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

NCT04573374 | Unknown DMC

• 1 other identifier: CEBD-CU-2020-09-17
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Irreversible Pulpitis

Keywords

irreversible pulpitis; pulpotomy; Biodentine; Portland cement

Outcome Measures

Primary Outcomes (3)

• Pulpotomy Success rate

  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.

  3 months

• Pulpotomy success rate

  Clinical and radiographic evaluation is scheduled at 6 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.

  6 months

• Pulpotomy success rate

  Clinical and radiographic evaluation is scheduled at 12 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.

  12 months

Secondary Outcomes (1)

• Post-operative pain

  6, 12, 24, 48 hours and 1 week

Study Arms (2)

Biodentine

ACTIVE COMPARATOR

Biodentine (BD; Septodont, St Maur-des-Fosses, France) is a calcium silicate capping material. 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.

Procedure: Pulpotomy

Portland cement

ACTIVE COMPARATOR

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

Procedure: Pulpotomy

Interventions

Pulpotomy PROCEDURE

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

Also known as: Vital pulp therapy

Biodentine; Portland cement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exposed permanent teeth with mature roots.
• Asymptomatic irreversible pulpitis (no or mild symptoms) and Symptomatic irreversible pulpitis {spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (interpreted as lingering pain)} compared to contralateral normal teeth, and which could be reproduced using cold testing.
• Pre-operative pain assessed as none (but clinically exposed), moderate or severe on Numerical Rating Scale (NRS).
• The tooth is restorable and free from advanced periodontal disease.
• Soft tissues around the tooth are normal with no swelling or sinus tract.
• Vital bleeding pulp tissue should be present in all canals after pulpotomy.
• Age: more than 18 years

You may not qualify if:

• Immature teeth.
• Necrotic pulp and absence of bleeding upon exposure.
• Teeth unresponsive to cold stimulation, presence of sinus tracts or swelling, presence of periapical rarefaction, internal or external root resorption or root canal calcification on radiograph.
• Non-restorable teeth or teeth indicated for post and core restoration
• Teeth with severe periodontal disease.
• Any serious medical problem that prevented the patient from receiving treatment or attending follow-up visits. Pregnant or lactating female patients.
• Patients who used long-acting Non-steroidal anti-inflammatory drugs (NSAIDs) before treatment.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.

  PMID: 30292451 BACKGROUND

• Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11.

  PMID: 30981748 BACKGROUND

• Danesh G, Dammaschke T, Gerth HU, Zandbiglari T, Schafer E. A comparative study of selected properties of ProRoot mineral trioxide aggregate and two Portland cements. Int Endod J. 2006 Mar;39(3):213-9. doi: 10.1111/j.1365-2591.2006.01076.x.

  PMID: 16507075 BACKGROUND

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Aya A Gamal, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya A Gamal, MSc

CONTACT

01111078317; aya.youssef@dentistry.cu.edu.eg

Ghada Eid, phD

CONTACT

ghada.eid@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 5, 2020
• Study Start: November 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share