Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material

July 14, 2024 updated by: Mahmoud Yahia Ramadan Abdelsalam, Al-Azhar University

Evaluation Of The Efficacy Of Using Calcium-Silicate Based Sealers As A Pulp Capping Material After Adult Pulpotomy: An In-vivo Study

This clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. The study will evaluate both the clinical and radiographic changes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Root canal treatment has always been considered the first line of treatment for carious teeth with symptomatic irreversible pulpitis for a long time. However, after the evolution of calcium silicate based materials a more conservative option, which is pulpotomy began to gain reliability, especially that it preserves the vitality of the radicular pulp, clinically simpler, less time-consuming, and more cost-effective compared to conventional root canal treatment.

In this study the investigators assess the clinical and radiographic success rate of using calcium silicate based sealer as a pulp capping material in permanent molars after pulpotomy.

For the best of the investigators' knowledge, there is no available clinical data on the use of calcium-silicate based sealers as a pulp capping material in pulpotomy of permanent molars with symptoms of irreversible pulpitis.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11651
        • Faculty of Dental Medicine, Al-Azhar University
        • Principal Investigator:
          • Mahmoud Y Abdelsalam, Master Degree
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Vital mandibular molar teeth with mature apices.
  • Teeth that respond positively to cold testing.
  • Teeth without any signs of necrosis including sinus tract or swelling.
  • Teeth with caries extending ≥ 2/3 of dentine or exposing the pulp.
  • Teeth with symptomatic irreversible pulpitis with/without apical periodontitis.
  • Teeth without periodontal diseases or mobility.
  • Teeth without root resorption, detectable pulp chamber and root canal calcification or history of trauma.
  • Patients from both genders with age range from 20 to 45 years old.
  • Patients with good or moderate oral hygiene and without any systemic diseases.

Exclusion Criteria:

Pre-operative criteria:

  • Non-vital teeth.
  • Teeth with irreversible pulpitis with apical periodontitis.
  • Teeth with immature apices.
  • Teeth with Periodontal disease or mobility grade II or III.
  • Teeth that are badly decayed and need post and core placement.
  • Patients refused to continue treatment procedures or refuse to commit to periodic follow-up sessions.
  • Non-restorable teeth.

Intra-operative criteria:

  • If hemostasis could not be achieved within 6 minutes after full pulpotomy.
  • Teeth with partial necrosis.
  • No bleeding after access cavity preparation.

Post-operative criteria:

  • presence of Swelling.
  • presence of Sinus tract.
  • Pain on percussion after the end of the first week.
  • Pain with palpation.
  • Pain on biting after the end of first week.
  • Mobility of the tooth.
  • Fracture of tooth structure that renders the tooth non-restorable.
  • Fracture of the restoration during the evaluation.
  • Probing depth more than 3 mm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: calcium silicate-based sealer
Performing full pulpotomy of permanent mandibular and maxillary molar teeth using calcium silicate-based sealer as a capping agent.
Procedure: Calcium silicate-based sealer full Pulpotomy
Using calcium silicate-based sealer as a capping agent after full pulpotomy
Active Comparator: Premixed calcium silicate-based putty
Performing full pulpotomy of permanent mandibular and maxillary molar teeth using premixed calcium silicate-based putty as a capping agent.
Procedure: Calcium silicate-based premixed putty full Pulpotomy
Using calcium silicate-based premixed putty as a capping agent after full pulpotomy
Experimental: combination between calcium silicate-based sealer and premixed calcium silicate-based putty
Performing full pulpotomy of permanent mandibular and maxillary molar teeth using a combination of calcium silicate-based sealer and premixed calcium silicate-based putty as a capping agent.
Procedure: Full Pulpotomy
Using combination between calcium silicate-based sealer and calcium silicate-based premixed putty as a capping agent after full pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success after full pulpotomy procedure
Time Frame: immediate postoperative
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
immediate postoperative
Radiographic success after full pulpotomy procedure
Time Frame: immediate postoperative
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
immediate postoperative
Clinical success after full pulpotomy procedure
Time Frame: At 1 month
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling, absence of sinus tract or fistula and absence of tooth mobility.
At 1 month
Cinical success after full pulpotomy procedure
Time Frame: At 3 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
At 3 months
Clinical success after full pulpotomy procedure
Time Frame: At 6 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
At 6 months
Radiographic success after full pulpotomy procedure
Time Frame: At 6 months
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
At 6 months
Clinical success after full pulpotomy procedure
Time Frame: At 9 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
At 9 months
Clinical success after full pulpotomy procedure
Time Frame: At 12 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
At 12 months
Radiographic success after full pulpotomy procedure
Time Frame: At 12 months
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Post-operative pain after full pulpotomy procedure
Time Frame: 6 hours, 24 hours, 48 hours, 72 hours and 7 days
The postoperative pain was assessed by using the modified verbal descriptor Scale (mVDS). Patients were instructed to place a mark on the horizontal scale to represent the intensity of pain experienced, furthermore, they were asked to use the verbal descriptors as a guide. The level of pain was documented at the range of 0-10 numerically and verbally as no pain (0), slight pain (1, 2), moderate pain (3-5), strong pain (6, 7), severe pain (8), and maximum pain (9, 10).
6 hours, 24 hours, 48 hours, 72 hours and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Study Chair: Moataz A Elkhawas, PhD, Faculty of Dental Medicine, Al-Azhar University, Cairo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 14, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 959/1498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

I am planning to share the study protocol and clinical study report

IPD Sharing Time Frame

Once I get the Results

IPD Sharing Access Criteria

Full access to the selected data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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