Does Treating Early Childhood Caries Under Local or General Anesthesia Have Varying Effects on OHRQoL
Condition: Oral Health Related Quality of Life OHRQoL
Study type: Interventional

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.
    

Detailed description: 
      Ethical Approval:

      The study proposal was registered with the research center at Riyadh Elm University (REU),
      Riyadh, Saudi Arabia, and ethical approval was obtained from the institutional review board
      (IRB). Informed consent was obtained from the parents of all participants and the data was
      managed such that complete confidentiality of the patient was maintained. The current study
      abides by the regulations presented at the Helsinki declaration.

      Sample size calculation:

      The sample size required to reject the null hypothesis was estimated using the data from a
      previous study42 wherein 33.3% of the children with treatment under DGA were reported with
      better OHRQoL in contrast to 3.3% in the control group. With the alpha set at 0.05, the 80%
      power of study, and the addition of 30% dropout rate, a sample size of a minimum of 50
      children in each group was estimated.

      Sample selection criteria:

      Arab children aged six years or younger, who were recommended for comprehensive dental
      treatment at Riyadh Elm university hospitals (Munseah and Numthjiah campuses) by pediatric
      dentistry residents, and who consented to be part of the study were recruited. Before
      subjecting the recruited participants to randomization, the intraoral findings were
      documented, radiographs were taken, and a plan of treatment was designed. Children with
      systemic disease, physical and mental disability, and congenital defect such as amelogenesis
      imperfecta or cleft lift/palate were excluded.

      Study variables:

      The OHRQoL was measured using the Arabic version of the Early childhood impact scale
      ECOHIS.35 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.35 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. Lower scores indicated better OHRQoL

      Explanatory variables:

      The primary explanatory variable was the administration of local or general anesthesia to
      perform the comprehensive dental treatment which included pulp therapy, restoration, and
      extraction of primary teeth. Age and gender of children, family socio-economic status,
      parent's education level, dental index "dft" decayed and filled teeth, along with fractured
      and traumatized teeth were also recorded. The details related to clinical examination, dental
      history, and treatment provided were recorded from the electronic file system "DENTPLUS" at
      REU hospitals. The average number of dental visits was required to finish the treatment plan
      in LA group around five to six while in GA group the treatment was provided as a day care
      surgery for healthy child patients.

      Data collection process:

      The data collection was carried out from April 2021 to January 2022. During the Child's first
      appointment, an oral examination was conducted, followed by a comprehensive treatment plan.
      Additionally, the child's behavior was assessed using the Frankel behavior rating scale
      before subjecting them to randomization.Each eligible child with no behavioral issues was
      subjected to a flip coin randomization process and assigned accordingly into the LA or DGA
      group. The process of flip coin method to assign the children into two groups was carried out
      until one group reached the required sample size of 50, and then the remaining eligible
      children were assigned to the subsequent group. Importantly, therapy under LA was planned for
      children whose parents were fearful and did not consent for DGA. Also, therapy under DGA was
      planned for children whose parents wanted to complete the treatment in a single session.
      These children who could not be subjected to randomization process were treated but not
      included in the study.

      In this study, due to obvious reasons, the child-parent duo and the primary investigator
      performing the dental treatment could not be blinded to the intervention. However, to
      somewhat follow the blinding process, the primary investigator asked a trained dental
      auxiliary staff, who was not part of the study, to administer the ECOHIS questionnaire and
      collect the socio-demographic data. This process where the primary investigator was blinded
      to the assessment of the outcome variable was followed at the baseline, one week, and
      one-month data collection timelines. The person carrying out the statistical analyses was
      blinded to the intervention and the outcome assessment. All the data was first entered in the
      Microsoft Excel and then transferred to SPSS version 24 (IBM, USA) for data analyses.
    

Intervention name(s): Dental treatment
Intervention type(s): Procedure
Intervention description(s): Children treated for ECC under general (DGA) and local anesthesia (LA).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early Childhood Caries; Children; Oral Health-Related Quality of Life; OHRQoL; Dental General Anesthesia; Local Anesthesia