Clinical trial NCT06488131: Comparing MTA Pulpotomy to Root Canal Treatment in Management of Permanent Molars With Irreversible Pulpitis in Children
Official title: A Comparative Study Between MTA Pulpotomy and Root Canal Treatment in Management of First Permanent Molars With Irreversible Pulpitis in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Irreversible Pulpitis
Keywords: Endodontic Treatment, Vital Pulp Therapy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 62
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental caries, highly prevalent amongst children, can cause pulpitis. Coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis.

The aim of the current study is to evaluate postoperative pain, clinical and radiographic outcomes of MTA pulpotomy compared to root canal treatment in children's first permanent molars suffering from irreversible pulpitis.

Detailed description: In this randomized controlled trial, patients aged 10-14 years suffering from irreversible pulpitis in the first permanent molar with closed apex will be randomly divided into two groups. The first group will receive complete coronal MTA pulpotomy, while the second group will receive endodontic treatment.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female children, aged 10 to 14 years
* Signs and symptoms of irreversible pulpitis in carious first permanent molar.

Exclusion Criteria:

* Molars with immature roots
* Non-restorable molars, with abnormal mobility or increased probing pocket depth (normal range = 1-3 mm)
* Any indication of pulpal necrosis, such as sinus tract or swelling or no bleeding from orifices after access opening.
* Any signs of periapical or furcal rarefaction.

Primary outcomes:
measure: Pain Relief
timeFrame: preoperatively, immediately postoperatively and every 24 hours for 7 days after the first appointment.
Secondary outcomes:
measure: Clinical Evaluation
timeFrame: 3, 6, 12 and 18 months postoperatively
measure: Radiographic Evaluation
timeFrame: 6, 12 and 18 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Dentistry, Ain Shams University, Cairo, Egypt
name: Alaa A. Eissa, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
citation: Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.
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.
citation: Beauquis J, Setbon HM, Dassargues C, Carsin P, Aryanpour S, Van Nieuwenhuysen JP, Leprince JG. Short-Term Pain Evolution and Treatment Success of Pulpotomy as Irreversible Pulpitis Permanent Treatment: A Non-Randomized Clinical Study. J Clin Med. 2022 Jan 31;11(3):787. doi: 10.3390/jcm11030787.