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

Phase 3

Completed

• Conditions: Vital Pulp Therapies; Tooth Defect

• Registration Number: NCT06787742
• Lead Sponsor: Suez Canal University

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.

Study Timeline

• Study Start: 2022-09-21
• Primary Completion: 2023-10-01
• Study Completion: 2024-05-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-22
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
success/failure	Patients were scheduled for follow-up appointments (one week, 3, 6, and 12 months)	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

Trial Locations

Locations (1)

Faculty of Dentistry, Suez Canal University; 🇪🇬 Ismailia, Egypt