Dental Caries Clinical Trial
Official title:
Efficiency of Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Dental Patients
The aim of the study is to assess the efficacy of a modified version of the behaviour management technique Latent inhibition in combination with Er:YAG laser for achieving reduction of dental anxiety in paediatric dental patients. The main objectives are to compare dental anxiety felt during the laser and conventional dental treatment. The outcomes will be dental anxiety assessment by a self-reported anxiety during treatment in both group as well as measurement of heart rate dynamics during the procedures.
Status | Not yet recruiting |
Enrollment | 82 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: 1. Participants in the study are children aged 6-12 years, compliant with the cognitive development of the child and the requirement for complete root development; 2. Children, requiring conservative treatment of occlusal carious lesions on a second primary molar, without spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating pulp involvement or periodontal pathology. Lesions are classified as distinct cavity with visible dentin without prior restoration or sealants by the International Caries Detection and Assessment System (ICDAS) with code 05. Included are caries lesions only on vital teeth. 3. Children with one or more permanent molars giving indications for pit and fissure sealing; 4. Patients without previous experience with laser treatment of carious lesions; 5. Children who are not considered medically compromised or medically complex patients; 6. Verbal assent from the child willing to comply with all study procedures and protocol; 7. Obtained written informed consent by the patient's parent/guardian for participation in the study Exclusion Criteria: 1. Patients who were undergoing therapy with neurological, sedative, analgesic, and/or anti-inflammatory drugs 7 days prior to treatment that might affect heart rate; 2. Children, who were first-time dental patients; 3. Children with systemic diseases or physiological development delays; 4. Children with mental or cognitive problems; 5. Present infectious diseases such as influenza, scarlet fever, etc. 6. Excluded are molars which are affected by disturbances in the development of dental structures (hypoplasia, hypomineralization, fluorosis) |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria | Plovdiv |
Lead Sponsor | Collaborator |
---|---|
Plovdiv Medical University |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | self-report dental anxiety on a modified version of the self-report Faces Scale by LeBaron | The scale comprises a row of five faces ranging from 'relaxed' to 'very worried' in combination with a visual analog scale of 0 - 10. Each child was asked to point to the face or choose the number which most closely depicted its state of anxiety. | Immediately after the dental treatment | |
Secondary | Heart rate | Dynamics of heart rate, registered during the treatment session measured throughout the whole treatment session with a mobile pulse oximeter, placed on the index finger of the left hand | start: in the waiting room, at least 5 minutes before the dental treatment. End: at least 5 minutes after the dental treatment. |
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