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.

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Key information

Conditions

Composite Restoration Primary Tooth Pulpotomy

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lygidakis Dental Clinic

Athens, 11528, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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™).

Primary outcomes

Modified USPHS criteria

Time frame: Assessment is done at 12 and 24 months following placement of the composite restoration

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

Sponsors and collaborators

Lead sponsor

Lygidakis Dental Clinic

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Nov 24, 2025
Registry last updated: Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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