Clinical trial NCT04573374: Comparing the Outcome of Pulpotomy Using Biodentine and Portland Cement in Mature Cases With Irreversible Pulpitis: Randomized Clinical Trial
Official title: Comparing the Outcome of Pulpotomy Using Biodentine and Portland Cement in Mature Cases With Irreversible Pulpitis: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: irreversible pulpitis
pulpotomy
Biodentine
Portland cement
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pulpotomy Success rate
timeFrame: 3 months
measure: Pulpotomy success rate
timeFrame: 6 months
measure: Pulpotomy success rate
timeFrame: 12 months
Secondary outcomes:
measure: Post-operative pain
timeFrame: 6, 12, 24, 48 hours and 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Aya A Gamal, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.