NCT02888873

Brief Summary

The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
Last Updated

September 5, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

August 24, 2016

Last Update Submit

August 30, 2016

Conditions

Dental Caries

Keywords

composite resinClinical trialFDI (World Dental Federation) criteria

Outcome Measures

Primary Outcomes (1)

  • Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.

    "Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"

    The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

Secondary Outcomes (1)

  • Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.

    The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

Other Outcomes (1)

  • Observers evaluated the biological properties of the restorations using FDI (World Dental Federation) Criteria.

    The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

Study Arms (2)

Charisma

ACTIVE COMPARATOR

applied randomly

Other: Charisma

Charisma classic

ACTIVE COMPARATOR

applied randomly

Other: Charisma Classic

Interventions

CharismaOTHER

The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma was used in combination Gluma2 Bond etch\&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.

Also known as: universal composite
Charisma
Charisma ClassicOTHER

The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma classic was used in combination Gluma2 Bond etch\&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.

Also known as: universal composite
Charisma classic

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a need for at least two but not more than four posterior tooth-colored restorations
  • the presence of teeth to be restored in occlusion
  • teeth that were symptomless and vital
  • a normal periodontal status
  • a good likelihood of recall availability.

You may not qualify if:

  • partly erupted teeth
  • absence of adjacent and antagonist teeth
  • poor periodontal status
  • adverse medical history
  • potential behavioral problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University School of Dentistry

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

  • Gurgan S, Vural UK, Kutuk ZB, Cakir FY. Comparison of two universal composites in posterior teeth: preliminary report. J Dent Res (Spec Iss 94 B): 308, 2015

    RESULT

  • Gurgan S, Koc Vural U, Kutuk ZB, Cakir FY. Does a new formula have an input in the clinical success of posterior composite restorations? A chat study. Clin Oral Investig. 2021 Apr;25(4):1715-1727. doi: 10.1007/s00784-020-03472-5. Epub 2020 Aug 3.

    PMID: 32748072DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Charisma composite resin

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Sevil Gurgan, DDS, PhD

    Hacettepe University School of Dentistry

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 5, 2016

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

TU(1)