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Outcome Measures

Primary Outcomes (2)

success/failure
Treatment was considered successful (healed) according to Zanini et al. (2016) based on the following criteria: (Clinically) absence of signs and symptoms of pulpal pathosis, no history of spontaneous pain or discomfort on chewing, no tenderness to percussion/palpation, no soft tissue swelling, fistula, or abnormal mobility. (Radiographically) absence of periapical rarefaction (normal width of periodontal ligament space and normal appearance of the lamina dura), internal or external resorption, and absence of root canal calcification
Patients were scheduled for follow-up appointments (one week, 3, 6, and 12 months)
Pain assessment
Pre-treatment, the patients were instructed on how to fill out a visual analog scale VAS to determine their pain score. Postoperative pain was recorded by the patient every 24 hours in the evening for 7 days. The VAS included scores from 0 to 10, which were further categorized as no pain (0), mild (1-3), moderate (4-6), severe (7-9), or severe intolerable (10).
every 24 hours in the evening for 7 days

Study Arms (2)

A. Number of tooth surfaces defects: • Class I cavity defect. • Class II cavity defect.

ACTIVE COMPARATOR

The selected patients were divided into two groups according to the number of tooth surfaces defects (n=30) (30 with class I and 30 with class II cavity defects)

Procedure: full pulpotomy

pulpotomy dressing materials: • MTA+ (Cerkamed, Poland). • Well-Root (Vericom, Korea).

ACTIVE COMPARATOR

Each group was randomly further subdivided using Microsoft Excel into two subgroups according to the dressing materials, without informing the patients which type of material was used (n=15).

Procedure: full pulpotomy

Interventions

full pulpotomyProcedure

access to dental pulp chamber under aseptic condition, collect blood sample using a micropipette for ELIZA test, stop bleeding using sodium hypochlorite 2.5%, pulpotomy dressing material over pulp stump and final restoration with resign modified glass ionomer and composite resign

Also known as: collecting pulpal blood samples, Hemostasis, pulpotomy dressing materials, final restoration

A. Number of tooth surfaces defects: • Class I cavity defect. • Class II cavity defect.pulpotomy dressing materials: • MTA+ (Cerkamed, Poland). • Well-Root (Vericom, Korea).

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Masking Details

did not inform the patients which type of material was used, All laboratory procedures were performed by a single, experienced individual specializing in biochemical assays, without informing the biochemist of any outcome data of pulpotomy

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: A comparative, randomized, prospective clinical study was utilized for the investigation of the outcome of pulpotomy in the treatment of adult permanent mandibular molar teeth with symptomatic irreversible pulpitis in class I and class II cavity defects using two types of hydraulic calcium silicate cement (MTA+) and (Well-root PT)

Sponsor Type

OTHER

Responsible Party

SPONSOR

Assessment of the Number of Missing Tooth Surfaces and the Molecular Findings on the Outcomes of Vital Pulp Therapy Using Two Calcium Silicate Materials

Brief Summary

Registry Overview

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Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

A. Number of tooth surfaces defects: • Class I cavity defect. • Class II cavity defect.

pulpotomy dressing materials: • MTA+ (Cerkamed, Poland). • Well-Root (Vericom, Korea).

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

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Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

A. Number of tooth surfaces defects: • Class I cavity defect. • Class II cavity defect.

pulpotomy dressing materials: • MTA+ (Cerkamed, Poland). • Well-Root (Vericom, Korea).

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations