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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-6
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine Restorative Materials and Treatment Methods

    Other intervention

    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.

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Children Undergoing Full-Mouth Dental Rehabilitation Under General Anesthesia1 intervention

Trial outcomes

Primary outcomes

1

Restoration Failure Rate Over 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.

Time frame
Baseline to 24 months

Secondary outcomes

1

Cumulative Restoration Failure Rate According to Restorative Material

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.

Time frame
3, 6, 12, 18, and 24 months
2

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

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.

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

Restoration Failure According to Tooth Type and Location

Evaluation of restoration failure according to tooth type, primary anterior versus posterior teeth, maxillary versus mandibular arch, and other relevant tooth-related characteristics.

Time frame
3, 6, 12, 18, and 24 months
4

Overall Treatment Success Following Full-Mouth Dental Rehabilitation

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

Time frame
24 months

Other outcomes

Sponsors and contacts

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