Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID07375576

Evaluation of Total Pulpotomy, Radicular Pulpotomy, and Root Canal Treatment Outcomes in Teeth with Extremely Deep Caries and Symptomatic Irreversible Pulpitis

Led by Mustafa Kemal University · Updated on 2026-06-05

99

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical effectiveness of total pulpotomy, radicular pulpotomy, and root canal treatment in mandibular premolar and molar teeth diagnosed with symptomatic irreversible pulpitis. The study aims to compare these treatments in terms of postoperative pain control and treatment success over time. A total of 99 teeth will be included and randomly assigned to one of the three treatment groups to assess outcomes using standardized protocols. The study involves three treatment groups: total pulpotomy, radicular pulpotomy, and root canal treatment. Total pulpotomy consists of removing the coronal pulp and applying mineral trioxide aggregate (MTA) after achieving hemostasis. Radicular pulpotomy involves removing pulp tissue a few millimeters below the canal orifices, followed by MTA application. Root canal treatment includes cleaning and shaping of the root canals with irrigation and obturation using a calcium silicate-based sealer. All treated teeth will receive a final restoration with glass ionomer cement and composite resin. Participants will receive local anesthesia and undergo treatment according to their assigned group. Postoperative pain will be recorded using a visual analog scale at specified times up to 7 days after treatment. Clinical and radiographic evaluations to assess treatment success and periapical health will occur at 3, 6, and 12 months. Additional assessments include restorative integrity and pulp sensibility testing. Patients will be monitored for up to one year, with measures of pain and healing recorded as primary outcomes.

CONDITIONS

Brief Title

Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy patients aged between 15 and 45 years
  • Both sexes are eligible
  • Restorable, extremely deep carious lesions in mandibular first or second molars, and first or second premolars
  • Healthy periodontal status with pocket depth of 3 mm or less
  • Clinical diagnosis of symptomatic irreversible pulpitis with history of spontaneous pain, prolonged cold sensitivity, and positive electric pulp test
Not Eligible

You will not qualify if you...

  • Teeth with cracks or cusp fractures
  • Teeth with subgingival caries
  • Teeth with periapical radiolucency
  • Patients without informed consent

AI-Screening

AI-Powered Screening

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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 treatment visit

Participants receive one of three dental treatments: total pulpotomy, radicular pulpotomy, or root canal treatment. Procedures include local anesthesia, caries removal, pulp tissue removal or root canal instrumentation, application of materials for pulp protection or canal obturation, and final tooth restoration. Postoperative pain management instructions are provided.

1 visit (in-person)

Follow-up

Duration - Up to 12 months

Participants return for clinical and radiographic evaluations at 3, 6, and 12 months to assess treatment success, including pain assessment, pulp sensibility tests, and restorative integrity checks. Additional visits may occur earlier if symptoms arise.

3 visits (in-person) at 3, 6, and 12 months, with additional visits as needed

Trial Site Locations

Total: 1 location

1

Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University

Hatay, Antakya, Turkey (Türkiye), 31000

Actively Recruiting

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Research Team

E

Efkan Aksay

M

Merve Sarı, DDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction.

Nessrin A Taha, Alaa M Abuzaid, Yousef S Khader

https://pubmed.ncbi.nlm.nih.gov/37080387

The outcome of full and deep pulpotomy in teeth with extremely deep carious lesion and symptomatic irreversible pulpitis: A non-inferiority randomized controlled trial.

Aaqib Shah, Amritha Pv, Sidhartha Sharma...

https://pubmed.ncbi.nlm.nih.gov/39887741

Periradicular status and quality of root canal fillings and coronal restorations in an urban Colombian population.

Jaime O Moreno, Flávio R F Alves, Lúcio S Gonçalves...

https://pubmed.ncbi.nlm.nih.gov/23611376

Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial.

Mohit Galani, Sanjay Tewari, Pankaj Sangwan...

https://pubmed.ncbi.nlm.nih.gov/29061359

European Society of Endodontology position statement: Management of deep caries and the exposed pulp.

European Society of Endodontology (ESE) developed by:, H F Duncan, K M Galler...

https://pubmed.ncbi.nlm.nih.gov/30664240

A macroscopic and histological analysis of radiographically well-defined deep and extremely deep carious lesions: carious lesion characteristics as indicators of the level of bacterial penetration and pulp response.

S Demant, S Dabelsteen, L Bjørndal

https://pubmed.ncbi.nlm.nih.gov/33012046