NCT04557657

Brief Summary

The aim of this study is to evaluate of marginal integrity of indirect composite restoration after cementation by a bioactive cement in comparison to dual cure resin cement using Modified USPHS criteria

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
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2019

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

September 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

September 11, 2020

Last Update Submit

January 26, 2021

Conditions

Resin Cement

Keywords

Composite blocksCad/CamCerec

Outcome Measures

Primary Outcomes (1)

  • Marginal Discoloration

    Check Marginal Discoloration Using Modified USPH criteria

    12 Months

Study Arms (2)

Control Group Resin cement

EXPERIMENTAL

Control group Using resin cement

Drug: Resin Cement

Intervention Group Active Cement

ACTIVE COMPARATOR

Intervention Group Using active cement bio activa

Drug: Active bio Activa

Interventions

Active bio ActivaDRUG

Cement that release fluoride

Also known as: Active Cement Pulpodent
Intervention Group Active Cement
Resin CementDRUG

Resin Cement Convinonal

Control Group Resin cement

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with badly broken vital teeth with minimum of two remaining walls
  • Adult Males or female 16- 65 years old
  • Good oral hygiene measures with a good gingival condition
  • Cooperative patients approving to participate in the study
  • Free of any medical condition that interfere with procedures

You may not qualify if:

  • Patients with a compromised medical history.
  • Severe or active periodontal disease
  • Endodontically treated teeth
  • Severe medical complications Lack of compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, EL Manial, 12566, Egypt

Location

MeSH Terms

Interventions

Resin Cements

Intervention Hierarchy (Ancestors)

Resins, SyntheticPlasticsPolymersMacromolecular SubstancesDental CementsDental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 36 volunteer assigned randomly into 2 equal groups of 18
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 21, 2020

Study Start

September 1, 2019

Primary Completion

October 30, 2019

Study Completion

March 1, 2021

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Individual patient Data can be shared Upon request

Shared Documents
STUDY PROTOCOL
Time Frame
1 Year
Access Criteria
Mail

Locations

EG(1)