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

NCT ID: NCT06524076

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-22
• Study Completion Date: 2025-12-22

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.

Conditions

Pulp Disease, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Partial Pulpotomy

Group Type: EXPERIMENTAL

Partial Pulpotomy

Intervention Type: PROCEDURE

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.

Complete pulpotomy

Group Type: ACTIVE_COMPARATOR

Complete pulpotomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yara Ayman

Internal resident of Pediatric Dentistry and Public Health, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany M. Saber, PHD

Role: STUDY_CHAIR

Faculty of Dental Medicine, Cairo University

Hanaa M. Abd El Moniem, PHD

Role: STUDY_DIRECTOR

Faculty of Dental Medicine, Cairo University

Yara A. Badr, Masters

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dental Medicine, Cairo University

Central Contacts

Yara A. Badr, Masters

Role: CONTACT

yara.badr@dentistry.cu.edu.eg

+201001151170

Other Identifiers

28052024

Identifier Type: -

Identifier Source: org_study_id