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

NCT ID: NCT06488131

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-06-30

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.

Conditions

Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MTA Pulpotomy

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.

Group Type: EXPERIMENTAL

MTA Pulpotomy

Intervention Type: PROCEDURE

Complete coronal MTA pulpotomy.

Root Canal Treatment

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.

Group Type: ACTIVE_COMPARATOR

Root Canal Treatment

Intervention Type: PROCEDURE

Conventional root canal treatment.

Interventions

MTA Pulpotomy

Complete coronal MTA pulpotomy.

Intervention Type: PROCEDURE

Root Canal Treatment

Conventional root canal treatment.

Intervention Type: PROCEDURE

Other Intervention Names

Vital Pulp Therapy; 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Eissa

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa A. Eissa, Msc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Ain Shams University, Cairo, Egypt

Central Contacts

Alaa A. Eissa, Msc

Role: CONTACT

alaaeissa@dent.asu.edu.eg

00201012036000

References

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.

Reference Type: RESULT

PMID: 29061359 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37080387 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34854987 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35160239 (View on PubMed)

Other Identifiers

PED2024-D2

Identifier Type: -

Identifier Source: org_study_id