Clinical Evaluation of Different Resin Composite Restorations

NCT05418400 | Unknown

• 1 other identifier: 732/385
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

composite resin

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

bulkfill composites

ACTIVE COMPARATOR

sonic fill 3 \& PALFIQUE bulk flow bulk fill composite

Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X

incremental composites

ACTIVE COMPARATOR

Neo spectra \& Clear fill AP-X incremental composites

Other: sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X

Interventions

sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X OTHER

dental filling materials

bulkfill composites; incremental composites

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male gender
• Good oral hygiene
• Only Cooperative patient
• Medically free patient
• Age range 18-24
• Vital teeth with no periapical lesion or radiolucency.
• Prepared cavity with no undermined enamel walls.
• Functioning tooth with presence of an opposing.
• Healthy periodontium.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of dental medicine Al Azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nady Ebrahem Hasanin, professor

  Faculty of dental medicine Al Azhar university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 14, 2022
• Study Start: August 15, 2022
• Primary Completion: October 2, 2023
• Study Completion: November 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)