Skip to content

Comparative Effectiveness of Conventional and Porter Silhouette Nasal Masks for Nitrous Oxide and Oxygen Conscious Inhalation Sedation in Pediatric Dentistry: A Non-Inferiority Randomized Controlled Crossover Trial

Comparative Effectiveness of Conventional and Porter Silhouette Nasal Masks for Nitrous Oxide and Oxygen Conscious Inhalation Sedation in Pediatric Dentistry: A Non-Inferiority Randomized Controlled Crossover Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251124010
Enrollment
53
Registered
2025-11-24
Start date
2025-10-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effectiveness of Conventional and Porter Silhouette Nasal Masks for Nitrous Oxide and Oxygen Conscious Inhalation Sedation in Pediatric Dentistry Nitrous oxide and oxygen, Inhalation sedation , Double mask, Porter Silhouette Masks, Pediatric patient, Patient satisfaction

Interventions

A conventional nasal mask will be applied for patients undergoing dental treatment under nitrous oxide inhalation sedation. The effectiveness of NOIS will be assessed using the Houpt Behavior Rating S
Experimental Device,Experimental Device
Conventional double nasal mask,Porter Silhouette nasal mask

Sponsors

Research fund for postgraduate student of Faculty of Dentistry, Chiang Mai university, Chiang Mai, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 3-12 years , classified as ASA Class I, II, who are scheduled to undergo dental treatment under NOIS and require a minimum of two appointment.

Exclusion criteria

Exclusion criteria: 1.Children younger than 3 years or older than 12 years 2.Children classified as ASA class III or higher 3.Children receiving dental treatment using conventional methods, NOIS combined with oral sedatives, or general anesthesia 4.Children with a latex allergy 5.Children undergoing dental treatment under NOIS whose parents or legal guardians do not consent to participate in the study

Design outcomes

Primary

MeasureTime frame
The effectiveness of nitrous oxide sedation inhalation 10-60 mins Using the Houpt Behavior Rating Scale,

Secondary

MeasureTime frame
Pateint satisfaction 5- 10 seconds Using Smiley Likert scale

Countries

Thailand

Contacts

Public ContactNattakan Chaipattanawan

Faculty of Dentistry, Chiang Mai university, Chiang Mai, Thailand

nattakan.chai@cmu.ac.th053944460

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026