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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.
Design: a randomized split-mouth study with two-way repeated measures design.
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 analgesia is a non-invasive, non-thermogenic bio-modulation of the dental pulp reactivity aiming for reduction of impulse formation of the pulpal nociceptors. It is based on the idea that parallel with the ablative high-energy level laser action, simultaneous low level laser therapy (LLLT) may occur. We hypothesize that when operating at pulse energies below the Er:YAG laser ablation threshold of tooth structure, the laser energy leads to loss of impulse conduction of type A-delta nerve fibers in the dental pulp, leading to an analgesic effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser analgesia | Experimental | Procedure: Laser analgesic procedure Performing protocol for pre-emptive laser analgesia with Er:YAG laser (Litetouch, Syneron) switched on. |
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| Placebo analgesia | Placebo Comparator | Procedure: Placebo analgesic procedure Performing imitation of laser analgesic protocol with Er:YAG laser (Litetouch, Syneron) switched off - no pulse energy applied. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser analgesic procedure | Procedure | Water mist spray set to "maximum", non-contact handpiece with sapphire tip. Tip-to-tissue distance 10 mm from the tooth neck, achieved by using a spacer. Energy is delivered to the enamel above the gingival margin adjacent to the cemento-enamel junction (perpendicularly towards the dental pulp) on each of the four line angles of the tooth for 30s, moving the laser handpiece in a sweeping action. Pulse energy - 0.2 W/ 10 Hz/ 20 mJ. Follows increase of energy and repetition of protocol - 0.6 W/ 15 Hz/ 40 mJ. Total duration of LA-induction - 240s. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain felt during treatment according to a visual analogue scale | Reported by the patient at the end of the dental treatment session on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pulpal sensibility to electrical stimuli by electrical pulp tester | Evaluated via electrical pulp tester (EPT) 5 minutes before and on the 5th and 20th minute after laser/placebo analgesic procedure. EPT result is a number. | 25 minutes |
| Changes in pulpal sensibility to cold-stimuli by a visual analogue scale |
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Exclusion criteria:
Inclusion criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Elitsa Veneva, DMD | Medical University - Plovdiv, Bulgaria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric Dentistry, Faculty of Dental Medicine | Plovdiv | 4000 | Bulgaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30572467 | Derived | Veneva E, Raycheva R, Belcheva A. Efficacy of erbium-doped yttrium aluminium garnet for achieving pre-emptive dental laser analgesia in children: A study protocol for a randomized clinical trial. Medicine (Baltimore). 2018 Dec;97(51):e13601. doi: 10.1097/MD.0000000000013601. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Allocation: Randomized Intervention Model: Split-mouth assignment with two-way repeated measures design Masking: Double (Participant, Outcomes Assessor)
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| Placebo analgesic procedure | Procedure | Performing imitation of laser analgesic procedure. No pulse energy applied, non-contact handpiece with sapphire tip. Moving the laser handpiece in a sweeping action towards the cemento-enamel junction (pointing perpendicularly towards the dental pulp) on each of the four line angles of the tooth. Total duration of placebo analgesia induction - 240s. |
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Cold-test is applied 4 minutes before and on the 6th and 21st minute after laser/placebo analgesia. Pain is reported by the patient on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). |
| 25 minutes |
| Patient experience during analgesic or placebo procedure | evaluated by a patient questionnaire | 5 minutes |
| Pain related behavior evaluated by the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale | Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain. | 1 hour |
| Dynamics of the heart rate of the patient | registered throughout the experiment via pulse oximeter | 1 hour |
| Need for local anesthesia infiltration during the treatment | Registered with 1=no; 2=yes. Patients who request that the procedure is terminated to administer an anesthetic injection, are asked to rate their level of pain, according to aforementioned visual analogue scale, immediately following termination. The visual analogue scale contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). | 1 hour |