Direct Pulp Capping Versus Pulpotomy for Primary Molars

NCT06973057 | Enrolling By Invitation

• 1 other identifier: 341-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries is one of the most prevalent chronic diseases worldwide. Interventions for treating deep carious lesions in teeth with no history of pain or teeth with reversible pulpitis are referred to as vital pulp therapy; these include indirect pulp treatment (IPC), direct pulp capping (DPC), and pulpotomy. Pulpotomy is considered invasive when treating exposed primary vital pulps due to caries. Less invasive vital pulp treatment methods such as DPC might, therefore, be preferable, as they reduce chair time, less tooth structure removal and a crown might not always be a necessary permanent restoration. The aim of this clinical study is to evaluate the clinical and radiographic outcomes of DPC when compared to pulpotomy in primary molars with carious pulp exposure.

Conditions

Vital Pulp Therapies

Keywords

Vital Pulp therapies; Direct pulp capping; Pulpotomy; Neo MTA; Primary molars; Randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• Clinical success

  No post-treatment signs or symptoms such as sensitivity, pain, mobility or swelling should be evident.

  24 months

• Radiographic success

  No radiographic evidence of pathologic external or internal root resorption, periapical or furcation radiolucency.

  24 months

Study Arms (2)

Pulpotomy

ACTIVE COMPARATOR

The entire coronal pulp will be amputated.

Procedure: Pulpotomy

Direct pulp capping

ACTIVE COMPARATOR

The exposure site will be left intact, no amputation of pulp tissue.

Procedure: Direct pulp capping (DPC)

Interventions

Pulpotomy PROCEDURE

The entire coronal pulp will be amputated to the level of canal orifices, after hemostasis, NeoMTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.

Pulpotomy

Direct pulp capping (DPC) PROCEDURE

At the exposure site hemostasis will be achieved, neo MTA will be placed, then tooth will be restored with glass ionomer cement, and the tooth will be subsequently restored with a crown.

Direct pulp capping

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy patients.
• Age 4-10 years.
• Primary molar with deep caries present bilaterally.
• Teeth should be restorable.
• Clinically normal asymptomatic tooth or symptoms of reversible pulpitis (No history of pain or provoked pain subsides upon removal of the stimulus).
• Radiographically: caries in the inner half of the dentin approaching the pulp.

You may not qualify if:

• History of spontaneous pain.
• Soft and hard tissue pathology.
• Mobility or exfoliating tooth.
• No pulp exposure after caries excavation.
• Inability to achieve hemostasis after 6 minutes.
• Radiographically: Root resorption exceeding 1/3 of the root, apical pathology.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan Univeristy of Science and Technology

Irbid, 22110, Jordan

Location

Related Publications (5)

• Dimitraki D, Papageorgiou SN, Kotsanos N. Direct pulp capping versus pulpotomy with MTA for carious primary molars: a randomised clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):431-440. doi: 10.1007/s40368-019-00419-7. Epub 2019 Feb 20.

  PMID: 30788777 RESULT

• Alsanouni M, Bawazir OA. A Randomized Clinical Trial of NeoMTA Plus in Primary Molar Pulpotomies. Pediatr Dent. 2019 Mar 15;41(2):107-111.

  PMID: 30992107 RESULT

• ElSebaai A, Wahba AH, Grawish ME, Elkalla IH. Calcium Hydroxide Paste, Mineral Trioxide Aggregate, and Formocresol as Direct Pulp Capping Agents in Primary Molars: A Randomized Controlled Clinical Trial. Pediatr Dent. 2022 Nov 15;44(6):411-417.

  PMID: 36947754 RESULT

• Chatzidimitriou K, Vadiakas G, Koletsi D. Direct pulp capping in asymptomatic carious primary molars using three different pulp capping materials: a prospective clinical trial. Eur Arch Paediatr Dent. 2022 Oct;23(5):803-811. doi: 10.1007/s40368-022-00720-y. Epub 2022 Jul 2.

  PMID: 35780237 RESULT

• Canoglu E, Gungor HC, Uysal S. Direct Pulp Capping of Primary Molars with Calcium Hydroxide or MTA Following Hemorrhage Control with Different Medicaments: Randomized Clinical Trial. Pediatr Dent. 2022 May 15;44(3):167-173.

  PMID: 35799339 RESULT

Related Links

• Pulp Therapy for Primary and Immature Permanent Teeth

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• OLA Al-Batayneh

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A split mouth randomized clinical trial

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)