Composite Restoration of Class II Cavities in Primary Molars With or Without Pulpotomy. Prospective 24 Month Clinical Trial.

After 24 months:

• Investigation of the success rate of Class II composite resin restorations in primary molars that have undergone pulpotomy.
• Comparison of Class II composite resin restorations in primary molars that have undergone pulpotomy with restorations of the same type in the same patient, in which no pulpotomy has been performed.

The null hypothesis of the study is that there is no statistically significant difference in the success of Class II resin restorations after their placement in primary molars, regardless of whether a pulpotomy has been performed or not.

Study Overview

• Status: Active, not recruiting
• Conditions: Composite Restoration; Primary Tooth Pulpotomy
• Intervention / Treatment: Procedure: Class II restoration after pulpotomy; Procedure: Class II restoration without pulpotomy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11528
    • Lygidakis Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Healthy children aged 3-9 years

  • At least one pulpotomy in a carious primary molar requiring a Class II resin restoration
  • At least one Class II cavity in a carious primary molar in the same patient that requires a resin restoration
  • The teeth to be restored must not present clinical signs of pulp necrosis, such as pathological mobility or abscess/fistula
  • Parents have signed an informed consent form
  • The young patients return for evaluation at 12 and 24 months
  • There is no exfoliation or extraction of the evaluated teeth before the 24-month period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Class II composite restoration on primary teeth with pulpotomy	Procedure: Class II restoration after pulpotomy; The same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. After pulpotomy completion with a layer of MTA®, an intermediate layer of glass ionomer cement (Vitrebond Plus™) is placed before the final composite resin restoration. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™).
Active Comparator: Class II composite restoration on primary teeth without pulpotomy	Procedure: Class II restoration without pulpotomy; The same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified USPHS criteria	Modified USPHS criteria are variations of the original United States Public Health Service criteria used in dentistry to clinically evaluate restorations. They include the following criteria: marginal adaptation, retention, marginal discoloration, and secondary caries, with specific parameters and scoring scales adjusted for a particular study or material being evaluated. These modifications allow for a more precise assessment of dental restorations by tailoring the evaluation to specific clinical situations or restorative materials	Assessment is done at 12 and 24 months following placement of the composite restoration

Collaborators and Investigators

• Sponsor: Lygidakis Dental Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pulpotomy; primary tooth; class II cavity
• Additional Relevant MeSH Terms: Dentistry; Endodontics; Pulpotomy
• Other Study ID Numbers: 1495 (Recep Tayyip Erdogan University, Department of Scientific Research Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No