Clinical trial 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
Official title: Assessment of the Number of Missing Tooth Surfaces and a New Bioceramic Material on the Outcomes of Vital Pulp Therapy: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vital Pulp Therapies
Tooth Defect
Keywords: Biomarkers
Calcium silicate cements
Full pulpotomy
Irreversible pulpitis
Mature teeth
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: success/failure
timeFrame: Patients were scheduled for follow-up appointments (one week, 3, 6, and 12 months)
measure: Pain assessment
timeFrame: every 24 hours in the evening for 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Faculty of Dentistry, Suez Canal University
Study officials:
affiliation: Suez Canal University
name: Dalia Mukhtar Fayyad, Professor of endodontics
role: STUDY_CHAIR
References: