Clinical trial NCT05681494: Assessment of Pain and Treatment Success After VPT Versus RCT in Mature Permanent Mandibular Molars With SIP: A RCT
Official title: Assessment of Postoperative Pain and Treatment Success After Vital Pulp Therapy Versus Root Canal Treatment in Mature Permanent Mandibular Molars With Irreversible Pulpitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Keywords: SIP
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of postoperative pain and treatment success after vital pulp therapy versus root canal treatment in mandibular molar with signs and symptoms of irreversible pulpitis. the null hypothesis, there is no difference will be observed in the pain level and treatment success between two treatments.

Detailed description: After proper clinical and radiographic examination. Teeth will be anesthetized and isolated using a rubber dam. The operative field will be disinfected. Total caries removal will be done from outside making margin caries free to inside. the new diamond bur will be used to remove the last layer and exposed the pulp tissue. Exposed pulp will be inspected under a dental operating microscope and hemostasis will be obtained. The teeth will be randomized into 2 intervention groups (VPT or RCT). Treatment will be finalized, and teeth will be restored with resin-modified glass ionomer followed by composite resin at the same appointment. Ibuprofen 400mg will be prescribed to the patient if needed. Patients will be asked to record postoperative pain after treatment on the pain score sheet.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients.
* Patient's age range more than 15 years.
* Mature permanent mandibular molars with deep caries.
* Clinical diagnosis of symptomatic irreversible pulpitis.
* Teeth with no need for the post.
* Healthy periodontium and mobility within normal limits.
* Patients who can understand the pain scale and can sign the informed consent

Exclusion Criteria:

* Teeth with a negative response to vitality testing.
* Teeth with furcal bone loss.
* Teeth with sinus tract
* Teeth with swelling.
* Teeth with a non-restorable crown.
* Teeth with immature roots.
* Teeth with no pulp exposure even after caries excavation.
* History of analgesic intake in the previous week.
* History of antibiotic intake in the previous month.
* Insufficient bleeding after pulp exposure suggestive of partial necrosis of the pulp.
* Inability to control bleeding within 10 min.
* Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Primary outcomes:
measure: Postoperative pain
timeFrame: at 6 hours postoperative
Secondary outcomes:
measure: Intensity of postoperative pain
timeFrame: at 24, 48 hours and 7 days
measure: Treatment success
timeFrame: at 3,6,12 months
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer, Department of Endodontics, Faculty of Dentistry, Cairo university.
name: Ahmed S Elsheshtawy
role: STUDY_DIRECTOR
References:
citation: Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
citation: Santos JM, Pereira JF, Marques A, Sequeira DB, Friedman S. Vital Pulp Therapy in Permanent Mature Posterior Teeth with Symptomatic Irreversible Pulpitis: A Systematic Review of Treatment Outcomes. Medicina (Kaunas). 2021 Jun 3;57(6):573. doi: 10.3390/medicina57060573.
citation: Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod. 2022 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24.
citation: Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.