Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth

Dental Caries Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354634
• Other study ID #: HM20028439
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2027

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD
• Phone: 804-828-2362
• Email: jayaramanj[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Parental satisfaction	The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.	3, 12, 24 and 36 months
Secondary	Child satisfaction	The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.	3, 12, 24 and 36 months