NCT05761691

Brief Summary

A two-arm randomized control trial is to compare the changes in OHRQoL scores among children treated for ECC under general (DGA) and local anesthesia (LA). Outcome variable was OHRQoL, measured using the early childhood oral health impact scale ECOHIS and explanatory variable was the administration of local or general anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

February 27, 2023

Last Update Submit

March 9, 2023

Conditions

Oral Health Related Quality of Life OHRQoL

Keywords

Early Childhood CariesChildrenOral Health-Related Quality of LifeOHRQoLDental General AnesthesiaLocal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Oral health related quality of life OHRQoL

    Oral health related quality of life OHRQoL was measured using the Arabic version of the Early childhood impact scale ECOHIS. This scale has 13 questions and is divided into the child and family impacts. The child impact part includes nine questions under four fields: child OH symptoms, function, psychology and self-image, and social interaction while the family impact part contains four questions under two domains: parental distress and family function. Parents responded to the questions on a 6-point Likert scale (0, never; 1, hardly ever; 2, occasionally; 3, often; 4, very often; and 5, do not know). The overall score was calculated by summing the scores of each item and domain separately with maximum value at (65) . Lower scores indicated better OHRQoL

    One year

Study Arms (2)

Children treated for Early childhood caries under general anesthesia (DGA)

EXPERIMENTAL

GA group (Study group) the dental treatment was provided as a day care surgery under general anasthesia for healthy child patients.

Procedure: Dental treatment

Children treated for Early childhood caries under Local anesthesia (LA)

EXPERIMENTAL

LA goup (control group) the average number of dental visits was required to finish the treatment plan in local anasthesia group around five to six visits.

Procedure: Dental treatment

Interventions

Dental treatmentPROCEDURE

Children treated for ECC under general (DGA) and local anesthesia (LA).

Children treated for Early childhood caries under Local anesthesia (LA)Children treated for Early childhood caries under general anesthesia (DGA)

Eligibility Criteria

Age2 Years - 6 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale \& Female
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Arab children
  • Age six years or younger

You may not qualify if:

  • Children systemic disease
  • Children with physical and mental disability
  • Children with congenital dental defect such as amelogenesis imperfecta
  • Children with cleft lift/palate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riyadh Elm University

Riyadh, Saudi Arabia

Location

Related Publications (1)

  • Alwadani MA, Alsulaiman DA, Kakti A, Alamoudi S, Tadakamadla SK, Quadri MFA. Comparison of Oral Health-Related Quality of Life scores in children treated for early childhood caries under general and local anesthesia: a quasi-experimental study. Eur Arch Paediatr Dent. 2023 Dec;24(6):719-728. doi: 10.1007/s40368-023-00835-w. Epub 2023 Aug 29.

    PMID: 37644356DERIVED

MeSH Terms

Interventions

Dental Care

Intervention Hierarchy (Ancestors)

DentistryDental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mohammad Alwadaani, MSc

    Riyadh Elm University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two armed RCT was planned. First: children received dental treatment under general anesthesia (Study group) Second: Children received dental treatment under local anesthesia (Control group) in regular dental sitting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Dental Resident

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

February 1, 2021

Primary Completion

January 1, 2022

Study Completion

March 1, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)