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Dental Isolation Systems Among Pediatric Patients With Different Airway Patency

NCT06128811 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-13

No results posted yet for this study

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

Interventions

DEVICE

Rubber Dam Isolation

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

DEVICE

DryShieled isolation

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

OTHER

fissure sealant

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

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Principal Investigators

  • Sara M Bagher, Mater · Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2023-12-30
Completion
2024-01-30

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128811 on ClinicalTrials.gov