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

Clinical and Radiographic Evaluation of Partial Pulpotomy Versus Complete Pulpotomy in Vital Pulp Therapy in Primary Molars Using NeoPUTTY™ (MTA): Randomized Clinical Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pulp Disease, Dental
• Intervention / Treatment: Procedure: Partial Pulpotomy; Procedure: Complete pulpotomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yara A. Badr, Masters; Phone Number: +201001151170; Email: yara.badr@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Complete pulpotomy	Procedure: Complete pulpotomy; After removing caries with a large round bur, the access cavity will be opened. Excavation of inflamed coronal pulp tissues will be done using a sharp excavator. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.
Experimental: Partial Pulpotomy	Procedure: Partial Pulpotomy; After removing caries high-speed handpiece with water coolant using a round diamond bur. Once there is an exposure, the bur is changed with another sterile one with which the superficially inflamed pulp tissue will be gently removed to a depth of 1-3 mm beneath the pinpoint pulp exposure that occurred at the end of caries removal. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic success	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.	0, 6, 12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hany M. Saber, PHD, Faculty of Dental Medicine, Cairo University; Study Director: Hanaa M. Abd El Moniem, PHD, Faculty of Dental Medicine, Cairo University; Principal Investigator: Yara A. Badr, Masters, Faculty of Dental Medicine, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 22, 2024
• Primary Completion (Estimated): December 22, 2024
• Study Completion (Estimated): December 22, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Tooth Diseases; Dental Pulp Diseases; Stomatognathic Diseases
• Other Study ID Numbers: 28052024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No