Active — Not RecruitingNot Applicable

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

Greece40 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range3 Years – 9 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Modified USPHS criteria

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

Trial details

NCT IDNCT07243496

SponsorLygidakis Dental Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-01

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