTA |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 4-8 years
- Medically fit or with mild systemic disease (ASA I or II),
- Able to attend all follow-up appointments
- Children with deeply carious pair-matched primary molars with normal or reversibly inflamed pulp that are indicated for pulpotomy (with almost radiographic caries exposure of the pulp).
- Children who are willing to take part in the study
Key exclusion criteria (4 listed)
- History of lingering or nocturnal pain, any clinical sign of pulp degeneration such as pathological mobility, tenderness to percussion/palpation, presence of fistulae or odontogenic facial swelling.
- The presence of radiologic signs of pulp infection/necrosis such as pathological external root resorption, internal resorption, bifurcation of apical radiolucency.
- Teeth with developmental dental anomalies, unrestorable crown or with advanced physiologic root resorption (> 1/3).
- Children with known allergy to any of the materials or medicaments used in the study.
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 MTAUse for partial pulpotomy in primary molars | Procedure or surgery | Full pulpotomy, Partial pulpotomy |
Primary outcome
Clinical success
Time frame: 12 months
Clinical evaluation will include the following parameters: pain, mobility, tenderness to percussion, periodontal pocket formation, gingival inflammation, and sinus tract formation. Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
Radiographic Success
Time frame: 12 months
Radiographic evaluation will include the following parameters: periapical or furcal radiolucency, internal resorption, and external resorption. Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
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 21 Jul 2026.
- Background: PubMed 38449041Coll JA, Dhar V, Chen CY, Crystal YO, Guelmann M, Marghalani AA, AlShamali S, Xu Z, Glickman GN, Wedeward R. Use of Vital Pulp Therapies in Primary Teeth 2024. Pediatr Dent. 2024 Jan 15;46(1):13-26.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data will be available for sharing upon reasonable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoPUTTY MTA in people with Pulp Therapy in Primary Molars, run by Jordan University of Science and Technology 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 6 inclusion and 4 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 21 Jul 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?
Clinical success (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT07717294, which also lists 1 linked publication.
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 Jul 2026.