Clinical trial NCT06354634: Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth
Official title: Clinical and Radiographic Success of Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel (3M ESPE) Crowns for Restoration of Primary Molar Teeth: a Split Mouth Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Tooth Decay
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 28
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will receive both interventions.
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection.

Detailed description: There is a lack of literary evidence for assessment of the properties of Bioflx crowns and their effect on clinical outcomes and parental satisfaction compared to traditionally available options including stainless steel crowns and zirconia crowns. Hence, this study plans to assess the clinical performance and child and parental satisfaction of Bioflx compared to the "gold standard" stainless steel crowns in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* Age: Children age group 3-7 yrs old
* Primary molars affected with caries or hypoplastic defect.
* Occlusion: Primary molar must have antagonist tooth.
* Consent of parent (legal guardians) and child assent for 7 years.
* Multi-surface dental caries observed in more than one tooth, in either side of the same arch (maxilla or mandible) or opposite arch (maxilla or mandible)
* Status: Asymptomatic or symptomatic teeth with signs of reversible pulpitis

Exclusion Criteria:

* Teeth with advanced stages of resorption (more than 2/3rd)
* Teeth exhibiting irreversible pulpitis.
* Teeth for which pulpotomy is done.
* Molar in infraocclusion
* Medically compromised children (ASA 3 or 4)
* History of grinding or pathological attrition
* Adverse gingival or periodontal conditions

Primary outcomes:
measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments
timeFrame: 3, 6, 12, 18, 24 and 36 months
measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments
timeFrame: 3, 6, 12, 18, 24 and 36 months
Secondary outcomes:
measure: Parental satisfaction
timeFrame: 3, 12, 24 and 36 months
measure: Child satisfaction
timeFrame: 3, 12, 24 and 36 months
measure: ECOHIS (Early Childhood Oral Health Impact Scale) survey
timeFrame: Pre-operative, 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: