Status:
COMPLETED
Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children
Lead Sponsor:
Plovdiv Medical University
Conditions:
Caries, Dental
Eligibility:
All Genders
10-12 years
Phase:
NA
Brief Summary
The aim of this study is to determine the effectiveness of Er:YAG pulse therapy for achieving pulpal analgesia in pediatric patients and to quantify the duration and extent of any effects assessed. D...
Detailed Description
The intention of the technique of "pre-emptive laser analgesia" is to reduce sensation in that small percentage of patients who may experience unpleasant sensations during caries removal. Laser analge...
Eligibility Criteria
Inclusion
- Exclusion criteria:
- Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events, radiotherapy in the maxillofacial region due to malignant process.
- Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
- Children, who are first time ever dental patients.
- Inclusion criteria:
- Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- Patients who are not undergoing treatment or have been treated 6 months prior to inclusion with remineralizing agents.
- Patients, requiring conservative treatment of occlusal, caries on foramen caecum, and/or proximal caries on two first permanent upper jaw molars without prior restorations or dental sealants. Lesions are to be classified as moderate caries by the International caries detection and assessment system (ICDAS) with code 03 or code 04, which do not present spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating of pulpal pathology. Included are carious lesions only on vital teeth, involving up to half of the dentine thickness, with no periodontal pathology. Laser fluorescence diagnosis of adjacent lesions with DIAGNODENT is limited to 20 - 35 scores included.
- Included are first molars which are not affected by hypoplasia or hypomineralization.
- Obtained informed consent from parents or gave-givers to participate in the study, in which laser treatment and study procedures are explained in appropriate manner.
Exclusion
Key Trial Info
Start Date :
October 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03412721
Start Date
October 6 2018
End Date
September 8 2019
Last Update
June 4 2021
Active Locations (1)
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1
Department of Pediatric Dentistry, Faculty of Dental Medicine
Plovdiv, Bulgaria, 4000