Status:
NOT_YET_RECRUITING
Pain and Anxiety in Pediatric Dentistry: Computer-Controlled vs. Traditional Anesthesia
Lead Sponsor:
Dicle University
Conditions:
Traditional Local Anesthesia
Computer-controlled Electronic Anesthesia
Eligibility:
All Genders
7-10 years
Phase:
NA
Brief 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 tra...
Detailed Description
This randomized controlled clinical trial will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University. The study will include 84 voluntary pediatric patients age...
Eligibility Criteria
Inclusion
- 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
- 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 evaluation or lacking intact dentin at the pulp border
- Teeth that do not respond positively to pulp vitality tests, or that show periradicular lesions or marked widening of the lamina dura on periapical radiographs
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT07156487
Start Date
October 1 2025
End Date
March 1 2026
Last Update
September 5 2025
Active Locations (1)
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1
Dicle University Faculty of Dentistry, Department of Pediatric Dentistry
Diyarbakır, Turkey (Türkiye), 21300