NCT04274920

Brief Summary

The aim of this study is to evaluate the effect of application of bioactive glass in different protocols on the formation of dentin bridge after indirect pulp capping using resin composite with its adhesive both are containing bioactive glass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

February 10, 2020

Last Update Submit

February 17, 2020

Conditions

Pulp Disease, DentalDental Caries

Outcome Measures

Primary Outcomes (1)

  • Change of dentine thickness

    Thickness in millimeters using CBCT

    baseline, one month, 3 months and 6 months

Study Arms (2)

Bioactive Glass

EXPERIMENTAL

18 teeth were capped indirectly with dental adhesive containing bioactive glass applied according to the manufacturer's instructions and cured for 20 seconds and then resin composite restoration containing bioactive glass applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.

Other: Bioactive Glass

Light cured calcium hydroxide

ACTIVE COMPARATOR

18 teeth were capped indirectly with light cured calcium hydroxide (control group) applied according to the manufacturer's instructions by calcium hydroxide applicator and light cured for 20 seconds then resin composite restoration was applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.

Other: Light cured calcium hydroxide

Interventions

Bioactive GlassOTHER

Bioactive glass was incorporated in resin composite and its adhesive

Bioactive Glass
Light cured calcium hydroxideOTHER

Light cured calcium hydroxide

Light cured calcium hydroxide

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Active carious lesion in deep dentin of molars.
  • Absence of cavitated lesions at the buccal or lingual surfaces as determined by clinical and radiographic examination.
  • Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and abnormal tooth mobility;
  • Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure;
  • The extension of the carious lesion should be such that complete caries removal would risk pulp exposure, as determined by clinical and radiographic assessment;
  • Absence of radiolucencies at the interradicular or periapical regions, or thickening of the periodontal spaces, that would indicate the presence of irreversible pulp pathologies or necrosis;
  • Absence of internal or external root resorption.
  • Co-operative patients approving the trial.

You may not qualify if:

  • Patients with systemic medical conditions
  • pregnant females
  • Teeth with spontaneous pain or sensitivity to percussion.
  • Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
  • Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlAzhar University, Faculty of Dentistry for Girls

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp DiseasesDental Caries

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesTooth Demineralization

Study Design

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

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 18, 2020

Study Start

March 1, 2017

Primary Completion

May 1, 2018

Study Completion

July 1, 2018

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

EG(1)