Hydraulic Cements in Partial Pulpotomy

NCT06881615 | Completed DMC FDA Device

• 2 other identifiers: 2023-305CI 2023-305
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized clinical trial that compares two types of hydraulic cements used in partial pulpotomy procedures for permanent teeth affected by deep decay and pulp inflammation. The purpose of the study is to determine which cement results in better treatment outcomes, such as preserving tooth vitality, reducing pain, and promoting healing. All patients receive a standardized treatment procedure and are then randomly assigned to one of the two cement groups. Key factors such as the time required to achieve hemostasis, the size of the pulp exposure, and other clinical variables are evaluated. Patients are followed up at 15 days and at 1, 3, 6, and 12 months after treatment to assess their clinical and radiographic outcomes. The results of this study will help improve treatment protocols and guide health care providers in selecting the most effective materials for partial pulpotomy.

Conditions

Pulpitis; Caries Active

Keywords

partial pulpotomy; hydraulic cements; hemostasis

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Clinical Success at 15 days

  Clinical success is defined as the absence of pain, absence of tenderness to percussion, and no sinus tract formation.

  From enrollment to the end of treatment at 2 weeks

• Number of Participants with Clinical Success at 1,3,6 months

  Clinical success is defined as the absence of pain, absence of tenderness to percussion, and no sinus tract formation.

  From enrollment to the end of treatment at 1, 3, 6 months

• Radiographic success

  Number of Participants with Radiographic Success Based on Periapical Index (PAI) at 12 Months. Radiographic success is defined as a Periapical Index (PAI) score ≤ 2, evaluated by two independent endodontists.

  From enrollment to the end of treatment at 1, 3, 6, 12 months

• Number of Participants with Clinical Success at 12 Months

  Clinical success is defined as the absence of pain, absence of tenderness to percussion, and no sinus tract formation.

  participants enrolled from end of the treatment to 12 months

• Mean Pain Score at 15 Days, 1,3,6 and 12 months Using the Numeric Rating Scale (NRS)

  Postoperative pain is assessed using the Numeric Rating Scale (NRS) from 0 to 10, where higher scores indicate greater pain.

  15 days, 1 month, 3 months, 6 months and 12 months post-intervention

Study Arms (2)

MTA

EXPERIMENTAL

MTA PLACEMENT FOR PP

Device: MTA PLACEMENT FOR PP

PUTTY

EXPERIMENTAL

PUTTY PLACEMENT FOR PP

Device: PUTTY PLACEMENT FOR PP

Interventions

MTA PLACEMENT FOR PP DEVICE

MTA PLACEMENT FOR PP

MTA

PUTTY PLACEMENT FOR PP DEVICE

PUTTY PLACEMENT FOR PP

PUTTY

Eligibility Criteria

• Age: 18 Years - 88 Years
• Gender Eligibility Details: male and female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with initial, mild, moderate, or severe pulpitis according to the Wolters et al. (2017) classification (Wolters et al., 2017),
• aged between 18 and 88 years
• having a non-contributory medical history.
• only permanent teeth affected by caries and exhibiting a proximity to the pulp-assessed via periapical and bitewing radiographs-with a distance ranging from 0 to 1.5 mm
• required to have fully formed apices,
• a periapical index score of ≤2,
• no tenderness on percussion
• probing pocket depths and mobility within normal limits.

You may not qualify if:

• patients diagnosed with pulp necrosis according to the American Association of Endodontists (AAE) guidelines("AAE Consensus Conference Recommended Diagnostic Terminology," 2009);
• patients who declined vital pulp therapy as a treatment option;
• patients with systemic conditions that could affect treatment outcomes.
• teeth were excluded if they exhibited immature roots;
• if no pulp exposure occurred despite complete caries excavation;
• if bleeding after pulpal amputation could not be controlled within the prescribed time (10 minutes)(Taha et al., 2017)

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Clinica Odontologica Universitaria Universidad Europea de Madrid

Madrid, Madrid, 28045, Spain

Location

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 18, 2025
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 22, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)