Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars

NCT06380296 | Not Yet Recruiting

• 1 other identifier: 2024-10240
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (2)

• 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

  24 months

• Radiographic success of a primary molar pulpotomy

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

  24 months

Study Arms (2)

NeoMTA

ACTIVE COMPARATOR

Trained dentists will perform the primary molar pulpotomy following a standardized protocol. After amputation of the coronal pulp, the pulp chamber will be filled with NeoMTA 2. Tooth will be then restored with an appropriately sized stainless steel crown cemented with a glass ionomer cement at the same visit. Follow-up visits will be scheduled at 1, 6, 12 and 24 months after the procedure to assess the success rate of primary molars pulpotomy.

Other: Primary molars pulpotomies with NeoMTA

NeoPUTTY

EXPERIMENTAL

Trained dentists will perform the primary molar pulpotomy following a standardized protocol. After amputation of the coronal pulp, the pulp chamber will be filled with NeoPUTTY. Tooth will be then restored with an appropriately sized stainless steel crown cemented with a glass ionomer cement at the same visit. Follow-up visits will be scheduled at 1, 6, 12 and 24 months after the procedure to assess the success rate of primary molars pulpotomy.

Other: Primary molar pulpotomies with NeoPUTTY

Interventions

Primary molars pulpotomies with NeoMTA OTHER

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

NeoMTA

Primary molar pulpotomies with NeoPUTTY OTHER

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

NeoPUTTY

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Children who can understand and speak French or English.

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-scientist; Research director

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 23, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share