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

NCT ID: NCT06787742

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2024-05-01

Brief Summary

The present study aimed to evaluate and compare the clinical and radiographic outcomes of full pulpotomy in mandibular molar teeth with symptomatic irreversible pulpitis according to:

A. Number of tooth surfaces defects:

• Class I cavity defect.
• Class II cavity defect.

B. Using two types of pulpotomy dressing materials:

• MTA+ (Cerkamed, Stalowa, Poland).
• Well-Root PT (Vericom, Gangwon-Do, Korea). And.,

To correlate this outcome to the quantification of two biomolecules:

• Tumor necrosis factor-alpha (TNF-⍺).
• Matrix metalloproteinases-9 (MMP-9).

Based on the results of the present study, it was concluded that:

1. Full pulpotomy using calcium silicate cements (CSCs) is considered a conservative, economical, and simple treatment option with a favorable prognosis for teeth with symptomatic irreversible pulpitis.

2. Class I and class II cavity defects do not adversely affect pulpotomy prognosis taking into consideration good aseptic condition, magnification, and proper seal of filling materials.

3. Although MTA+ and Well-Root PT yielded similar outcomes for pulpotomy in terms of success rates. Well-root PT is easier to handle compared to MTA+ and doesn't have a discoloration effect which is considered one of the drawbacks associated with MTA+.

4. Neither the preoperative pain nor the intraoperative bleeding time within 10 minutes influenced the pulpotomy outcome.

5. The concentration of TNF-α and MMP-9 biomarkers directly impact the outcome of pulpotomy.

Detailed Description

The current study addresses an important gap in research, as the impact of cavity configuration on the outcomes of full pulpotomy has not been well explored. Comparing Class I and Class II cavity defects in this context can provide valuable insights, especially given the differences in structural integrity, bacterial infiltration risks, and restorative challenges associated with these defects.

Conditions

Vital Pulp Therapies; Tooth Defect

Study Design

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

Study Groups

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

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)

Group Type: ACTIVE_COMPARATOR

full pulpotomy

Intervention Type: PROCEDURE

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

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

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).

Group Type: ACTIVE_COMPARATOR

full pulpotomy

Intervention Type: PROCEDURE

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

Interventions

full pulpotomy

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

Intervention Type: PROCEDURE

Other Intervention Names

collecting pulpal blood samples; Hemostasis; pulpotomy dressing materials; final restoration

Eligibility Criteria

Inclusion Criteria

• Mandibular molar teeth with signs and symptoms of symptomatic irreversible pulpitis without radiographic evidence of apical periodontitis.
• Age range of 21-45 years old.
• Males or females.
• No disabilities.
• Class I and/or class II cavity defects.
• Teeth reveal positive response to cold tests.

Exclusion Criteria

• Presence of open apices.
• Non-restorable teeth.
• Teeth in which the pulpal bleeding time is more than 10 minutes.
• Presence of large carious lesions approaching the root.
• Presence of calcification or resorption.
• Periodontally affected teeth.
• Patients who are taking antibiotics within one week before treatment.
• Patients consumed taking analgesics within 24 hours before treatment.
• Systemically compromised patients.
• Pregnant females.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dalia Mukhtar Fayyad, Professor of endodontics

Role: STUDY_CHAIR

Suez Canal University

Locations

Faculty of Dentistry, Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

(528/2022)

Identifier Type: -

Identifier Source: org_study_id