About this trial
The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy children aged between 3 and 10 years
Primary molars with no history of spontaneous or persistent pain
Restorable primary molars with deep carious lesions approximating or reaching the pulp
Primary molars with at least 2/3rd of the root length present
Disqualifiers
Primary molars with pathological mobility, tenderness to percussion, swelling, or sinus tract
Primary molars without hemostasis after coronal pulp amputation within five minutes.
Primary molars with widening of the periodontal ligament (PDL) space; pathologic internal or external root resorption; and apical or furcal radiolucency
Trial design
Parallel
Treatments tested in this trial
Primary molars pulpotomies with NeoMTA
Other interventionPrimary molar pulpotomies will be performed by trained dentists using NeoMTA, a bioactive material containing calcium silicate known for its bio-active and bone forming potential. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess success rate, and clinical and radiographic outcomes
Primary molar pulpotomies with NeoPUTTY
Other interventionPrimary molar pulpotomies will be performed by trained dentists using NeoPUTTY, a ready to use bioactive material containing calcium silicate. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess success rate, and clinical and radiographic outcomes
Treatment groups
Trial outcomes
Primary outcomes
Success rate of a primary molar pulpotomy
A retained primary molar that is void of signs and symptoms of infection such as pain on percussion, mobility, presence of a fistula, or an abscess
Radiographic success of a primary molar pulpotomy
Absence of pathologic changes such as internal or external root resorption, or a periradicular pathosis.
Locations
Sponsors and contacts
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