RecruitingNot Applicable

Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study

Egypt45 participantsStarted 2023-05-20

Plain-language summary

The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts.

Who can participate

Age range

6 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: * 1- Apparently healthy and medically free children. 2- Their age ranges from 6-8 years. 3- Both boys and girls will be included. 4- Children should have mandibular permanent first molars with the following clinical and radiographic criteria. 4.1Restorable young permanent first molars. 4.2Absence of clinical evidence of pulp degeneration: * No history of spontaneous pain, history of night pain or pain that not relieved by analgesics. * No pain on percussion. * No mobility. * Absence of abscess, purulent sinus or soft tissue edema. * Bleeding should stop within 5 minutes after the amputated pulp stumps. Exclusion Criteria: * Internal root resorption. * External root resorption. * Inter radicular or periapical bone destruction (radiolucency) * A deep carious lesion radiologically that approaches the pulp

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

Clinically assessment (Modified visual analogue scale)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Clinically assessment (Millar's index)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Clinically assessment (presence or abscence)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Radiographic assessment (using Image J software program)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Radiographic assessment (using Image J software program)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Radiographic assessment (using Image J software program)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Trial details

NCT IDNCT06372561

SponsorSuez Canal University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-20

Contact for this trial

Mennatallah Hesham El shaabany, doctorate student

01012906460 menna.hesham@dent.suez.edu.eg

View on ClinicalTrials.gov More Dental Caries in Children trials

Plain-language summary

Who can participate

Age range

6 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.

What they're measuring

Clinically assessment (Modified visual analogue scale)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Clinically assessment (Millar's index)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Clinically assessment (presence or abscence)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Radiographic assessment (using Image J software program)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Radiographic assessment (using Image J software program)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Radiographic assessment (using Image J software program)

Timeframe: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months