NCT04790383

Brief Summary

Clinical performance according to modified USPHS criteria of advanced self-Adhesive resin composite hybrid restorations is evaluated for 1 year versus conventional resin composite restorations in posterior teeth.

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
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 4, 2021

Last Update Submit

March 5, 2021

Conditions

Caries Class IICaries,Dental

Keywords

self-Adhesive resin composite hybrid restorationsPosterior resin compositeSurefil One

Outcome Measures

Primary Outcomes (1)

  • Clinical performance

    Post operative Hypersensitivity, Secondary caries, Gross fracture, Cavo-surface marginal discoloration, Proximal contact. All these outcomes are measured by a score Alpha is excellent, Bravo is acceptable, Charlie is not accepted

    Change from baseline at 6, 12 months

Study Arms (2)

Advanced Self-Adhesive resin composite hybrid restorations

EXPERIMENTAL

(Surefil one (Dentsply Sirona)).

Other: Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).

Conventional resin composite restoration.

ACTIVE COMPARATOR

Sphere Tec, (Dentsply Sirona)

Other: Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona

Interventions

Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).OTHER

Hybrid resin composite that doesn't need bonding system and releases calcium and flouride.

Advanced Self-Adhesive resin composite hybrid restorations
Conventional resin composite restoration. (Sphere Tec, (Dentsply SironaOTHER

Conventional Nanohybrid resin composite

Conventional resin composite restoration.

Eligibility Criteria

Age17 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with carious proximal cavities in molars
  • Good oral hygiene.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

You may not qualify if:

  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Severe periodontal problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Related Links

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Rawda Hesham Hesham A.ElAziz

CONTACT

+201001097200rawda.hesham@dentistry.cu.edu.eg

Dina Ezz Eldin Mohamed

CONTACT

+20 100 800 7157Dina.ezz@dentistry.cu.edu.eg

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
SPONSOR INVESTIGATOR
PI Title
lecturer at Conservative Dentistry department

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 10, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)