Pulp Disease, DentalNCT06524076
Evaluation of Success Rate of Partial Pulpotomy Versus Complete Pulpotomy in Primary Molars Using NeoPUTTY MTA
A study testing Partial Pulpotomy and Complete pulpotomy in people with Pulp Disease, Dental, run by Cairo University.
Trial summary
Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA). Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- Partial Pulpotomy and Complete pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2024to 22 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients:
- Aged 4-7 years, in good general health and medically within normal.
- Teeth:
- Restorable mandibular second primary molars.
- History of reversible pulpitis.
- Preoperative radiograph:
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- Absence of periapical or inter-radicular radiolucency.
- Absence of widening of periodontal ligaments (PDL) space.
- Absence of internal or external root resorption.
Who cannot join
- Patients:
- With systemic disorders.
- Physical or mental disabilities.
- Unable to attend follow-up visits.
- Refusal of Participation.
- Refusal to sign the informed consent.
Show all 11Show fewer
- Teeth:
- Previously accessed teeth.
- Mobile mandibular second primary molar.
- Swelling in the vestibule or on palpation.
- Pain on percussion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiographic Evaluation of Partial Pulpotomy Versus Complete Pulpotomy in Vital Pulp Therapy in Primary Molars Using NeoPUTTY™ (MTA): Randomized Clinical Trial
Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).
Read the detailed description
Children with symptoms of reversible pulpitis in their second primary molar will be chosen to be enrolled in the study, and then randomly allocated into two groups. One group will undergo partial pulpotomy and the other group complete pulpotomy and followed up for 12 months. The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded.
- Informed consent from participating children's parents.
- Baseline records photographs, percussion test, periapical radiograph and personal data collection.
- Diagnostic chart with personal, medical and dental history will be filled.
- Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of vital pulp therapy technique that will be used then writing the patient's name and I.D. on it and will be opened after removing the carious lesion).
- Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
- Preoperative and Postoperative photographs will be taken.
- Conditions
- Pulp Disease, Dental
- Being tested
- Partial Pulpotomy, Complete pulpotomy
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial PulpotomyProcedure or surgery
After removing caries high-speed handpiece with water coolant using a round diamond bur. Once there is an exposure, the bur is changed with another sterile one with which the superficially inflamed pulp tissue will be gently removed to a depth of 1-3 mm beneath the pinpoint pulp exposure that occurred at the end of caries removal. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.
Complete pulpotomyProcedure or surgery
After removing caries with a large round bur, the access cavity will be opened. Excavation of inflamed coronal pulp tissues will be done using a sharp excavator. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Partial Pulpotomy | Experimental | Not described Receives: Procedure: Partial Pulpotomy |
| Complete pulpotomy | Active comparator | Not described Receives: Procedure: Complete pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain assessment through Visual Analog Scale (the lower the value the better).
Measured: one week postoperative
Swelling/ Fistula
Assessment of swelling and fistula through visual examination.
Measured: 3, 6, 9, 12 months
Mobility
Assesment of pathological mobility using mobility test.
Measured: 3, 6, 9, 12 months
Secondary outcomes (1)
Radiographic success
Radiographic evaluation (Radiolucency at furcation or periapical, internal or external root resorption) through visual interpretation of digital radiograph at 0, 6 and 12 months postoperatively.
Measured: 0, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start22 Sep 2024 (estimated)
- Primary completion22 Dec 2024 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Ayman, Cairo University
- Investigators
- Hany M. Saber, PHD, Study chair, Faculty of Dental Medicine, Cairo UniversityHanaa M. Abd El Moniem, PHD, Study director, Faculty of Dental Medicine, Cairo UniversityYara A. Badr, Masters, Principal investigator, Faculty of Dental Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524076
- Sponsor's protocol ID
- 28052024
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Partial Pulpotomy Versus Complete Pulpotomy in Vital Pulp Therapy in Primary Molars Using NeoPUTTY™ (MTA): Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06524076
- Acronym / sponsor ID
- 28052024
- Conditions
- Pulp Disease, Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Sep 2024 (estimated)
- Primary completion
- 22 Dec 2024 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 29 Jul 2024 (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.
Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).
Detailed description
Children with symptoms of reversible pulpitis in their second primary molar will be chosen to be enrolled in the study, and then randomly allocated into two groups. One group will undergo partial pulpotomy and the other group complete pulpotomy and followed up for 12 months. The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded.
- Informed consent from participating children's parents.
- Baseline records photographs, percussion test, periapical radiograph and personal data collection.
- Diagnostic chart with personal, medical and dental history will be filled.
- Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of vital pulp therapy technique that will be used then writing the patient's name and I.D. on it and will be opened after removing the carious lesion).
- Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
- Preoperative and Postoperative photographs will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Pulpotomy | Experimental | Procedure: Partial Pulpotomy |
| Complete pulpotomy | Active comparator | Procedure: Complete pulpotomy |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patients:
- Restorable mandibular second primary molars.
- History of reversible pulpitis.
- Absence of periapical or inter-radicular radiolucency.
- Absence of widening of periodontal ligaments (PDL) space.
Key exclusion criteria (11 listed)
- Patients:
- Previously accessed teeth.
- Mobile mandibular second primary molar.
- Swelling in the vestibule or on palpation.
- Pain on percussion.
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 |
|---|---|---|
| Partial PulpotomyAfter removing caries high-speed handpiece with water coolant using a round diamond bur. Once there is an exposure, the bur is changed with another sterile one with which the superficially inflamed pulp tissue will be gently removed to a depth of 1-3 mm beneath the pinpoint pulp exposure that occurred at the end of caries removal. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis. | Procedure or surgery | Partial Pulpotomy |
| Complete pulpotomyAfter removing caries with a large round bur, the access cavity will be opened. Excavation of inflamed coronal pulp tissues will be done using a sharp excavator. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis. | Procedure or surgery | Complete pulpotomy |
Primary outcome
Postoperative pain
Time frame: one week postoperative
Postoperative pain assessment through Visual Analog Scale (the lower the value the better).
Swelling/ Fistula
Time frame: 3, 6, 9, 12 months
Assessment of swelling and fistula through visual examination.
Mobility
Time frame: 3, 6, 9, 12 months
Assesment of pathological mobility using mobility test.
1 secondary outcome
Radiographic success
Time frame: 0, 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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.
Hany M. Saber, PHD study chair
Faculty of Dental Medicine, Cairo University
Hanaa M. Abd El Moniem, PHD study director
Faculty of Dental Medicine, Cairo University
Yara A. Badr, Masters principal investigator
Faculty of Dental Medicine, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Partial Pulpotomy and Complete pulpotomy in people with Pulp Disease, Dental, run by Cairo 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 9 inclusion and 11 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 14 Aug 2024. 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 Yara A. Badr, Masters (+201001151170, yara.badr@dentistry.cu.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: one week postoperative). 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 14 Aug 2024.