Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06128811
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-11-01
Brief Title:
Dental Isolation Systems Among Pediatric Patients With Different Airway Patency
Sponsor:
King Abdulaziz University
Organization:
King Abdulaziz University
Study Overview
Official Title:
The Use of DryShield and Rubber Dam Isolation Systems Among Pediatric Patients With Different Airway Patency A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Frankls 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
Detailed Description:
This study will aim to evaluate the effect of DryShield isolation system and rubber dam isolation on arterial oxygen saturation heart rate blood pressure behavior subjective pain and discomfort and time required among 6-12-years-old healthy children with different airway patency based on Modified Mallampati classification scores
This split-mouth randomized clinical trial will be conducted in the Pediatric Dentistry Department at King Abdulaziz University Dental Hospital Faculty of Dentistry KAUDH after obtaining ethical approval from the Research Ethics Committee at King Abdulaziz University
Healthy cooperative 6-12-year-old children who need fissure sealants in at least two contralateral fully erupted permanent first molars will be included Children with partially erupted previously restored or carious first molars children with uncooperative behavior during their previous dental treatment children with fixed orthodontic appliances and children with nasal obstruction will be excluded
Children attending the pediatric dentistry clinics during the study period will be screened for eligibility The parents or guardians of eligible children will be approached and given information about the study including the risks benefits and drawbacks If they agree to participate an Arabic consent and assent form will be signed and a treatment appointment will be scheduled The airway patency assessment will be performed during the screening visit by two trained and calibrated dentists using Modified Mallampati classification scores The participants will be asked to sit upright with their chin parallel to the floor open their mouths to the maximum and protrude their tongue without phonation to determine their Modified Mallampati classification score ranging from one to four Class I indicates that the soft palate fauces uvula and tonsillar pillars are clearly visible Class II means the soft palate fauces and the uvula are visible while Class III is when only the soft palate and base of the uvula are visible Finally Class IV is when the soft palate is not visible 13 Participants will be categorized based on their Modified Mallampati classification scores into two groups patent airway Class I and II and non-patent airway Class III and IV
If a participant has more than two contralateral and fully erupted permanent first molars only one pair of molars will be randomly selected to be included in the study
At the scheduled appointment the participants age sex and previous experience with dental isolation will be recorded 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 SpO2 and HR as a baseline and an automatic BP cuff will be applied to the left upper to record the baseline BP The SpO2 HR and BP will be recorded at three-minute intervals until the removal of the isolation system Additionally a stopwatch will measure the chair time required to complete the entire dental procedure The time needed to assemble the RDI or the DSI will not be included Also only topical anesthesia will be applied before RD clamp application
Both fissure sealants will be provided at the same appointment by the same trained and calibrated dentist The Tell-Show-Do behavior management technique will be utilized with all participants 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 and behavior using Frankl behavior classification by two trained and calibrated evaluators independently
For the DSI a pedo-size mouthpiece will be utilized with all the participants After proper isolation fissure sealant Conseal-F TM SDI will be applied following the manufacturers instructions
After the fissure sealant procedure 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 The questionnaire will ask the participants to rate their experience on a numerical scale from zero to 10 with zero meaning no irritating factor at all and 10 indicating presence of irritating factor all the time The factors included noise gagging sensation fluid leak stretching pressure pain and discomfort associated with the isolation system
This split-mouth randomized clinical trial will be conducted in the Pediatric Dentistry Department at King Abdulaziz University Dental Hospital Faculty of Dentistry KAUDH after obtaining ethical approval from the Research Ethics Committee at King Abdulaziz University
Healthy cooperative 6-12-year-old children who need fissure sealants in at least two contralateral fully erupted permanent first molars will be included Children with partially erupted previously restored or carious first molars children with uncooperative behavior during their previous dental treatment children with fixed orthodontic appliances and children with nasal obstruction will be excluded
Children attending the pediatric dentistry clinics during the study period will be screened for eligibility The parents or guardians of eligible children will be approached and given information about the study including the risks benefits and drawbacks If they agree to participate an Arabic consent and assent form will be signed and a treatment appointment will be scheduled The airway patency assessment will be performed during the screening visit by two trained and calibrated dentists using Modified Mallampati classification scores The participants will be asked to sit upright with their chin parallel to the floor open their mouths to the maximum and protrude their tongue without phonation to determine their Modified Mallampati classification score ranging from one to four Class I indicates that the soft palate fauces uvula and tonsillar pillars are clearly visible Class II means the soft palate fauces and the uvula are visible while Class III is when only the soft palate and base of the uvula are visible Finally Class IV is when the soft palate is not visible 13 Participants will be categorized based on their Modified Mallampati classification scores into two groups patent airway Class I and II and non-patent airway Class III and IV
If a participant has more than two contralateral and fully erupted permanent first molars only one pair of molars will be randomly selected to be included in the study
At the scheduled appointment the participants age sex and previous experience with dental isolation will be recorded 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 SpO2 and HR as a baseline and an automatic BP cuff will be applied to the left upper to record the baseline BP The SpO2 HR and BP will be recorded at three-minute intervals until the removal of the isolation system Additionally a stopwatch will measure the chair time required to complete the entire dental procedure The time needed to assemble the RDI or the DSI will not be included Also only topical anesthesia will be applied before RD clamp application
Both fissure sealants will be provided at the same appointment by the same trained and calibrated dentist The Tell-Show-Do behavior management technique will be utilized with all participants 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 and behavior using Frankl behavior classification by two trained and calibrated evaluators independently
For the DSI a pedo-size mouthpiece will be utilized with all the participants After proper isolation fissure sealant Conseal-F TM SDI will be applied following the manufacturers instructions
After the fissure sealant procedure 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 The questionnaire will ask the participants to rate their experience on a numerical scale from zero to 10 with zero meaning no irritating factor at all and 10 indicating presence of irritating factor all the time The factors included noise gagging sensation fluid leak stretching pressure pain and discomfort associated with the isolation system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None