Evaluation of Success Rate of Partial Pulpotomy Versus Complete Pulpotomy in Primary Molars Using NeoPUTTY MTA

Cairo University (CU)

Status: Not yet enrolling

Conditions: Pulp Disease, Dental

Treatments: Procedure: Partial Pulpotomy; Procedure: Complete pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06524076

28052024

Details and patient eligibility

About

Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Partial Pulpotomy

Experimental group

Treatment:

Procedure: Partial Pulpotomy

Complete pulpotomy

Active Comparator group

Treatment:

Procedure: Complete pulpotomy