Irreversible Pulpitis Clinical Trial
Official title:
Comparing the Outcome of Pulpotomy Using Biodentine and Portland Cement in Mature Cases With Irreversible Pulpitis: Randomized Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 64 |
Est. completion date | August 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University |
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. — View Citation
Danesh G, Dammaschke T, Gerth HU, Zandbiglari T, Schäfer 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Post-operative pain | Patients will be contacted by telephone by the same operator to record pain intensity on Numerical Rating Scale (NRS) | 6, 12, 24, 48 hours and 1 week |
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