NCT06354634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 7, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

March 27, 2024

Last Update Submit

February 25, 2025

Conditions

Dental CariesTooth Decay

Outcome Measures

Primary Outcomes (2)

  • The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments

    The clinical outcomes will be measured and reported in the data table based on the number of participants scored on 3-point Likert scale (Ideal, Acceptable, or Not Acceptable) for the following parameters separately: Contour of crown, gingival health, staining of crown, surface roughness of crown, opposing tooth, color match of crown, marginal fit, marginal discoloration, recurrent caries.

    3, 6, 12, 18, 24 and 36 months

  • The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments

    The radiographic outcomes will be measured and reported in the data table based on the number of participants scored on either presence or absence (yes / no) of the findings for the following parameter separately: Widening of periodontal ligament space, furcation radiolucency, periapical pathology, alveolar crestal bone loss, internal root resorption and external root resorption.

    3, 6, 12, 18, 24 and 36 months

Secondary Outcomes (3)

  • Parental satisfaction

    3, 12, 24 and 36 months

  • Child satisfaction

    3, 12, 24 and 36 months

  • ECOHIS (Early Childhood Oral Health Impact Scale) survey

    Pre-operative, 6, 12, 24 and 36 months

Study Arms (1)

All participants

EXPERIMENTAL

Each participant will receive a BioFLX crown and a stainless steel crown.

Other: Resin polymer (NuSmile Bioflx) crownOther: Stainless steel crown

Interventions

Resin polymer (NuSmile Bioflx) crownOTHER

Resin polymer (NuSmile Bioflx)crown

All participants
Stainless steel crownOTHER

Stainless steel crown

All participants

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Crowns

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Each participant will receive both interventions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 9, 2024

Study Start

June 7, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)