NCT05332041

Unknown

Assessment of Bioactive Bulk Fill Composite Versus High Visc...

Cairo University Source

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Other study identifiers

Sponsor study identifier

USPHS criteria

Study Type

interventional

Estimated enrollment

28

Locations

0 countries

Sites

N/A

Timeline

Study Start

July 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

July 1, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 1, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

This trial will be conducted to compare the clinical performance between a new bioactive resin composite material and high viscosity glass ionomer for restoring occlusal carious lesions of posterior teeth in patients scheduled for head and neck radiotherapy.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 28 participants
Study completion date: September 1, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 6, 2022
Actual (reported)
First Posted
April 18, 2022
Actual (reported)
Study Start
July 1, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: April 18, 2022
Status Verified: April 2022
Last Update Submitted: April 14, 2022

Conditions

Secondary Dental Caries

Outcome Measures

Primary Outcomes (1)

Secondary caries
biological outcome
one year follow up

Study Arms (2)

Predicta Bioactive bulk fil composite restoration

EXPERIMENTAL

Bioactive bulk fil resin composite dental restoration material

Other: Predicta Bioactive bulk fil composite restoration

High viscosity glass ionomer (Equia Fil)

ACTIVE COMPARATOR

High viscosity dental restoration material

Other: Predicta Bioactive bulk fil composite restoration

Interventions

Predicta Bioactive bulk fil composite restorationOther

Predicta Bioactive bulk fil resin composite restoration material

High viscosity glass ionomer (Equia Fil)Predicta Bioactive bulk fil composite restoration

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients Scheduled for head and neck radiotherapy.
age: ≥18 years.

Sponsors & Collaborators

Cairo University
Otherlead

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Neven Ahmed Ebrahim

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 18, 2022

Study Start

July 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

Patients with good likelihood of recall availability.

Permanent premolars or molars.

Primary occlusal carious lesions.

Vital with positive reaction to cold thermal stimulus.

Well-formed and fully-erupted.

You may not qualify if:

Participants with late stage head and neck cancer
Concomitant participation in another research study.
Inability to comply with study procedures
past experience with allergic reactions against any components of the used materials Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
N 2-Non-vital teeth. 3-Secondary carious lesions

Contact the study team to confirm eligibility.

July 1, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 1, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

April 18, 2022

Record last verified: 2022-04

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT05332041
Data provider: ClinicalTrials.gov
Source updated: 2022-04-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:53 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Predicta Bioactive bulk fil composite restoration

High viscosity glass ionomer (Equia Fil)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Design

Study Record Dates

You may not qualify if:

Source record