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

NCT02891967 | Recruiting

• 1 other identifier: CEBD-CU-08-184
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Post Dental Restoration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bulk full composite (3M)

OTHER

bulk fill composite in posterior class one cavities

Other: bulk fill composite; Other: Nano resin composite (K Z350 xt)

Incremental packing composite resin

OTHER

Nano resin composite (K Z350 xt) restoration in class one cavities

Other: bulk fill composite; Other: Nano resin composite (K Z350 xt)

Interventions

bulk fill composite OTHER

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)

Bulk full composite (3M); Incremental packing composite resin

Nano resin composite (K Z350 xt) OTHER

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.

Bulk full composite (3M); Incremental packing composite resin

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mary

Cairo, Cairo Governorate, Egypt

RECRUITING

Study Officials

• Mary ST Tadros, Phd

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mary ST Tadros, Phd

CONTACT

01223729423; mora.dentist@hotmail.com

Mina GA Awad, Phd

CONTACT

01211958836; mora.doc04@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 8, 2016
• Study Start: January 1, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 30, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)