Clinical Evaluation of Different Resin Composite Restorations

Comparative Study of Clinical Criteria of Different Resin Composite Restorations Among Lower Molars

Posterior resin composite is challenging esthetic restoration. Patients seek for durable, esthetic and functional restorations in molars. one of the major problems is polymerization shrinkage. Some materials were developed to overcome the polymerization shrinkage, among them bulk fill resin composite which have been developed to reduce the shrinkage stress during polymerization and offer much greater depth of cure. This is achieved by the addition of fillers such as barium aluminum silicate filler, ytterbium trifluoride and mixed oxides. Furthermore, a prepolymerized fillers have been added with silanes to reduce shrinkage stress. so, the objective of this trial is to clinical Evaluate and compare clinical performance of bulk fill VS incremental filling technique.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of dental medicine Al Azhar university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

inclusion criteria of participants:

• Male gender
• Good oral hygiene
• Only Cooperative patient
• Medically free patient
• Age range 18-24

inclusion criteria of the teeth:

• Vital teeth with no periapical lesion or radiolucency.
• Prepared cavity with no undermined enamel walls.
• Functioning tooth with presence of an opposing.
• Healthy periodontium.

Exclusion Criteria:

• exclusion criteria of participants:

  • Old age patients
  • Patients have systemic disease or sever medically compromised
  • Patients with bruxism, clenching or temporomandibular joint disorder.
  • Por oral hygiene

exclusion criteria of teeth:

• Teeth with periapical lesions.
• Teeth with visible cracks.
• Teeth with mobility.
• Non-functioning tooth with no opposing tooth.
• Heavy occlusion or signs of sever attrition.
• Tooth with Periodontal affection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bulkfill composites; sonic fill 3 & PALFIQUE bulk flow bulk fill composite	Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X; dental filling materials
Active Comparator: incremental composites; Neo spectra & Clear fill AP-X incremental composites	Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X; dental filling materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative sensitivity	restorations will be evaluated the according to the modified United States Public Health Service (USPHS)	along one year
marginal discoloration	restorations will be evaluated the according to the modified United States Public Health Service (USPHS)	along one year
marginal adaptation	restorations will be evaluated the according to the modified United States Public Health Service (USPHS)	along one year
recurrent caries	restorations will be evaluated the according to the modified United States Public Health Service (USPHS)	along one year

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Nady Ebrahem Hasanin, professor, Faculty of dental medicine Al Azhar university

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Anticipated): October 2, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: composite resin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 732/385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No