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Not yet recruitingNCT06201481Updated Jun 27, 2024

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

An observational study in Prosthesis Failure, Dental, sponsored by Cairo University. Not yet recruiting. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
2 Years to 5 Years
Sex
All
01

Study 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?

Read the 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.
02

Conditions studied

  • Prosthesis Failure, Dental

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03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 100 is below the median of 119 across 49 observational studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Egyptian Children Aged 2-5 years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Children with mental or neurological disorders.
  • Children with developmental disorders and syndromes.
  • Children whose parents have no mobile phone access.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Procedureanterior and posterior full coverage crowns

    Teeth preparation,crown fitting and cementation

06

What researchers measure

Primary outcomes

  1. Clinical Success of Stainless-Steel Crowns

    Clinical evaluation criteria: * crown marginal adaptation * crown marginal extension crown proximal contact * duration of crown presence

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

  2. Clinical Success of Anterior Esthetic Crowns

    Clinical evaluation criteria: * crown retention * crown chipping * opposing wear

    Time frame: 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

    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)

    Time frame: 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

    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?

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24994618 ↗
  • 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. PubMed 31501107 ↗
  • 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. PubMed 14659715 ↗
  • 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. PubMed 18027771 ↗
  • 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. PubMed 27779347 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2024; primary completion for Aug 2025, 12 months later.

Of 28 observational studies under Prosthesis Failure, half reached primary completion within 181 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 184. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2023
First posted
Jan 11, 2024
StartEst.
Aug 1, 2024
Primary completionEst.
Aug 30, 2025
CompletionEst.
Oct 2025
Last update
Jun 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06201481
Lead sponsor
Cairo University
Responsible party
Salma Sayed Ali Ebrahim (Principal Investigator, Cairo University) — Principal investigator
First posted
Jan 11, 2024
Start date
Aug 1, 2024 (estimated)
Primary completion
Aug 30, 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Jun 27, 2024

Study contacts

Salma Sayed, B.D.S
Contact
salmasayed25@gmail.com
01066364181
Hanaa Abdelmoniem, PhD
Contact
01001081614

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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