NCT06787742

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

Assessment of the Number of Missing Tooth Surfaces and a New Bioceramic Material on the Outcomes of Vital Pulp Therapy: A Randomized Clinical Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2022-09-21
• Primary completion: 2023-10-01
• Completion: 2024-05-01
• First posted: 2025-01-22
• Last updated: 2025-06-05

Locations

1 site across 1 country: Egypt