NCT04573374

Comparing the Outcome of Pulpotomy Using Biodentine and Portland Cement in Mature Cases With Irreversible Pulpitis: Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to compare the treatment outcome of pulpotomy using Biodentine or Portland cement regarding success rate and post-operative pain.

Detailed description

* Patients will be screened for eligibility through obtaining medical and dental histories together with clinical \[visual, palpation, percussion, cold sensitivity testing and probing\] and radiographic evaluations for the teeth. * After ensuring eligibilty, profound local anesthesia of the tooth will be achieved using 4% Articaine with 1: 100000 epinephrine (Septodont. Saint-Maur-des-Fosses. France). * Caries will be removed using a round, high-speed bur with adequate water cooling. * Cases will be randomly divided into two groups according to pulpotomy material either: Biodentine or Portland cement. Biodentine is mixed according to manufacturer's instructions and placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser. Initial setting is achieved after 12 minutes. Preparation of Portland cement: Industrial Portland cement is mixed with Bisthmus oxide or Barium sulphate radio-opacifier in a 3:1 ratio. The mix is sieved through silk sieve then sterilized in hot air oven at 135 ֯C for 2 hours. Portland cement is mixed in a 3:1 powder: distilled water ratio and placed in the pulp chamber and condensed against a moist cotton pellet. A small cotton pellet moistened with saline is placed in the pulp chamber against PC for 5 seconds to ensure water uptake then removed. * Appropriate interim restoration will be done and checked throughout follow up period. Patients will be referred for final restoration after endpoint of research. A post-operative periapical radiograph is taken after interim restoration placement. * Patients will be contacted by telephone by the same operator to record pain intensity (at 6, 12, 24, 48 and after 7 days). * Clinical and radiographic evaluation is scheduled at 3 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.

Conditions

• Irreversible Pulpitis

Interventions

Type	Name	Description
PROCEDURE	Pulpotomy	Pulpotomy is the term for removal of the coronal pulp with the intent of maintaining the vitality of the remaining radicular pulp tissue.

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-06-01
• Completion: 2022-08-01
• First posted: 2020-10-05
• Last updated: 2020-10-05