NCT05332041

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

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

First Submitted

Initial submission to the registry

April 6, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

April 6, 2022

Last Update Submit

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

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.
  • 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.

Sponsors & Collaborators

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

Primary Completion

July 1, 2023

Study Completion

September 1, 2023

Last Updated

April 18, 2022

Record last verified: 2022-04