Clinical Success of Anterior and Posterior Crowns in a Group of Children Treated Under General Anesthesia

Clinical Success of Anterior and Posterior Full Coverage Restorations in a Group of Children Treated Under General Anesthesia: An Incidence Study

• 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?

Study Overview

• Status: Not yet recruiting
• Conditions: Prosthesis Failure, Dental
• Intervention / Treatment: Procedure: anterior and posterior full coverage crowns

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Salma Sayed, B.D.S; Phone Number: 01066364181; Email: salmasayed25@gmail.com
• Study Contact Backup: Name: Hanaa Abdelmoniem, PhD; Phone Number: 01001081614

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Egyptian Children Aged 2-5 years.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success of Stainless-Steel Crowns	Clinical evaluation criteria: crown marginal adaptation; crown marginal extension crown proximal contact; duration of crown presence	Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months
Clinical Success of Anterior Esthetic Crowns	Clinical evaluation criteria: crown retention; crown chipping; opposing wear	Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain will be evaluated by scores using a five-point scale.; None (If the parents give a score 1); Mild (If the parents give a score 2); Moderate (If the parents give a score 3); Sever (If the parents give a score 4 or 5)	Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Parental Satisfaction	A questionnaire will measure the level of parental satisfaction. - Questions will be answered by YES or NO . The questions : Received enough information before treatment?; Knew where and how to access help after treatment?; Regarded this treatment to be positive?; Overall experience is satisfactory?; Would consider general anesthesia for treatment again?	After 15 days of the Intervention then after 3 months then after 6 months and after 12 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 16, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: Success in Dental GA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No