Evaluation of Success Rate of Partial Pulpotomy Versus Complete Pulpotomy in Primary Molars Using NeoPUTTY MTA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Partial Pulpotomy, Complete pulpotomy.
- Who it may be relevant to
- Registry conditions: Pulp Disease, Dental. Basic parameters: 4 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
1. Informed consent from participating children's parents. 2. Baseline records photographs, percussion test, periapical radiograph and personal data collection. 3. Diagnostic chart with personal, medical and dental history will be filled. 4. 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). 5. Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination). 6. Preoperative and Postoperative photographs will be taken.
Interventions
- Procedure Partial Pulpotomy
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. - Procedure Complete pulpotomy
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.
Primary outcome measures
- Postoperative pain [Time frame: one week postoperative]
- Swelling/ Fistula [Time frame: 3, 6, 9, 12 months]
- Mobility [Time frame: 3, 6, 9, 12 months]
Secondary outcome measures (1)
- Radiographic success [Time frame: 0, 6, 12 months]
Eligibility criteria
Inclusion criteria
- 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:
- Absence of periapical or inter-radicular radiolucency.
- Absence of widening of periodontal ligaments (PDL) space.
- Absence of internal or external root resorption.
Exclusion criteria
- Patients:
- With systemic disorders.
- Physical or mental disabilities.
- Unable to attend follow-up visits.
- Refusal of Participation.
- Refusal to sign the informed consent.
Teeth:
- Previously accessed teeth.
- Mobile mandibular second primary molar.
- Swelling in the vestibule or on palpation.
- Pain on percussion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06524076 · 28052024