CompletedPhase 4

Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars

Egypt17 participantsStarted 2023-01-30

Plain-language summary

this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials used for the indirect pulp capping

Who can participate

Age range

4 Years – 7 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

. Each child has bilateral vital cavitated carious lesions in primary molars.
. Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed.
. Patient and parent cooperation.
. Accessible isolation for the operated tooth with rubber dam.
. primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin .
. Availability of remaining dentin thickness over the pulp.
. Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption.

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

Thickness of dentin in mm

Timeframe: UP to 9 months postoperatively

Radiodenisty in Hounsfield units

Timeframe: UP to 9 months postoperatively

pulp vitality

Timeframe: UP to 9 months postoperatively

Trial details

NCT IDNCT06020911

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More Pulp Caping trials

Plain-language summary

Who can participate

Age range

4 Years – 7 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

. Each child has bilateral vital cavitated carious lesions in primary molars.
. Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed.
. Patient and parent cooperation.
. Accessible isolation for the operated tooth with rubber dam.
. primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin .
. Availability of remaining dentin thickness over the pulp.
. Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption.

Indirect Pulp Capping Using Biodentine and Theracal Light-cured in 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

Indirect Pulp Capping Using Biodentine and Theracal Light-cured in 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

Exclusion criteria