Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04573374
Study type Interventional
Source Cairo University
Contact Aya A Gamal, MSc
Phone 01111078317
Email aya.youssef@dentistry.cu.edu.eg
Status Not yet recruiting
Phase N/A
Start date November 2020
Completion date August 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04585438 - Evaluation of Trans-mucosal Bio-adhesive Discs of Diclofenac Potassium on the Anesthetic Success and Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial Phase 4
Completed NCT02923687 - Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain Phase 2
Completed NCT02614118 - Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain Phase 2
Completed NCT02601911 - Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection Phase 2
Completed NCT01496846 - Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars Phase 4
Withdrawn NCT04040127 - Residual Dental Pulp Tissue and Cord Blood Stem Cells Phase 2
Completed NCT06176378 - A Clinical and Radiographic Evaluation of Low-Level Diode Laser Full Pulpotomy in Vital Permanent Teeth N/A
Recruiting NCT04243733 - MTA vs CEM Pulpotomy in Young Permanent Molars N/A
Recruiting NCT06245161 - Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients N/A
Not yet recruiting NCT06420583 - Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction of Permanent First Molar N/A
Completed NCT05778227 - Comparing Different Single and Combination Chelating Agents on Sealer Penetration and Dentin Erosion. N/A
Completed NCT04654845 - Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis. N/A
Recruiting NCT06142799 - Influence of Moment of Restoration in Pain After a Root Canal Treatment N/A
Active, not recruiting NCT06240130 - Outcome Following Use of NaOCl and Chlorhexidine as Wound Lavage Agents N/A
Recruiting NCT06433245 - Outcome Following Use of Different Concentrations of NaOCl as Wound Lavage and Hemostatic Agent in Partial Pulpotomy N/A
Not yet recruiting NCT06427070 - Effectiveness of Two Intracanal Irrigation Solutions N/A
Not yet recruiting NCT05349929 - Analgesic Effect of Anahil and Ibuprofen on Pain After Root Canal Therapy in Patients With Pulpitis of the Molars in Qazvin(a City in Iran) Phase 2
Recruiting NCT06149845 - Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis N/A
Completed NCT01561183 - Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis N/A
Recruiting NCT06231290 - The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth N/A