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

Not Applicable

Not yet recruiting

• Conditions: Pulp Disease, Dental
• Interventions: Procedure: Partial Pulpotomy; Procedure: Complete pulpotomy

• Registration Number: NCT06524076
• Lead Sponsor: Cairo University

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Study Start: 2024-09-22
• Primary Completion: 2024-12-22
• Study Completion: 2025-12-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partial Pulpotomy	Partial Pulpotomy	-
Complete pulpotomy	Complete pulpotomy	-

Primary Outcome Measures

Name	Time	Method
Mobility	3, 6, 9, 12 months	Assesment of pathological mobility using mobility test.
Swelling/ Fistula	3, 6, 9, 12 months	Assessment of swelling and fistula through visual examination.
Postoperative pain	one week postoperative	Postoperative pain assessment through Visual Analog Scale (the lower the value the better).

Secondary Outcome Measures

Name	Time	Method
Radiographic success	0, 6, 12 months	Radiographic evaluation (Radiolucency at furcation or periapical, internal or external root resorption) through visual interpretation of digital radiograph at 0, 6 and 12 months postoperatively.