Clinical trial NCT06201481: Clinical Success of Anterior and Posterior Crowns in a Group of Children Treated Under General Anesthesia
Official title: Clinical Success of Anterior and Posterior Full Coverage Restorations in a Group of Children Treated Under General Anesthesia: An Incidence Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prosthesis Failure, Dental
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian Children Aged 2-5 years.

Brief summary: * This incidence study aims to evaluate the clinical success of anterior and posterior full-coverage restorations among a group of Egyptian children treated under general anesthesia.
* The main question it aims to answer:

In A Group of Children, What Is the Clinical Success of Anterior and Posterior Full Coverage Restorations Performed Under General Anesthesia?

Detailed description: This study consisted of clinical examinations of the participants treated under general anesthesia to evaluate the clinical success of anterior and posterior crowns that will be performed on the day of the dental treatment, then after 15 days, 3, 6, and 12 months recall examinations.

- The level of parental satisfaction will be evaluated through a questionnaire that will be completed after 15 days, 3, 6, and 12 months.

Eligibility criteria: Inclusion Criteria:

* Children aged between 2 and 5 years old.
* Children classified as American Society of Anesthesiologists class I; Healthy (no acute or chronic disease, normal BMI percentile for age)
* All Children received pulp therapy techniques for vital teeth.

Exclusion Criteria:

* Children with mental or neurological disorders.
* Children with developmental disorders and syndromes.
* Children whose parents have no mobile phone access.

Primary outcomes:
measure: Clinical Success of Stainless-Steel Crowns
timeFrame: Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months
measure: Clinical Success of Anterior Esthetic Crowns
timeFrame: Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months
Secondary outcomes:
measure: Pain score
timeFrame: Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months
Other outcomes:
measure: Level of Parental Satisfaction
timeFrame: After 15 days of the Intervention then after 3 months then after 6 months and after 12 months
Locations:
Study officials:
References:
citation: Schuler IM, Hiller M, Roloff T, Kuhnisch J, Heinrich-Weltzien R. Clinical success of stainless steel crowns placed under general anaesthesia in primary molars: an observational follow up study. J Dent. 2014 Nov;42(11):1396-403. doi: 10.1016/j.jdent.2014.06.009. Epub 2014 Jun 30.
citation: Jiang H, Shen L, Qin D, He S, Wang J. Effects of dental general anaesthesia treatment on early childhood caries: a prospective cohort study in China. BMJ Open. 2019 Sep 9;9(9):e028931. doi: 10.1136/bmjopen-2019-028931.
citation: Sharaf AA, Farsi NM. A clinical and radiographic evaluation of stainless steel crowns for primary molars. J Dent. 2004 Jan;32(1):27-33. doi: 10.1016/s0300-5712(03)00136-2.
citation: MacLean JK, Champagne CE, Waggoner WF, Ditmyer MM, Casamassimo P. Clinical outcomes for primary anterior teeth treated with preveneered stainless steel crowns. Pediatr Dent. 2007 Sep-Oct;29(5):377-81.
citation: Chao Z, Gui Jin H, Cong Y. The effect of general anesthesia for ambulatory dental treatment on children in Chongqing, Southwest China. Paediatr Anaesth. 2017 Jan;27(1):98-105. doi: 10.1111/pan.12983. Epub 2016 Oct 25.