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

NCT06201481 | Not Yet Recruiting DMC

• 1 other identifier: Success in Dental GA
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Prosthesis Failure, Dental

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pain score

  Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months

Other Outcomes (1)

• Level of Parental Satisfaction

  After 15 days of the Intervention then after 3 months then after 6 months and after 12 months

Interventions

anterior and posterior full coverage crowns PROCEDURE

Teeth preparation,crown fitting and cementation

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Egyptian Children Aged 2-5 years.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (5)

• 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.

  PMID: 24994618 BACKGROUND

• 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.

  PMID: 31501107 RESULT

• 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.

  PMID: 14659715 RESULT

• 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.

  PMID: 18027771 RESULT

• 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.

  PMID: 27779347 RESULT

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Salma Sayed, B.D.S

CONTACT

01066364181; salmasayed25@gmail.com

Hanaa Abdelmoniem, PhD

CONTACT

01001081614

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 11, 2024
• Study Start: August 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: October 1, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06