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

NCT07827833 | Recruiting DMC

• 1 other identifier: #R-PED-7-25-3211
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Dental General Anesthesia; Restoration; Full Mouth Rehabilitation; Clinical Performance

Keywords

General Anesthesia; Full-Mouth Dental Rehabilitation; Restorative Materials; restoration Failure; Early Childhood Caries

Outcome Measures

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.

  Baseline to 24 months

Secondary Outcomes (4)

• Cumulative Restoration Failure Rate According to Restorative Material

  3, 6, 12, 18, and 24 months

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

  3, 6, 12, 18, and 24 months

• Restoration Failure According to Tooth Type and Location

  3, 6, 12, 18, and 24 months

• Overall Treatment Success Following Full-Mouth Dental Rehabilitation

  24 months

Study Arms (1)

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.

Other: Routine Restorative Materials and Treatment Methods

Interventions

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.

Children Undergoing Full-Mouth Dental Rehabilitation Under General Anesthesia

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of dentistry, Tanta university

Tanta, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 33833801 RESULT

• 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.

  PMID: 11874065 RESULT

• 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.

  PMID: 37954807 RESULT

Study Officials

• shaimaa S eldesouky

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shaimaa eldesouky

CONTACT

01008994242; shaimaaeldesouky@dent.tanta.edu.eg

nancy metwally, assistant professor

CONTACT

01225146945; nancy.mohamed@dent.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of pediatric dentistry

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: August 3, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

EG (1)