Pain Clinical Trial
Official title:
The Use of DryShield and Rubber Dam Isolation Systems Among Pediatric Patients With Different Airway Patency: A Randomized Clinical Trial
This randomized clinical trial will aim to evaluate the effect of DryShield isolation (DSI) and Rubber Dam isolation (RDI) systems on arterial oxygen saturation (SpO2), heart rate (HR), blood pressure (BP), behavior, subjective pain and discomfort, and time required among children with different airway patency based on Modified Mallampati classification (MMC). Healthy, cooperative 6-12-year-old children who need fissure sealant in at least two contralateral fully erupted permanent first molars will be included. The airway patency will be determined using MMC by two trained and calibrated dentists. Participants will be categorized based on their MMC score into patent airway (MMC Class I and II) and non-patent airway (MMC Class III and IV). During the treatment, the dental procedure will be videotaped, and the vital signs, including SpO2, HR, and BP, will be recorded every three minutes. A Validated Arabic Version of the Wong-Baker Pain Rating and the Face, Legs, Activity, Cry, Consolability (FLACC) scales will be utilized to record the participants' pain levels. In contrast, Frankl's Behavior will record their behavior during the dental procedure. Following the dental treatment, the participants' subjective pain and discomfort will be evaluated using a previously validated Arabic interview questionnaire.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | January 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: 1. Healthy 2. Cooperative 3. 6-12-year-old children 4. Who need fissure sealants in at least two contralateral fully erupted permanent first molar Exclusion Criteria: 1. Children with partially erupted, previously restored, or carious first molars. 2. Children with uncooperative behavior during their previous dental treatment. 3. Children with fixed orthodontic appliances 4. Children with nasal obstruction |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King AbdulAziz University | Jeddah |
Lead Sponsor | Collaborator |
---|---|
King Abdulaziz University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arterial oxygen saturation | Five minutes after the participant is seated on the dental chair, a pulse oximeter (OxyWatch, ChoiceMMed, Hamburg, Germany) will be placed on the right forefinger to record the arterial oxygen saturation. | Baseline before starting the dental procedure and then during the procedure at three-minute intervals until the removal of the isolation system. | |
Primary | Behavior | The dental procedure will be videotaped using a high-resolution camera fixed in the clinic. The recorded videos will be used to assess the participants's behavior using Frankl behavior classification by two trained and calibrated evaluators independently. | During the dental procedure. | |
Primary | Subjective pain and discomfort | The participants' subjective pain and discomfort will be evaluated using a validated Arabic Version of the Wong-Baker Pain Rating Scale and a previously validated Arabic interview questionnaire. | immediately after the end of the dental procedure. | |
Primary | Time required in minutes | A stopwatch will be used to measure the chair-time required to complete the entire dental procedure in minutes. | During the dental procedure. | |
Primary | Heart rate per minute (beat per minute) | Five minutes after the participant is seated on the dental chair, a pulse oximeter (OxyWatch, ChoiceMMed, Hamburg, Germany) will be placed on the right forefinger to record the heart rate per minute. | Baseline before starting the dental procedure and then during the procedure at three-minute intervals until the removal of the isolation system. | |
Primary | Systolic and Diastolic blood pressure in millimeters of mercury (mmHg) | Five minutes after the participant is seated on the dental chair, an automatic blood pressure cuff will be applied to the left upper to record the blood pressure in millimeters of mercury (mmHg). | Baseline before starting the dental procedure and then during the procedure at three-minute intervals until the removal of the isolation system. | |
Primary | Behavioral pain and discomfort | The dental procedure will be videotaped using a high-resolution camera fixed in the clinic. The recorded videos will be used to assess the participants' behavioral pain and discomfort using the Face, Legs, Activity, Cry, Consolability (FLACC) scale two trained and calibrated evaluators independently. | During the dental procedure |
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