CompletedPhase 4

Indirect Pulp Treatment in Primary Molars

Egypt88 participantsStarted 2016-08

Plain-language summary

This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.

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

. Medically free children, their parent(s) accepts to sign the informed consent.
. Age range from 4-8 years.
. Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
. Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
. Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).

Exclusion criteria

. Uncooperative children.
. Parents unable to attend follow up visits (even after explaining the importance of recall visits).
. History of spontaneous pain (to exclude reversible pulpitis).
. Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
. Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).

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

Number of cases reporting postoperative pain

Timeframe: 12 months

Number of cases reporting swelling

Timeframe: 12 months

Number of cases reporting sinus

Timeframe: 12 months

Number of cases reporting fistula

Timeframe: 12 months

Number of cases reporting tooth mobility

Timeframe: 12 months

Trial details

NCT IDNCT03770871

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

View on ClinicalTrials.gov More Dental Caries trials

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

. Medically free children, their parent(s) accepts to sign the informed consent.
. Age range from 4-8 years.
. Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
. Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
. Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).

Exclusion criteria

. Uncooperative children.
. Parents unable to attend follow up visits (even after explaining the importance of recall visits).
. History of spontaneous pain (to exclude reversible pulpitis).
. Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
. Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).