Clinical Performance and Failure Rates of Restorations Following Pediatric Dental Rehabilitation Under General Anesthesia
Clinical Outcomes and Failure Rates of Restorative Treatments Following Full-Mouth Dental Rehabilitation Under General Anesthesia in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Early childhood caries and extensive dental disease remain significant oral health problems among children worldwide. In many cases, comprehensive dental treatment under general anesthesia (GA) is required to manage young children who exhibit extensive treatment needs, lack of cooperation, dental anxiety, behavioral limitations, or special healthcare needs. Full-mouth dental rehabilitation under GA enables the delivery of comprehensive restorative and preventive dental care in a single session, improving oral health and quality of life for affected children. A variety of restorative materials and treatment methods are routinely employed during pediatric dental rehabilitation under GA, including resin composite restorations, glass ionomer-based restorations, stainless steel crowns, esthetic full-coverage crowns, and restorations associated with pulp therapy procedures. Despite their widespread use, the long-term clinical performance and survival of these restorative approaches may vary according to material characteristics, tooth type, extent of carious destruction, patient-related factors, and oral hygiene practices. Restoration failure may result from recurrent caries, loss of restoration, marginal deterioration, fracture, wear, or the need for replacement or retreatment.
Although several studies have evaluated restorative outcomes in pediatric patients, evidence comparing the long-term success and failure rates of restorative materials and techniques used during full-mouth dental rehabilitation under GA remains limited. Furthermore, most available studies have reported variable follow-up periods and heterogeneous outcome measures, making it difficult to establish evidence-based recommendations for restorative treatment selection.
The purpose of this prospective cohort study is to evaluate the clinical outcomes and failure rates of restorative materials and methods employed during children's full-mouth dental rehabilitation under general anesthesia over a two-year follow-up period. Children receiving comprehensive dental treatment under GA will be enrolled and monitored at predetermined follow-up intervals. Clinical assessments will evaluate restoration survival, retention, marginal integrity, recurrent caries, restoration fracture, need for repair or replacement, and overall treatment success. The cumulative survival and failure rates of different restorative materials and treatment methods will be determined, and factors associated with restoration longevity will be investigated.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: shaimaa eldesouky
- Phone Number: 01008994242
- Email: shaimaaeldesouky@dent.tanta.edu.eg
Study Contact Backup
- Name: nancy metwally, assistant professor
- Phone Number: 01225146945
- Email: nancy.mohamed@dent.tanta.edu.eg
Study Locations
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Tanta, Egypt
- Recruiting
- faculty of dentistry, Tanta university
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Contact:
- shaimaa eldesouky, assistant professor
- Phone Number: 01008994242
- Email: shaimaaeldesouky@dent.tanta.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children requiring comprehensive/full-mouth dental rehabilitation under general anesthesia because of extensive dental treatment needs.
- Children receiving restorative and/or full-coverage dental treatments as part of routine clinical care.
- Children whose parents provide written informed consent for participation and follow-up.
- Children whose planned treatment allows clinical evaluation of the restorations for the intended 24-month follow-up period.
- Children whose parents or legal guardians are willing and able to attend the scheduled follow-up visits for up to 24 months.
Exclusion Criteria:
- Children for whom the planned dental rehabilitation cannot be completed because of medical or anesthetic considerations.
- Children with systemic or medical conditions that are expected to substantially affect oral healing, caries progression, or restoration survival.
- Children unlikely to attend or complete the scheduled 24-month follow-up.
- Children with inadequate clinical records or insufficient baseline information required for assessment of restoration outcomes.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Children Undergoing Full-Mouth Dental Rehabilitation Under General Anesthesia
Children undergoing full-mouth dental rehabilitation under general anesthesia as part of routine clinical care will be prospectively enrolled and followed for 24 months.
Restorative materials and treatment methods will be selected by the treating clinicians according to the child's clinical condition, tooth type, extent of caries, remaining tooth structure, pulp status, and standard clinical indications.
No restorative material or treatment method will be assigned by the study investigators.
The clinical performance, survival, and failure of restorations placed during routine treatment will be evaluated at scheduled follow-up visits over a two-year period.
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Restorative materials and treatment methods routinely employed during full-mouth dental rehabilitation under general anesthesia, including direct restorations and full-coverage restorations such as composite resin restorations, glass ionomer-based restorations, stainless steel crowns, and other clinically indicated restorative approaches.
The selection of restorative material and treatment method will be determined by the treating clinician according to the child's clinical needs and standard clinical practice.
The study investigators will not assign or randomize participants to any restorative material or treatment method.
These restorative treatments will be observed prospectively to evaluate their clinical performance, survival, and failure rates over a 24-month follow-up period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Restoration Failure Rate Over 24 Months
Time Frame: Baseline to 24 months
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The proportion of restorations that experience failure during the 24-month follow-up period.
Restoration failure will include recurrent caries, loss or debonding of the restoration, fracture, unacceptable marginal deterioration, or the need for restoration replacement, repair, or retreatment.
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Baseline to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cumulative Restoration Failure Rate According to Restorative Material
Time Frame: 3, 6, 12, 18, and 24 months
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Comparison of cumulative failure rates among the restorative materials routinely used during rehabilitation, such as composite resin, glass ionomer-based restorations, stainless steel crowns, and other clinically indicated restorative materials.
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3, 6, 12, 18, and 24 months
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Types of Restoration Failure
Time Frame: 3, 6, 12, 18, and 24 months
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Frequency and distribution of different failure modes, including recurrent caries, restoration loss, fracture, marginal deterioration, wear, and need for repair, replacement, or retreatment.
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3, 6, 12, 18, and 24 months
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Restoration Failure According to Tooth Type and Location
Time Frame: 3, 6, 12, 18, and 24 months
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Evaluation of restoration failure according to tooth type, primary anterior versus posterior teeth, maxillary versus mandibular arch, and other relevant tooth-related characteristics.
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3, 6, 12, 18, and 24 months
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Overall Treatment Success Following Full-Mouth Dental Rehabilitation
Time Frame: 24 months
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Proportion of children completing the 24-month follow-up without major treatment failure requiring additional operative dental treatment under general anesthesia.
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24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: shaimaa S eldesouky, Tanta University
Publications and helpful links
General Publications
- Alhissan AS, Pani SC. Factors Influencing the Survival of Preformed Zirconia Crowns in Children Treated under General Anesthesia. Int J Dent. 2021 Mar 17;2021:5515383. doi: 10.1155/2021/5515383. eCollection 2021.
- Tate AR, Ng MW, Needleman HL, Acs G. Failure rates of restorative procedures following dental rehabilitation under general anesthesia. Pediatr Dent. 2002 Jan-Feb;24(1):69-71.
- Mathew MG, Jeevanandan G. Evaluation of Factors Affecting Clinical Outcomes of Full Mouth Rehabilitation Under General Anaesthesia for Children With Early Childhood Caries: A Prospective Cohort Study. Cureus. 2023 Oct 10;15(10):e46778. doi: 10.7759/cureus.46778. eCollection 2023 Oct.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- #R-PED-7-25-3211
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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