One-year Clinical Evaluation of Bulk-fill Versus Conventional Incremental Posterior Restoration by FDI Criteria

Post Dental Restoration Clinical Trial

Official title:

One-year Clinical Evaluation of Bulk-fill Resin Composite Using FDI Criteria in Comparison to Conventional Incremental Posterior Restoration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02891967
• Other study ID #: CEBD-CU-08-184
• Status: Not yet recruiting
• Phase: N/A
• First received: August 30, 2016
• Last updated: September 7, 2016
• Start date: January 2018
• Est. completion date: April 2019

Study information

• Verified date: September 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

restoring posterior teeth by bulk fll and nanofill composite and clinical evaluation of performance and durability of both restorations during one year follow up

Description:

The treated cavities will be divided into 2 groups, cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²) and other group of cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.

Articulation will be checked carefully with an articulating paper and occlusal adjustments will be performed using flame shaped carbide and diamond finishing burs (DENTSPLY) using water spray, restorations will be finished occlusally with finishing burs and finally polished with aluminium oxide polishing paste and a rubber cup (DENTSPLY).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 69
• Est. completion date: April 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• Good oral hygiene.Patients must show no signs of orofacial pain. The presence of molar teeth requiring composite restorations for the treatment of primary carious lesions

Exclusion Criteria:

• Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations. Teeth with old restorations or severely destructed dental crowns.Tempro-mandibular joint problems involving symptomatic pain.Pregnancy or breast feeding, acute and chronic systemic diseases, immune-compromised patients

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Post Dental Restoration

Intervention

Other:
• bulk fill composite
cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²)
• Nano resin composite (K Z350 xt)
cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical performance and durability of restoration	Outcome measure is Clinical performance and durability of composite resin restoration, Device for measurement is FDI criteria , Unit of measurement is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor.	one year	Yes