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Repair Versus Replacement of Failed Restorations in Primary Teeth

4 settembre 2026 aggiornato da: Tamara Kerber Tedesco, University of Sao Paulo

Repair Versus Replacement of Failed Restorations in Primary Teeth: Protocol for a Non-Inferiority Randomized Clinical Trial

Dental caries affect approximately 573 million children globally, and the management of failed restorations is a frequent clinical issue in pediatric dentistry. Although complete replacement of restorations is traditionally the most commonly adopted approach, repair represents a minimally invasive alternative that preserves healthy dental structure and reduces the risk of pulpal complications. Studies in permanent teeth demonstrate that repair may present longevity similar to replacement; however, there is no robust evidence regarding this comparison in primary teeth. This randomized controlled clinical trial, with parallel groups and a 1:1 allocation ratio, aims to evaluate the non-inferiority of repair compared with replacement of failed restorations in primary molars, using encapsulated high-viscosity glass ionomer cement. Children aged 4 to 8 years with at least one failed restoration eligible for repair in primary molars will be included. Randomization will be stratified by number of surfaces. Teeth (n=824) will be randomly allocated to one of the groups: repair or replacement. The primary outcome will be restoration survival at 24 months. Cost-effectiveness will be evaluated as a secondary outcome. Statistical analysis will use Kaplan-Meier curves and Cox regression with shared frailty (¿=5%).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

382

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Tamara K Tedesco, PhD
Numero di telefono: +5511954866622
Email: tamarakt@usp.br

Luoghi di studio

Brasile
- São Paulo
  - São Paulo, São Paulo, Brasile, 05508-000
    - University of São Paulo, School of Dentistry
    - Contatto:
      
      Tamara K Tedesco, PhD
      
      Numero di telefono: +5511954866622
      
      Email: tamarakt@usp.br
    - Contatto:
      
      Camila C Cabral, PhD
      
      Numero di telefono: +5511996254588
      
      Email: camila.cabral@usp.br
    - Sub-investigatore:
      
      Aline S Gusmão, DDS

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Bambino

Accetta volontari sani

Descrizione

Inclusion Criteria:

Children aged 4 to 8 years;
Presence of at least one defective restoration in a primary molar, involving no more than 3 surfaces;
Absence of clinical and radiographic signs of pulp involvement;

Exclusion Criteria:

Tooth without pulp vitality or requiring endodontic treatment;
Loose or mobile restoration;
Presence of fistula, abscess, or history of pain;
Tooth mobility incompatible with the physiological exfoliation timeline;
Parents/guardians who do not consent to participation by signing the ICF, or children who do not assent to participate in the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: Repair Repair of Failed restoration in primary teeth.	Procedura: Repair of Failed Restoration Prior to the procedure, when needed, local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be used, with relative isolation (cotton rolls and saliva ejector). The defective area will be clinically identified. When present, carious tissue will be selectively removed with hand instruments (dentin curettes) suited to the cavity, preserving as much of the intact original restoration as possible. If no hand instrument fits, the cavity will be enlarged with a small spherical diamond bur at high speed under cooling. The surface will be conditioned with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsed abundantly, and dried with cotton pellets. For proximal surfaces, a metal matrix and wedge will be placed before the GIC. The capsule will be activated, mixed for 10 s, inserted with an applicator, and adapted by digital pressure with petroleum jelly. Occlusion will be checked with articulating paper and adjusted; surface protection applied with petroleum jelly.
Comparatore attivo: Replacement Replacement of Failed Restoration in primary teeth.	Procedura: Replacement of Failed Restoration Prior to the procedure, when needed, infiltrative local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be administered. Relative isolation will be used, with cotton rolls and a saliva ejector. Complete removal of the defective restorative material will be performed with spherical diamond burs at high speed under cooling, complemented by round burs at low speed to remove remaining restorative material. Selective removal of carious tissue, when present, will be carried out with hand instruments (dentin curettes) suited to the cavity, preserving soft or leathery dentin according to the depth of the lesion. The new restoration will then be placed following the same protocol described for the repair group: conditioning with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsing and removal of excess water; placement of a metal matrix and wedge, when needed; insertion of the GIC into the cavity; adaptation by digital pressure with petroleum jelly; occlusal adjustment; a

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: Repair

Repair of Failed restoration in primary teeth.

