NCT02868918

Brief Summary

The aim of this study is to compare the effect of new bioactive dentine substitute (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and radiographically using digital radiography in the terms of postoperative pain and biocompatibility to the pulp.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

August 6, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

August 6, 2016

Last Update Submit

September 14, 2022

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (1)

  • postoperative hypersensitivity using yes or no questionnaire

    6 months

Secondary Outcomes (1)

  • Biocompatibility of biodentine using digital X-ray

    6 months

Study Arms (2)

biodentine

EXPERIMENTAL

bioactive dentin substitute used to act like natural dentin in insulating the pulp against external stimuli intervention

Drug: biodentineDevice: DigoraH optium

glass ionomer cement

ACTIVE COMPARATOR

high viscosity glass ionomer used as a base material comparator other name : - fuji ix

Drug: glass ionomer cementDevice: DigoraH optium

Interventions

biodentineDRUG

tricalcium silicate cement used to replace the carious dentin

Also known as: tricalcium silicate
biodentine
glass ionomer cementDRUG

high viscosity glass ionomer used as a base material

Also known as: Fuji ix
glass ionomer cement
DigoraH optiumDEVICE

digital Xray for follow up

Also known as: digital radiography
biodentineglass ionomer cement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients male or female older than 18 y in good general health
  • A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical (PA) radiograph; Clinically according to International Caries Detection and Assessment System (ICDAS II) score 4
  • Clinical symptoms of reversible pulpitis
  • Positive pulp response to electric pulp test or thermal stimulation
  • No PA changes viewed on PA radiograph

You may not qualify if:

  • Clinical symptoms of irreversible pulpitis requiring endodontic treatment
  • Presence of fistulas or swelling
  • Mobile teeth or tenderness to percussion
  • Anterior teeth with aesthetic concerns
  • Pregnant women, in view of requirements for radiographs
  • Patients younger than 18 y
  • Patients unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omnia Magdy

Cairo, 02, Egypt

Location

MeSH Terms

Interventions

tricalcium silicateGlass Ionomer Cementsfuji IXRadiographic Image Enhancement

Intervention Hierarchy (Ancestors)

Dental CementsDental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureImage EnhancementPhotographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiography

Study Officials

  • Ahmed Elkhadem, PhD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer , Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University

Study Record Dates

First Submitted

August 6, 2016

First Posted

August 16, 2016

Study Start

February 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

EG(1)