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NCT Number: NCT07827833

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

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.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

faculty of dentistry, Tanta university

Tanta, Egypt

Location status: Recruiting

Location contact

shaimaa eldesouky, assistant professor

CONTACT

[email protected]

01008994242

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine Restorative Materials and Treatment Methods

Other

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.

Primary outcomes

  1. Restoration Failure Rate Over 24 Months

    Time frame: 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.

Secondary outcomes

  1. Cumulative Restoration Failure Rate According to Restorative Material

    Time frame: 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.

  2. Types of Restoration Failure Assessed Using Modified United States Public Health Service (USPHS/Ryge) Criteria

    Time frame: 3, 6, 12, 18, and 24 months

    Frequency and distribution of restoration failure modes assessed according to the modified United States Public Health Service (USPHS/Ryge) criteria. Failure modes include recurrent caries, loss of restoration retention, restoration fracture, marginal deterioration, excessive wear, and the need for repair, replacement, or retreatment. Restorations will be evaluated using USPHS ratings (Alpha, Bravo, Charlie, and Delta), where Alpha represents ideal clinical performance and Charlie/Delta ratings indicate clinically unacceptable conditions requiring intervention or replacement.

  3. Restoration Failure According to Tooth Type and Location

    Time frame: 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.

  4. Overall Treatment Success Following Full-Mouth Dental Rehabilitation

    Time frame: 24 months

    Proportion of children completing the 24-month follow-up without major treatment failure requiring additional operative dental treatment under general anesthesia.

Study contacts

Contact information is provided by the study sponsor or research team.

nancy metwally, assistant professor

CONTACT

[email protected]

01225146945

shaimaa eldesouky

CONTACT

[email protected]

01008994242

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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