Procedura: Repair of Failed Restoration

Prior to the procedure, when needed, local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be used, with relative isolation (cotton rolls and saliva ejector). The defective area will be clinically identified. When present, carious tissue will be selectively removed with hand instruments (dentin curettes) suited to the cavity, preserving as much of the intact original restoration as possible. If no hand instrument fits, the cavity will be enlarged with a small spherical diamond bur at high speed under cooling. The surface will be conditioned with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsed abundantly, and dried with cotton pellets. For proximal surfaces, a metal matrix and wedge will be placed before the GIC. The capsule will be activated, mixed for 10 s, inserted with an applicator, and adapted by digital pressure with petroleum jelly. Occlusion will be checked with articulating paper and adjusted; surface protection applied with petroleum jelly.

Comparatore attivo: Replacement

Replacement of Failed Restoration in primary teeth.

Procedura: Replacement of Failed Restoration

Prior to the procedure, when needed, infiltrative local anesthesia with 2% lidocaine and 1:100,000 epinephrine will be administered. Relative isolation will be used, with cotton rolls and a saliva ejector. Complete removal of the defective restorative material will be performed with spherical diamond burs at high speed under cooling, complemented by round burs at low speed to remove remaining restorative material. Selective removal of carious tissue, when present, will be carried out with hand instruments (dentin curettes) suited to the cavity, preserving soft or leathery dentin according to the depth of the lesion. The new restoration will then be placed following the same protocol described for the repair group: conditioning with 20% polyacrylic acid (GC Cavity Conditioner) for 10 s, rinsing and removal of excess water; placement of a metal matrix and wedge, when needed; insertion of the GIC into the cavity; adaptation by digital pressure with petroleum jelly; occlusal adjustment; a

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Restoration survival Lasso di tempo: 24 months	Restoration survival will be assessed based on clinical evaluation of the restorations at 6, 12, 18, and 24 months. A restoration will be considered to have survived when it remains clinically satisfactory according to the following criteria. Single-surface restorations will be considered satisfactory when scored as 0 (restoration present and satisfactory), 1 (restoration present, with a slight marginal defect and/or surface wear of less than 0.5 mm in depth, with no need for repair), or 7 (restoration present, with gradual wear involving larger areas of the restoration but less than 0.5 mm in depth at the deepest point, with no need for repair), according to Frencken et al. (1996). Multiple-surface restorations will be considered satisfactory when scored as 00 (restoration present and satisfactory) or 10 (restoration present, with a slight marginal defect and/or surface wear of less than 0.5 mm in depth, with no need for repair), according to Rôlevald et al. (2006).	24 months

