Composite Restoration of Class II Cavities in Primary Molars With or Without Pulpotomy. Prospective 24 Month Clinical Trial.
NCT ID: NCT07243496
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-05-01
2026-05-01
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Class II composite restoration on primary teeth with pulpotomy
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™).
Class II composite restoration on primary teeth without pulpotomy
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™).
Interventions
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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™).
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™).
Eligibility Criteria
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Inclusion Criteria
* 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
3 Years
9 Years
ALL
No
Sponsors
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Lygidakis Dental Clinic
OTHER
Responsible Party
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Nikos Lygidakis
Dr
Locations
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Lygidakis Dental Clinic
Athens, , Greece
Countries
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Other Identifiers
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1495
Identifier Type: -
Identifier Source: org_study_id
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