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

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

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.

Study Overview

• Status: Completed
• Conditions: Vital Pulp Therapies; Tooth Defect
• Intervention / Treatment: Procedure: full 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Faculty of Dentistry, Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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; Other Names: Hemostasis; collecting pulpal blood samples; pulpotomy dressing materials; final restoration
Active Comparator: 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).	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; Other Names: Hemostasis; collecting pulpal blood samples; pulpotomy dressing materials; final restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Chair: Dalia Mukhtar Fayyad, Professor of endodontics, Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Biomarkers; Irreversible pulpitis; Mature teeth; Full pulpotomy; Calcium silicate cements
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia; Coagulants; Hemostatics
• Other Study ID Numbers: (528/2022)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No