Dental Isolation Systems Among Pediatric Patients With Different Airway Patency

NCT06128811 | Unknown

• 1 other identifier: 134-11-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Airway Obstruction; Pain; Behavior

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Participants who will receive rubber dam isolation followed by DryShieled will be considered group 1.

Device: Rubber Dam Isolation; Device: DryShieled isolation; Other: fissure sealant

Group 2

ACTIVE COMPARATOR

Participants who will receive DryShieled followed by rubber dam isolation will be considered group 2.

Device: Rubber Dam Isolation; Device: DryShieled isolation; Other: fissure sealant

Interventions

Rubber Dam Isolation DEVICE

Rubber dam isolation will be placed using a proper size dental clamp on the first permanent molar after topical anesthesia application.

Group 1; Group 2

DryShieled isolation DEVICE

For the DryShieled isolation, a pedo-size mouthpiece will be utilized with all the participants.

Group 1; Group 2

fissure sealant OTHER

After proper isolation, fissure sealant (Conseal-F TM SDI) will be applied following the manufacturer's instructions, and the quality of the applied fissure sealant will be checked with an explorer. An additional layer will be applied if any deficiency is detected

Group 1; Group 2

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy
• Cooperative
• year-old children
• Who need fissure sealants in at least two contralateral fully erupted permanent first molar

You may not qualify if:

• Children with partially erupted, previously restored, or carious first molars.
• Children with uncooperative behavior during their previous dental treatment.
• Children with fixed orthodontic appliances
• Children with nasal obstruction

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King AbdulAziz University

Jeddah, 21589, Saudi Arabia

Location

MeSH Terms

Conditions

Airway Obstruction; Pain; Behavior

Interventions

Pit and Fissure Sealants

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Sara M Bagher, Mater

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara M Bagher, Master

CONTACT

00966547433525; sbagher@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The statistician will be blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: It is a split-mouth randomized clinical trial. And both sides fissure sealants will be provided at the same appointment by the same trained and calibrated dentist

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 13, 2023
• Study Start: November 15, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)