UnknownNot Applicable

Clinical Performance of Two Different Restorative Materials in Restoring Class II Cavities of Primary Molars

Egypt124 participantsStarted 2022-12-30

Plain-language summary

The aim of the present study is to assess Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in class II cavities of primary molars regarding the following objectives: The primary objective To evaluate and compare the clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars after 3,6, and 12 months. The secondary objective To assess the effect of different independent variables on the treatment outcome of the experimental restorative materials. Research question: Is there a difference in the clinical performance between flowable giomers and highly viscous glass ionomer in restoring class II cavities of primary molars? Null Hypothesis There is no difference in the clinical performance between Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) after one year of follow up.

Who can participate

Age range

4 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 4 to 8 years old medically free children.
. Cooperative children classified as class 3 or 4 based on Frankel et al. classification
. Children who had at least one active dentinal carious lesion on proximal surface of primary molars
. Primary molars with active dentinal carious lesion on their proximal surface score 4, 5 using ICDAS.
. Primary molars with proximal carious lesion extended to outer and middle third of dentin scored D1and D2 that will be detected by bitewing radiograph.
. Simple or compound class II cavities be present
. The antagonist and the adjacent tooth should be present

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars

Timeframe: 12 months

Trial details

NCT IDNCT06000085

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06

Contact for this trial

Sarah Emad

01005699595 dent.sarah.emad@gmail.com

View on ClinicalTrials.gov More Dental Caries Class II trials

Plain-language summary

Who can participate

Age range

4 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 4 to 8 years old medically free children.
. Cooperative children classified as class 3 or 4 based on Frankel et al. classification
. Children who had at least one active dentinal carious lesion on proximal surface of primary molars
. Primary molars with active dentinal carious lesion on their proximal surface score 4, 5 using ICDAS.
. Primary molars with proximal carious lesion extended to outer and middle third of dentin scored D1and D2 that will be detected by bitewing radiograph.
. Simple or compound class II cavities be present
. The antagonist and the adjacent tooth should be present

Clinical Performance of Two Different Restorative Materials in Restoring Class II Cavities of Primary Molars

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Clinical Performance of Two Different Restorative Materials in Restoring Class II Cavities of Primary Molars

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria