CompletedPhase 2

Root Canal Treatment in Primary Molars With Necrotic Pulp Using Two Different Pulp Therapies

Brazil86 participantsStarted 2018-06-04

Plain-language summary

This is a controlled, randomized, double-blind clinical study (researcher and research participant does not know which group they belong to), with the objective of evaluating clinical and radiographic performances of primary molar canal treatments with necrotic pulps using two obturator pulps. The CTZ paste (composed of chloramphenicol, tetracycline, zinc oxide and eugenol) and the ZOE paste (composed of zinc oxide and eugenol). The CTZ paste represents an alternative treatment that makes possible to treat canals of primary molars in a simplified way, without instrumentation of root canals. Studies with the CTZ pulp have demonstrated satisfactory clinical and radiographic results in addition to biocompatibility and good antimicrobial action. The zinc oxide and eugenol paste has been studied, presents good clinical and radiographic results, it is indicated by the American Academy of Paediatric Dentistry and requires mechanical chemical preparation of the root canals. Children of both sexes, frequenters of the paediatric dentistry clinic of the Federal University of Piaui who present lower deciduous molars with clinical history and / or radiographic evidences of pulp necrosis will participate in the study. The hypothesis of the study is that both pastes present similar clinical and radiographic results.

Who can participate

Age range

3 Years – 9 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: * Lower primary molars with clinical and / or radiographic history of pulp necrosis. * Crown with sufficient dental structure to be restored with stainless steel crown. * Rhizolysis equal to or less than 1/3. Exclusion Criteria: * Teeth that present calcium metamorphosis. * Pathological root resorption. * Coronary destruction that makes it impossible for the tooth to be restored. * You have been using antibiotics for the last three months.

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

Infection control of deciduous molars with necrotic pulp by clinical examination

Timeframe: up to 36 months

Infection control of deciduous molars with necrotic pulp by Radiographic examination

Timeframe: up to 36 months

Trial details

NCT IDNCT03650036

SponsorFederal University of Piaui

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-21

View on ClinicalTrials.gov More Dental Pulp Necrosis trials