Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-10
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Primary molars pulpotomies with NeoMTA

    Other intervention

    Primary 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 intervention

    Primary 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

50 Participants
are divided into 2 treatment groups
Group A: NeoMTAActive comparator 1 intervention
Group B: NeoPUTTYExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 months
2

Radiographic success of a primary molar pulpotomy

Absence of pathologic changes such as internal or external root resorption, or a periradicular pathosis.

Time frame
24 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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