NCT05949502

Brief Summary

A clinical trial, comparing the clinical performance and occlusal wear resistance of two different restorative materials in restoring proximal caries in permanent posterior teeth. One is based on giomer technology and the other is nano-hybrid resin composite.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

June 24, 2023

Last Update Submit

July 14, 2023

Conditions

Caries Class II

Keywords

Low-shrinkage GiomerNano-hybrid compositeRevised FDI criteria

Outcome Measures

Primary Outcomes (1)

  • Functional properties (F1) Fracture of material and retention according to revised FDI (World Dental Federation) criteria. Measured by visual examination and short air drying.

    Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).

    24 months

Secondary Outcomes (4)

  • Quantitative occlusal restoration wear by Digital Intra-oral scanner and Geometrical subtraction software.

    24 months.

  • Functional properties according to revised FDI (World Dental Federation) criteria.

    24 months.

  • Biological properties according to revised FDI criteria.

    24 months.

  • Aesthetic properties according to revised FDI criteria.

    24 months.

Study Arms (2)

Low shrinkage giomer.

EXPERIMENTAL

Low-shrinkage bioactive material (giomer) will be applied according to the manufacturer's instructions. Centripetal technique will be performed to restore the proximal wall followed by oblique incrementation of approximately 2 mm thick composite resin. This will be followed by light curing of each increment for 40 seconds using light curing unit till the whole cavity is filled.

Drug: Beautifil II LS (Low-Shrinkage)

Nano-hybrid resin composite

ACTIVE COMPARATOR

Nano-hybrid resin composite will be applied according to the manufacturer's instructions. Centripetal technique will be performed to restore the proximal wall followed by oblique incrementation of approximately 2 mm thick composite resin. Composite increments will be adapted obliquely on each cusp. This will be followed by light curing for 40 seconds using light curing unit of each increment till the whole cavity is filled.

Drug: 3M Filtek Z250 XT Universal

Interventions

Beautifil II LS (Low-Shrinkage)DRUG

low shrinkage bioactive material Giomer

Also known as: low shrinkage Giomer
Low shrinkage giomer.
3M Filtek Z250 XT UniversalDRUG

Universal Nano-hybrid composite

Also known as: Nano-hybrid composite
Nano-hybrid resin composite

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient's age ranging from 19-30
  • Good oral hygiene.
  • Patients who have stable occlusion.
  • Patients who could be present for further periodic follow-ups.
  • Possibility for application of rubber dam during restoration.
  • Patient compliance.
  • Vital first and second molars, with compound Class II lesions.
  • The selected teeth should be in occlusion with natural dentition and having proximal contact with adjacent teeth.
  • Healthy periodontium.

You may not qualify if:

  • Poor oral hygiene.
  • Patients with high caries index or high plaque index.
  • Patients with periodontal problems.
  • Heavy bruxism habit or presence of any parafunctional habits.
  • Any allergic reactions against any components of the materials to be used in the study.
  • History of severe medical complications such as xerostomia.
  • Pregnant or lactating women.
  • Participating in another clinical trial.
  • Fractured or evidently cracked teeth.
  • Defective restorations adjacent or opposite the selected tooth for research.
  • Atypical extrinsic staining of teeth.
  • Teeth with defects or lesions requiring other operative interventions.
  • Teeth with pulpal pain.
  • Teeth with periapical lesions.
  • Root Canal treated teeth.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

ENA-HRi nano-hybrid composite

Central Study Contacts

Marwa AbdelHafez, MS.C

CONTACT

00201002894668Marwa.abdelHafez@dentistry.cu.edu.eg

Study Design

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

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 18, 2023

Study Start

August 1, 2023

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share