Prosthesis Failure, DentalNCT06201481
Clinical Success of Anterior and Posterior Crowns in a Group of Children Treated Under General Anesthesia
An observational study of Prosthesis Failure, Dental, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Failure, Dental
- What is being tested?
- anterior and posterior full coverage crowns
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Egyptian Children Aged 2-5 years.
Who may be able to join
- 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.
Who cannot join
- Children with mental or neurological disorders.
- Children with developmental disorders and syndromes.
- Children whose parents have no mobile phone access.
Trial locations and contacts
No sites are listed yet.
Hanaa Abdelmoniem, PhD contact
About this study
Official title: 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?
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.
- Conditions
- Prosthesis Failure, Dental
- Being tested
- anterior and posterior full coverage crowns
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior and posterior full coverage crownsProcedure or surgery
Teeth preparation,crown fitting and cementation
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success of Stainless-Steel Crowns
Clinical evaluation criteria:
- crown marginal adaptation
- crown marginal extension crown proximal contact
- duration of crown presence
Measured: 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
Measured: 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)
Measured: Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prosthesis Failure, DentalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Sayed Ali Ebrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201481
- Sponsor's protocol ID
- Success in Dental GA
- Status last verified
- Jun 2024
- First submitted
- 16 Dec 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 24994618Jiang 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 31501107Sharaf 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 14659715MacLean 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 18027771Chao 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Success of Anterior and Posterior Full Coverage Restorations in a Group of Children Treated Under General Anesthesia: An Incidence Study
- ClinicalTrials.gov ID
- NCT06201481
- Acronym / sponsor ID
- Success in Dental GA
- Conditions
- Prosthesis Failure, Dental
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Egyptian Children Aged 2-5 years.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Children with mental or neurological disorders.
- Children with developmental disorders and syndromes.
- Children whose parents have no mobile phone access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior and posterior full coverage crownsTeeth preparation,crown fitting and cementation | Procedure or surgery | – |
Primary outcome
Clinical Success of Stainless-Steel Crowns
Time frame: Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months
Clinical evaluation criteria: * crown marginal adaptation * crown marginal extension crown proximal contact * duration of crown presence
Clinical Success of Anterior Esthetic Crowns
Time frame: Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months
Clinical evaluation criteria: * crown retention * crown chipping * opposing wear
1 secondary outcome
Pain score
Time frame: Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 24994618Schuler 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.
- Results publication: PubMed 31501107Jiang 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.
- Results publication: PubMed 14659715Sharaf 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.
- Results publication: PubMed 18027771MacLean 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.
- Results publication: PubMed 27779347Chao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanaa Abdelmoniem, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthesis Failure, Dental, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salma Sayed, B.D.S (01066364181, salmasayed25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success of Stainless-Steel Crowns (time frame: Immediately after the intervention then after 15 days then after 3 months then after 6 months and after 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06201481, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.