Deep Caries in Primary MolarsNCT07437794
Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars
A study testing NeoPutty MTA and Formocresol in people with Deep Caries in Primary Molars, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to evaluate the clinical and radiographic success of NeoPutty MTA compared to formocresol in vital pulpotomy of mandibular primary molars in children aged 4 to 9 years. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Deep Caries in Primary Molars
- What is being tested?
- NeoPutty MTA and Formocresol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 May 2026
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children with asymptomatic decayed primary mandibular molar(s).
- Patient and parent showing cooperation and compliance.
- Children 4-9 years old.
- Vital carious primary(s) with complete root formation.
- Asymptomatic teeth or without clinical symptoms of spontaneous pain.
- No clinical evidence of pulp degeneration like the history of spontaneous or nocturnal pain, tenderness to percussion, pathologic tooth mobility, swelling, or fistulous tract.
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- Both genders will be included.
- No radiographic evidence of pulp degeneration such as internal root resorption, external root resorption, or furcal radiolucency.
- Presence of two thirds of the root.
- Teeth that can be restored.
- Children with prior parental consent.
Who cannot join
- History of any systemic disease.
- Hemostasis is not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement.
- The remaining radicular tissue was non-vital (with suppuration or purulence necrosis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
October university for modern sciences and arts
Giza, Giza Governorate, 12116
Ahmed Shawky, +201124465202, ahmed.shawky3@msa.edu.eg
About this study
Official title: Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars: A Randomized Clinical Trial
This randomized clinical trial aims to evaluate the clinical and radiographic success of NeoPutty MTA compared to formocresol in vital pulpotomy of mandibular primary molars in children aged 4 to 9 years. Participants will be randomly allocated into two groups (1:1) to receive pulpotomy using either NeoPutty MTA or formocresol, followed by restoration with stainless steel crowns. Clinical and radiographic outcomes will be assessed during follow-up visits.
Read the detailed description
Pulpotomy is a commonly performed vital pulp therapy in pediatric dentistry. Formocresol has been widely used due to its high clinical success; however, concerns exist regarding its potential toxicity. NeoPutty MTA is a premixed bioceramic material introduced as an alternative pulpotomy agent with improved handling properties and bioactivity. This randomized parallel-group clinical trial will compare NeoPutty MTA versus formocresol in vital pulpotomy of mandibular primary molars. Children aged 4-9 years presenting with asymptomatic carious mandibular primary molars will be recruited from the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Eligible teeth will undergo standardized pulpotomy procedures, restoration with glass ionomer cement, and stainless steel crowns. Clinical and radiographic follow-up will be performed at scheduled intervals to evaluate success and failure outcomes.
- Conditions
- Deep Caries in Primary Molars
- Being tested
- NeoPutty MTA, Formocresol
- Keywords
- Deep Caries in Primary Molars, NeoPutty MTA, Mineral Trioxide Aggregate, Formocresol, Vital Pulp Therapy, Pulpotomy, Stainless Steel Crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoPutty MTADrug
NeoPutty MTA (NuSmile) will be placed directly over the radicular pulp stumps after hemostasis, then the tooth will be sealed with resin-modified glass ionomer cement and restored with stainless steel crown.
FormocresolDrug
A sterile cotton pellet lightly moistened with a 1:5 dilution of Buckley's formocresol will be placed against the pulp stumps for 3-5 minutes, then removed. Reinforced zinc oxide eugenol will be placed, followed by glass ionomer cement and stainless steel crown restoration.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: NeoPutty MTA Pulpotomy | Experimental | Participants will receive vital pulpotomy of mandibular primary molars using NeoPutty MTA as the pulpotomy medicament, followed by restoration with glass ionomer cement and stainless steel crown. Receives: Drug: NeoPutty MTA |
| Arm B: Formocresol Pulpotomy | Active comparator | Participants will receive vital pulpotomy of mandibular primary molars using formocresol (1:5 dilution of Buckley's formocresol) applied with cotton pellet, followed by reinforced zinc oxide eugenol, glass ionomer cement, and stainless steel crown. Receives: Drug: Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Presence or absence of spontaneous postoperative pain reported by the child/parent after pulpotomy treatment.
Measured: 1 week postoperatively, 3 months, 6 months, 9 months and 12 months
Secondary outcomes (6)
Pain on percussion
Description: Presence or absence of pain on percussion during clinical follow-up visits.
Measured: 3 months, 6 months, 9 months and 12 months
Presence of sinus tract, fistula or abscess
Description: Clinical evaluation for presence of swelling, abscess, or sinus/fistulous tract related to the treated tooth.
Measured: 3 months, 6 months, 9 months and 12 months
Tooth mobility
Description: Tooth mobility assessed clinically using a mobility scoring system ranges from 0-3 were (score 0 the best) indicates no mobility and (score 3 the worst) indicates vertical and horizontal mobility.
Measured: 3 months, 6 months, 9 months and 12 months
Widening of Periodontal Ligament Space
Radiographic evidence of widening of the periodontal ligament space assessed using standardized periapical radiographs. Recorded as Present / Absent.
