Actively Recruiting

Phase Not Applicable
Age: 9Years - 14Years
All Genders
ID07290049

Evaluation of Postoperative Pain After Pulpotomy Using Calcium Silicate Cements in Permanent Molars With and Without Laser Biomodulation: A Randomized Clinical Trial

Led by University of Fujairah · Updated on 2025-12-17

46

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on children and young adolescents aged 9 to 14 years who have a severe toothache caused by an inflamed nerve in a permanent lower back molar, known as symptomatic irreversible pulpitis. The study compares two methods of vital pulp therapy, a less invasive alternative to root canal treatment, aiming to preserve healthy nerve tissue and improve healing and comfort after treatment. The trial is designed as a prospective, triple-blind, randomized controlled study to evaluate postoperative pain and healing outcomes. Participants will undergo a full pulpotomy procedure where the infected part of the nerve is removed, and the remaining healthy tissue is treated. One group will have their tooth sealed with a calcium silicate cement called EndoCem alone, while the other group will receive the same cement after an additional laser biomodulation treatment applied to the nerve tissue. This laser uses a gentle, non-surgical energy meant to stimulate healing and reduce inflammation. Both groups will have their teeth restored after treatment. During the study, participants will record their pain levels using a Visual Analogue Scale at multiple times after the procedure, specifically at 6, 12, 24, and 48 hours. Researchers will also assess clinical and radiographic success at one week and six months following treatment to monitor healing and tooth health. The trial ensures careful monitoring, blinded assessments, and aims to provide evidence on whether adding laser biomodulation improves comfort and recovery after pulpotomy in young patients.

CONDITIONS

Brief Title

Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy

Who Can Participate

Age: 9Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 9 and 14 years
  • Must have a two-rooted mandibular molar tooth
  • The tooth must be diagnosed with symptomatic irreversible pulpitis
  • The tooth must be restorable with a filling or crown
  • The tooth must be periodontally healthy with no mobility
  • The tooth must not be painful to tapping or pressing
  • Patient or guardian must be able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Teeth with immature root tips
  • Teeth that are not restorable due to severe damage or decay
  • Bleeding from the tooth nerve that cannot be controlled within 10 minutes
  • Patients with significant medical conditions complicating dental treatment
  • Teeth with a dead (necrotic) nerve
  • Inability or unwillingness to provide informed consent
  • Individuals from vulnerable groups as defined by the ethics committee

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure day

Participants receive a full pulpotomy procedure on a permanent molar diagnosed with symptomatic irreversible pulpitis. They will either have a calcium silicate cement placed over the pulp tissue or receive additional laser biomodulation before the cement application, followed by a final tooth restoration.

1 visit (in-person)

Follow-up

Duration - Up to 6 months

Participants record their postoperative pain levels at 6, 12, 24, and 48 hours after the procedure. Clinical success is assessed at 1 week and 6 months, and radiographic success is evaluated at 6 months post-treatment.

Pain assessments at 4 time points within 48 hours; clinical visits at 1 week and 6 months

Trial Site Locations

Total: 1 location

1

Dental Clinic, College of Dentistry, Fujairah University

Fujairah, Emirate of Fujairah, United Arab Emirates, 2202

Actively Recruiting

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Research Team

N

Nabeel Ayappali Kalluvalappil, MDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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