NCT06346756

Brief Summary

This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins. The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p\<0.05).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

March 29, 2024

Last Update Submit

June 3, 2024

Conditions

Dental CariesDental Caries Class II

Outcome Measures

Primary Outcomes (1)

  • Retention

    No loss of restorative material

    seventh day, sixth month, twelfth month

Secondary Outcomes (7)

  • color match

    seventh day, sixth month, twelfth month

  • marginal adaptation

    seventh day, sixth month, twelfth month

  • marginal discoloration

    seventh day, sixth month, twelfth month

  • surface texture

    seventh day, sixth month, twelfth month

  • anatomical form

    seventh day, sixth month, twelfth month

  • +2 more secondary outcomes

Study Arms (4)

G-aenial A'CHORD universal composite

EXPERIMENTAL
Other: Treatment of dental caries.

Tetric Prime universal composite

EXPERIMENTAL
Other: Treatment of dental caries.

Filtek Ultimate universal composite

EXPERIMENTAL
Other: Treatment of dental caries.

G-aenial Universal Injectable composite

EXPERIMENTAL
Other: Treatment of dental caries.

Interventions

Treatment of dental caries.OTHER

The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.

Filtek Ultimate universal compositeG-aenial A'CHORD universal compositeG-aenial Universal Injectable compositeTetric Prime universal composite

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A patient presenting with;
  • over 18 years of age
  • a normal periodontal status and good general health
  • proximal caries that are similar in size to premolar and molar teeth
  • vital teeth
  • teeth in contact with the opposing tooth and subjected to normal occlusal forces
  • attend follow-up appointments

You may not qualify if:

  • poor oral hygiene status
  • those with severe or chronic periodontitis
  • absence of adjacent and antagonist teeth
  • potential behavioral problems (e.g. bruxism)
  • allergy to any product used in the study
  • exposure of the pulp during cavity preparation
  • systemically unhealthy
  • pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, Faculty of Dentistry

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Merve Gürses

    Selcuk University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

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
Assistant Professor

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 4, 2024

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 15, 2023

Last Updated

June 5, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)