Comparing MTA Pulpotomy to Root Canal Treatment in Management of Permanent Molars With Irreversible Pulpitis in Children

NCT06488131 | Not Yet Recruiting Phase 4

• 1 other identifier: PED2024-D2
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irreversible Pulpitis

Keywords

Endodontic Treatment, Vital Pulp Therapy

Outcome Measures

Primary Outcomes (1)

• Pain Relief

  A 10 cm visual analogue scale will be used to record pain

  preoperatively, immediately postoperatively and every 24 hours for 7 days after the first appointment.

Secondary Outcomes (2)

• Clinical Evaluation

  3, 6, 12 and 18 months postoperatively

• Radiographic Evaluation

  6, 12 and 18 months postoperatively

Study Arms (2)

MTA Pulpotomy

EXPERIMENTAL

Local anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Coronal pulp tissue will be removed to the level of canal orifices using a sterile, sharp spoon excavator. A cotton pellet dampened with sodium hypochlorite will be applied on canal orifices to achieve hemostasis. This will be followed by MTA application and glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week.

Procedure: MTA Pulpotomy

Root Canal Treatment

ACTIVE COMPARATOR

Local anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Length of the root canal will be obtained using an apex locator. This will be followed by mechanical shaping using files, and irrigation with 2.5 percent sodium hypochlorite, followed by drying of the canals using paper points. Obturation will then be accomplished using gutta percha and sealer. Finally, the tooth will be restored with conventional glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week.

Procedure: Root Canal Treatment

Interventions

MTA Pulpotomy PROCEDURE

Complete coronal MTA pulpotomy.

Also known as: Vital Pulp Therapy

MTA Pulpotomy

Root Canal Treatment PROCEDURE

Conventional root canal treatment.

Also known as: Endodontic Treatment

Root Canal Treatment

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (4)

• 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.

  PMID: 29061359 RESULT

• 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.

  PMID: 37080387 RESULT

• 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.

  PMID: 34854987 RESULT

• 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.

  PMID: 35160239 RESULT

MeSH Terms

Interventions

Endodontics

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Alaa A. Eissa, Msc

  Faculty of Dentistry, Ain Shams University, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa A. Eissa, Msc

CONTACT

00201012036000; alaaeissa@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.