Pain and Anxiety in Pediatric Dentistry: Computer-Controlled vs. Traditional Anesthesia (NCT07156487) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pain and Anxiety in Pediatric Dentistry: Computer-Controlled vs. Traditional Anesthesia
Turkey (Türkiye)84 participantsStarted 2025-10
Plain-language summary
The purpose of this clinical study is to evaluate how different local anesthesia techniques affect pain and anxiety levels in children undergoing dental treatment. Specifically, the study compares traditional syringe-based anesthesia with a computer-controlled local anesthesia system.
The study seeks to answer the following question: Which combination of anesthesia technique is most effective in reducing pain and anxiety in pediatric dental patients?
By understanding the impact of these variables, the study aims to help dental professionals choose the most appropriate anesthesia approach to improve the comfort and emotional well-being of children during dental procedures.
Who can participate
Age range
7 Years – 10 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:
* Patients classified as ASA I in general systemic health
* Children between 7 and 10 years of age
* Absence of any syndromic condition
* No physical or mental disability
* No prior dental treatment experience
* Frankl Behavior Rating Scale Class III or IV
* Presence of carious lesions limited to less than one-third of the buccolingual distance between cusp tips on the occlusal surfaces of primary or permanent molars on both sides
* Radiographic evidence of caries involving up to half of the dentin thickness with intact dentin at the pulp-dentin border in primary or permanent molars on both sides
* Teeth on both sides responding positively to pulp vitality tests, with no periradicular pathology or significant widening of the lamina dura on periapical radiographs
Exclusion Criteria:
* Patients with mild or severe systemic diseases or those undergoing medical treatment
* Patients younger than 7 or older than 10 years of age
* Uncooperative or noncompliant patients classified as Class I or Class II according to the Frankl Behavior Rating Scale
* Patients requiring urgent dental treatment
* Patients with wide carious lesions extending beyond one-third of the buccolingual distance between cusp tips on the occlusal surfaces
* Patients with carious lesions limited to less than one-third of the buccolingual width only on one side of the jaw
* Teeth with carious lesions not reaching half of the dentin thickness on radiographic evalu…
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
1
To assess the patient's pain level (Before and after anesthesia)
Timeframe: through study completion, an average of 6 month.
2
To assess the patient's pain level (During anesthesia)
Timeframe: through study completion, an average of 6 month.
3
To assess the patient's pain level (During anesthesia)
Timeframe: through study completion, an average of 6 month.
4
To assess the patient's anxiety level (Before anesthesia )
Timeframe: through study completion, an average of 6 month.
5
To assess the patient's anxiety level (Before and after anesthesia)
Timeframe: through study completion, an average of 6 month.
6
Pulse rate measurement to assess patient's dental anxiety (Before,after and during anesthesia)
Timeframe: through study completion, an average of 6 month.
7
Blood oxygen saturation measurement to assess patient's dental anxiety (Before,after and during anesthesia)