Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT06272903
Eligibility Criteria:
Inclusion Criteria:
* Children with asymptomatic non pulpally involved carious primary molars who meet the indications of the HT in Dubai Dental Hospital.
* Children who require same tooth bilateral HT Crowns in either bilateral or diagonal pattern.
* Healthy male and female children, aged 4-10 years (ASA 1) with no conditions that affect sensory input/reaction.
* Children who are verbal and able to communicate.
* Not taking any painkillers, or other drugs that would influence with their pain perception.
* Cooperative children.
* Parents or guardians who consent for their children to be enrolled in the trial.
Exclusion Criteria:
* Children who are indicated for bilateral HT but do not require EOS, due to pre-existing interdental spaces.
* Children who are indicated for bilateral HT but parents prefer or indicate preference for the Modified HT.
* Children with allergies to nickel or other metal components that constitute a PMC.
* Those with reported allergies to topical or local anesthetic.
* Children with special health care needs or those who are non-verbal and are unable to communicate their pain levels.
* Children/parents/guardians not willing to participate in the study.
* Patients that require treatment under conscious sedation or general anesthesia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
10 Years
Study:
NCT06272903
Study Brief:
Protocol Section:
NCT06272903