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Clinical Performance and Failure Rates of Restorations Following Pediatric Dental Rehabilitation Under General Anesthesia

14. september 2026 opdateret af: Shaimaa Shaban Mohamed El-desouky, Tanta University

Clinical Outcomes and Failure Rates of Restorative Treatments Following Full-Mouth Dental Rehabilitation Under General Anesthesia in Children

Full-mouth dental rehabilitation under general anesthesia (GA) is frequently required for young children with extensive dental caries, behavioral challenges, or special healthcare needs. Although various restorative materials and treatment approaches are used during comprehensive dental rehabilitation, evidence regarding their long-term clinical performance and failure rates remains limited. Objective: This prospective cohort study aims to evaluate the clinical outcomes and failure rates of restorative materials and methods employed during full-mouth dental rehabilitation under general anesthesia in children over a two-year follow-up period. Methods: Children undergoing full-mouth dental rehabilitation under general anesthesia will be enrolled and followed prospectively for 24 months. Restorative procedures, including direct and indirect restorative treatments, pulp therapy-associated restorations, and full-coverage restorations, will be performed according to standardized clinical protocols. Clinical evaluations will be conducted at scheduled follow-up visits to assess restoration survival, integrity, recurrent caries, need for retreatment, and restoration failure. Failure rates and factors associated with restoration success or failure will be analyzed.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

180

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will consist of children aged 3-6 years who require comprehensive full-mouth dental rehabilitation under general anesthesia because of extensive dental caries and/or extensive restorative treatment needs. Participants will receive restorative and full-coverage dental treatments as part of routine clinical care, with the selection of restorative materials and treatment methods determined by the treating clinician according to the child's clinical needs. Participants will be prospectively followed for 24 months to evaluate the clinical performance, survival, and failure rates of the restorations placed during dental rehabilitation.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Restoration Failure Rate Over 24 Months
Tidsramme: Baseline to 24 months
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.
Baseline to 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative Restoration Failure Rate According to Restorative Material
Tidsramme: 3, 6, 12, 18, and 24 months
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.
3, 6, 12, 18, and 24 months
Types of Restoration Failure
Tidsramme: 3, 6, 12, 18, and 24 months
Frequency and distribution of different failure modes, including recurrent caries, restoration loss, fracture, marginal deterioration, wear, and need for repair, replacement, or retreatment.
3, 6, 12, 18, and 24 months
Restoration Failure According to Tooth Type and Location
Tidsramme: 3, 6, 12, 18, and 24 months
Evaluation of restoration failure according to tooth type, primary anterior versus posterior teeth, maxillary versus mandibular arch, and other relevant tooth-related characteristics.
3, 6, 12, 18, and 24 months
Overall Treatment Success Following Full-Mouth Dental Rehabilitation
Tidsramme: 24 months
Proportion of children completing the 24-month follow-up without major treatment failure requiring additional operative dental treatment under general anesthesia.
24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: shaimaa S eldesouky, Tanta University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. august 2025

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

14. september 2026

Først indsendt, der opfyldte QC-kriterier

14. september 2026

Først opslået (Faktiske)

18. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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