Evaluation of Success of Complete Pulpotomy With Biodentine on Mature Permanent Single Rooted Teeth With Symptomatic Irreversible Pulpitis

This study aims to evaluate the clinical success of complete pulpotomy using Biodentine in mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis. Complete pulpotomy involves removal of the coronal pulp and preservation of radicular pulp vitality using a biocompatible pulp-capping material. Biodentine, a calcium silicate-based cement, has favorable biological properties, including biocompatibility, antibacterial effects, and dentin bridge formation potential. A total of 84 patients meeting the inclusion criteria will be enrolled and treated by a single operator. Clinical success will be evaluated at 7 days, 1 month, and 3 months based on absence of pain, swelling, tenderness to percussion, and radiographic signs of periapical pathology.

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Key information

Conditions

Symptomatic Irreversible Pulpitis

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental hospial, Hitec-IMS

Rawalpindi, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Mature permanent single rooted teeth with:

Symptomatic irreversible pulpitis
Age group 20-50 years

Exclusion criteria

• Uncontrolled pulp heamorrhage (more than 5mins)

Necrotic pulp
Periapical periodontitis
Sinus tract
Abnormal tooth mobility
Single rooted teeth with internal or external root resorption
Calcified root canals

Treatment and study plan

Complete Pulpotomy with Biodentine

Procedure

Administration of local anesthesia followed by rubber dam isolation.

Removal of coronal pulp tissue to perform a complete pulpotomy.

Hemostasis achieved with saline-soaked cotton pellet.

Placement of Biodentine as the pulp-capping agent on the radicular pulp.

Temporary restoration placed immediately after Biodentine placement.

Permanent composite restoration placed after 1 week.

Follow-up visits at 7 days, 1 month, and 3 months for clinical and radiographic evaluation.

Primary outcomes

Success of Complete Pulpotom

Time frame: Evaluated at 7 days, 1 month, and 3 months post-procedure

Clinical assessment of pain, swelling, and tenderness on percussion.

Radiographic evaluation for absence of periapical lesions and root resorption.

Success defined as absence of symptoms and radiographic signs of pathology, indicating maintenance of pulp vitality.

Sponsors and collaborators

Lead sponsor

HITEC-Institute of Medical Sciences

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 8, 2025
Registry last updated: Aug 8, 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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Completed