Measured: 6 months and 12 months after treatment
Internal and External Root Resorption
Radiographic evidence of internal or external root resorption observed on periapical radiographs. Recorded as Present / Absent.
Measured: 6 months and 12 months after treatment
Furcal or Periapical Radiolucency
Presence of radiolucent lesion in the furcation or periapical area detected on standardized periapical radiographs. Recorded as Present / Absent.
Measured: 6 months and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Caries 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shawky Amer, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437794
- Sponsor's protocol ID
- Ahmed MSA University
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07437794
- Acronym / sponsor ID
- Ahmed MSA University
- Conditions
- Deep Caries in Primary Molars
- Keywords
- Deep Caries in Primary Molars, NeoPutty MTA, Mineral Trioxide Aggregate, Formocresol, Vital Pulp Therapy, Pulpotomy, Stainless Steel Crown
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 27 Feb 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.
This randomized clinical trial aims to evaluate the clinical and radiographic success of NeoPutty MTA compared to formocresol in vital pulpotomy of mandibular primary molars in children aged 4 to 9 years. Participants will be randomly allocated into two groups (1:1) to receive pulpotomy using either NeoPutty MTA or formocresol, followed by restoration with stainless steel crowns. Clinical and radiographic outcomes will be assessed during follow-up visits.
Detailed description
Pulpotomy is a commonly performed vital pulp therapy in pediatric dentistry. Formocresol has been widely used due to its high clinical success; however, concerns exist regarding its potential toxicity. NeoPutty MTA is a premixed bioceramic material introduced as an alternative pulpotomy agent with improved handling properties and bioactivity. This randomized parallel-group clinical trial will compare NeoPutty MTA versus formocresol in vital pulpotomy of mandibular primary molars. Children aged 4-9 years presenting with asymptomatic carious mandibular primary molars will be recruited from the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Eligible teeth will undergo standardized pulpotomy procedures, restoration with glass ionomer cement, and stainless steel crowns. Clinical and radiographic follow-up will be performed at scheduled intervals to evaluate success and failure outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: NeoPutty MTA Pulpotomy | Experimental | Drug: NeoPutty MTAParticipants will receive vital pulpotomy of mandibular primary molars using NeoPutty MTA as the pulpotomy medicament, followed by restoration with glass ionomer cement and stainless steel crown. |
| Arm B: Formocresol Pulpotomy | Active comparator | Drug: FormocresolParticipants will receive vital pulpotomy of mandibular primary molars using formocresol (1:5 dilution of Buckley's formocresol) applied with cotton pellet, followed by reinforced zinc oxide eugenol, glass ionomer cement, and stainless steel crown. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Children with asymptomatic decayed primary mandibular molar(s).
- Patient and parent showing cooperation and compliance.
- Children 4-9 years old.
- Vital carious primary(s) with complete root formation.
- Asymptomatic teeth or without clinical symptoms of spontaneous pain.
Key exclusion criteria (3 listed)
- History of any systemic disease.
- Hemostasis is not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement.
- The remaining radicular tissue was non-vital (with suppuration or purulence necrosis).
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 MTANeoPutty MTA (NuSmile) will be placed directly over the radicular pulp stumps after hemostasis, then the tooth will be sealed with resin-modified glass ionomer cement and restored with stainless steel crown. | Drug | Arm A: NeoPutty MTA Pulpotomy |
| FormocresolA sterile cotton pellet lightly moistened with a 1:5 dilution of Buckley's formocresol will be placed against the pulp stumps for 3-5 minutes, then removed. Reinforced zinc oxide eugenol will be placed, followed by glass ionomer cement and stainless steel crown restoration. | Drug | Arm B: Formocresol Pulpotomy |
Primary outcome
Postoperative pain
Time frame: 1 week postoperatively, 3 months, 6 months, 9 months and 12 months
Presence or absence of spontaneous postoperative pain reported by the child/parent after pulpotomy treatment.
6 secondary outcomes
Pain on percussion
Time frame: 3 months, 6 months, 9 months and 12 months
Presence of sinus tract, fistula or abscess
Time frame: 3 months, 6 months, 9 months and 12 months
Tooth mobility
Time frame: 3 months, 6 months, 9 months and 12 months
Widening of Periodontal Ligament Space
Time frame: 6 months and 12 months after treatment
Internal and External Root Resorption
Time frame: 6 months and 12 months after treatment
Furcal or Periapical Radiolucency
Time frame: 6 months and 12 months after treatment
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 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Deep Caries in Primary Molars
Recruiting
SMART With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.
Caries; Dentin
Not yet recruiting
Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars
Deep Caries Lesion of Primary Teeth, Dental Pulp Diseases
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.
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 and Formocresol in people with Deep Caries in Primary Molars, run by October University for Modern Sciences and Arts 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 11 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: opening soon, as of the sponsor's last update on 27 Feb 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 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?
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?
Contact Ahmed Shawky, bachelor of dentistry (+201124465202, ahmed.shawky3@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 1 week postoperatively, 3 months, 6 months, 9 months and 12 months). 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 27 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.