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Completed

NCT Number: 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

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.

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Key information

Conditions

Vital Pulp Therapies Tooth Defect

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: collecting pulpal blood samples, Hemostasis, pulpotomy dressing materials, final restoration

Primary outcomes

  1. success/failure

    Time frame: 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

  2. Pain assessment

    Time frame: every 24 hours in the evening for 7 days

    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).

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study 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

Acronym: VPT

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 22, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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