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Treatment success Lasso di tempo: 24 months	Treatment success at 24 months will be assessed as a binary outcome. All participants will be clinically evaluated at 24 months, and each treated tooth will be classified as either successful or unsuccessful. Treatment will be considered successful when the treated tooth requires no operative reintervention during the 24-month follow-up period and remains asymptomatic, according to the clinical criteria described above. Natural exfoliation of the treated tooth during the follow-up period will also be considered a successful outcome. Treatment failure will be defined as the need for operative reintervention due to disease progression or treatment failure, including endodontic treatment or extraction.	24 months
Parents' and Child's Preference Lasso di tempo: Before randomization and prior to treatment	Before randomization, parents or guardians and the child will receive a standardized explanation of the two therapeutic approaches under investigation (replacement and repair of restorations). To aid comprehension, illustrative images generated by artificial intelligence will be presented, depicting each procedure in a standardized manner. Parents or guardians and the child will then be asked: "If you could choose, which treatment would you prefer?" Responses will be recorded as: replacement, repair, or no preference.	Before randomization and prior to treatment
Treatment Time Lasso di tempo: From the beginning to the completion of the treatment procedure	The total treatment time will be measured by a research assistant using a digital stopwatch. Timing will start at the beginning of the clinical intervention and stop immediately after its completion. Time will be recorded and expressed in minutes (min).	From the beginning to the completion of the treatment procedure
Child's Perception Lasso di tempo: Immediately after the procedure (Day 0)	The child's perception of the treatment will be assessed immediately after completion of the procedure using the Facial Image Scale (FIS). The scale will be presented by the research assistant, in the absence of the operator, in order to minimize the professional's influence on the response. The child will be asked to indicate the image that best represents how they felt during the treatment, following the question: "How did you feel during the treatment?" The FIS consists of five facial images ranging from a very happy to a very sad expression, allowing assessment of the child's acceptance of the experience.	Immediately after the procedure (Day 0)
Parents'/Guardians' Satisfaction Lasso di tempo: Immediately after the procedure (Day 0)	Immediately after completion of the treatment, parents or guardians will answer the following question: "How satisfied are you with the treatment performed on your child?" The response will be recorded on a five-point Likert scale, ranging from very dissatisfied to very satisfied.	Immediately after the procedure (Day 0)
Parents'/Guardians' Willingness to Choose the Treatment Again Lasso di tempo: 30 days after the procedure	At 30 days after the procedure, parents or guardians will be presented again with illustrative images of the two therapeutic approaches, accompanied by the same standardized explanation used in the initial assessment. They will then be asked: "If you could choose again, which treatment would you choose for your child?" Responses will be recorded as repair, replacement, or no preference.	30 days after the procedure
Cost-effectiveness Lasso di tempo: 24 months	Additionally, a cost-effectiveness analysis will be conducted comparing the repair and replacement of defective restorations in primary molars over 24 months of follow-up. Restoration survival over this period will be used as the effectiveness measure for the economic analysis. The analysis will adopt the perspective of the Brazilian public health system and will consider only direct treatment costs.	24 months
Treatment Cost Lasso di tempo: Immediately after the procedure (Day 0)	The direct costs associated with the repair and replacement of restorations will be compared, considering the clinical treatment time and materials actually used in each procedure. Treatment time will be measured by a research assistant who is not involved in performing the interventions and will be used to estimate the dental professional's labor cost based on the cost per hour of professional work. Material costs will be estimated based on the actual amount consumed during each procedure and the prices obtained from three quotations from different suppliers, with the mean value of the quotations used for cost calculation. Costs will be expressed in Brazilian reais (BRL), based on the prices prevailing during the study period.	Immediately after the procedure (Day 0)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Sao Paulo

Investigatori

Investigatore principale: Camila C Cabral, PhD, University of Sao Paulo

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

7 ottobre 2026

Completamento primario (Stimato)

1 aprile 2029

Completamento dello studio (Stimato)

1 aprile 2029

Date di iscrizione allo studio

Primo inviato

4 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 settembre 2026

Primo Inserito (Effettivo)

10 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

RepairPEDO

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Anonymized individual participant data (IPD) collected from parents and/or caregivers will be shared, including demographic and study-related data, treatment preference, treatment satisfaction, willingness to choose the treatment again, and other participant-level outcome data collected during the study. All data will be fully anonymized prior to sharing to prevent identification of participants or disclosure of sensitive information.

Periodo di condivisione IPD

Start date: After publication of the study results End date: No end date

Criteri di accesso alla condivisione IPD

Anonymized individual participant data and the study protocol will be publicly accessible to researchers and other interested users through the designated public data repository. Access will be unrestricted, subject to the repository's terms of use. Only fully anonymized data will be made available, with no information that could reasonably identify individual participants.

Tipo di informazioni di supporto alla condivisione IPD

STUDIO_PROTOCOLLO
LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Repair Versus Replacement of Failed Restorations in Primary Teeth