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

NCT06787742 | Completed Phase 3 DMC

• 1 other identifier: (528/2022)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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:
• 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.
• 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.
• 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+.
• Neither the preoperative pain nor the intraoperative bleeding time within 10 minutes influenced the pulpotomy outcome.
• The concentration of TNF-α and MMP-9 biomarkers directly impact the outcome of pulpotomy.

Conditions

Vital Pulp Therapies; Tooth Defect

Keywords

Biomarkers; Calcium silicate cements; Full pulpotomy; Irreversible pulpitis; Mature teeth

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 pulpotomy 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

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).

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Hemostasis

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Dalia Mukhtar Fayyad, Professor of endodontics

  Suez Canal University

  STUDY CHAIR

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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)

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: September 21, 2022
• Primary Completion: October 1, 2023
• Study Completion: May 1, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

EG (1)