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

Lygidakis Dental Clinic

Status: Active, not recruiting

Conditions: Composite Restoration; Primary Tooth Pulpotomy

Treatments: Procedure: Class II restoration without pulpotomy; Procedure: Class II restoration after pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07243496

1495 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

Class II composite restoration on primary teeth with pulpotomy

Active Comparator group

Treatment:

Procedure: Class II restoration after pulpotomy

Class II composite restoration on primary teeth without pulpotomy

Active Comparator group

Treatment:

Procedure: Class II restoration without pulpotomy