NCT03859284

Brief Summary

With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 12, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

February 12, 2019

Last Update Submit

October 27, 2020

Conditions

Dental Restoration Failure

Outcome Measures

Primary Outcomes (1)

  • Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes

    Biological properties (Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral \& general health). Esthetic properties (Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form). Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour \&wear (quantitatively \& qualitatively), Proximal anatomical form(contact point \&contour), Radiographic examination(when applicable) \&Patient's view For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor). Subscales will not be combined

    Change from the baseline at 6 months and12 months]

Study Arms (3)

flowable resin-composite

ACTIVE COMPARATOR

3M flowable composite is a conventional restoration to treat anterior carious cervical lesions. considered to be the gold standard of the flowable composites. other names: ''flowable composite ''

Other: flowable resin composite

self-adhering flowable

EXPERIMENTAL

intervention one is moist bonding self adhering flowable composite that binds to tooth without an adhesive system

Other: self adhering flowable

self-adhering flowable with adhesive

EXPERIMENTAL

intervention two moist bonding self adhering flowable composite that binds to tooth with the aid of adhesive system to improve the clinical performance

Other: self adhering flowable with adhesive

Interventions

flowable resin compositeOTHER

gold standard

Also known as: conventional flowable composite
flowable resin-composite
self adhering flowableOTHER

moist bonding self adhering flowable composite

Also known as: embrace wet bond
self-adhering flowable
self adhering flowable with adhesiveOTHER

moist bonding self adhering flowable composite with the aid of an adhesive system.

Also known as: embrace wet bond with adhesive
self-adhering flowable with adhesive

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with anterior cervical carious lesions.
  • Pulp asymptomatic vital carious anterior teeth.
  • Co-operative patients approving to participate in the trial.

You may not qualify if:

  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection.
  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Heavy smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Adhesives

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

mona mounir, msc

CONTACT

01001171585monamounir1987@gmail.com

hussein gomaa, PhD

CONTACT

drgomaadent@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

February 12, 2019

First Posted

March 1, 2019

Study Start

June 20, 2020

Primary Completion

February 1, 2021

Study Completion

June 1, 2022

Last Updated

October 29, 2020

Record last verified: 2020-10

Locations

EG(1)