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

NCT07243496 | Active Not Recruiting

• 1 other identifier: 1495
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Composite Restoration; Primary Tooth Pulpotomy

Keywords

class II cavity; primary tooth; pulpotomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Class II composite restoration on primary teeth with pulpotomy

ACTIVE COMPARATOR

Procedure: Class II restoration after pulpotomy

Class II composite restoration on primary teeth without pulpotomy

ACTIVE COMPARATOR

Procedure: Class II restoration without pulpotomy

Interventions

Class II restoration after pulpotomy PROCEDURE

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™).

Class II composite restoration on primary teeth with pulpotomy

Class II restoration without pulpotomy PROCEDURE

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™).

Class II composite restoration on primary teeth without pulpotomy

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Lygidakis Dental Clinic: lead

Study Sites (1)

Lygidakis Dental Clinic

Athens, 11528, Greece

Location

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)