Dental CariesNCT07813065
Repair Versus Replacement of Failed Restorations in Primary Teeth
A study testing Repair of Failed Restoration and Replacement of Failed Restoration in people with Dental Caries and Restoration Defects, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Dental Caries, Restoration Defects, Primary Teeth
- What is being tested?
- Repair of Failed Restoration and Replacement of Failed Restoration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Oct 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
University of São Paulo, School of Dentistry
São Paulo, São Paulo, 05508-000
Tamara K Tedesco, PhD, +5511954866622, tamarakt@usp.br
Camila C Cabral, PhD, +5511996254588, camila.cabral@usp.br
About this study
Official title: 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%).
- Conditions
- Dental Caries, Restoration Defects, Primary Teeth
- Being tested
- Repair of Failed Restoration, Replacement of Failed Restoration
- Keywords
- Tooth, Deciduous, Dental Restoration Failure, Dental Restoration, Permanent, Glass Ionomer Cements;, Child, Randomized Controlled Trial;
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of Failed RestorationProcedure or surgery
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.
Replacement of Failed RestorationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Repair | Experimental | Repair of Failed restoration in primary teeth. Receives: Procedure: Repair of Failed Restoration |
| Replacement | Active comparator | Replacement of Failed Restoration in primary teeth. Receives: Procedure: Replacement of Failed Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration survival rate
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).
Measured: 24 months
Secondary outcomes (8)
Treatment success rate
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.
Measured: 24 months
Parents' and Child's Preference
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.
Measured: Before randomization and prior to treatment
Treatment Time
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).
Measured: From the beginning to the completion of the treatment procedure
Child's perception of treatment measured by the Facial Image Scale
The child's perception of the treatment will be assessed immediately after completion of the procedure using the Facial Image Scale (FIS). The scale consists of five facial images scored from 1 to 5, ranging from a very happy expression (score 1) to a very sad expression (score 5). Higher scores indicate a more negative perception of the treatment, whereas lower scores indicate a more positive perception.
The scale will be presented by a research assistant, in the absence of the operator, in order to minimize the professional's influence on the child's 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?"
Measured: Immediately after the procedure (Day 0)
Parents'/Guardians' satisfaction with the treatment using five-point Likert scale
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 using a five-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction with the treatment, whereas lower scores indicate lower satisfaction.
Measured: Immediately after the procedure (Day 0)
Parents'/Guardians' Willingness to Choose the Treatment Again
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.
Measured: 30 days after the procedure
Incremental cost-effectiveness ratio (ICER) of restoration repair versus replacement
A cost-effectiveness analysis will be conducted comparing the repair and replacement of defective restorations in primary molars over 24 months of follow-up. Costs will be measured as direct treatment costs in Brazilian reais (BRL), and effectiveness will be measured as restoration survival over 24 months. The incremental cost-effectiveness ratio (ICER) will be calculated as the difference in mean costs between the repair and replacement groups divided by the difference in mean effectiveness between the groups. The ICER will therefore represent the additional cost per additional surviving restoration associated with one treatment strategy compared with the other.
The analysis will adopt the perspective of the Brazilian public health system and will consider only direct treatment costs..
Measured: 24 months
Mean direct treatment cost per restoration in Brazilian reais (BRL)
The direct costs associated with the repair and replacement of restorations will be calculated and 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. The total direct treatment cost for each restoration will be calculated by summing the labor and material costs and will be expressed in Brazilian reais (BRL), based on the prices prevailing during the study period. The mean direct treatment cost per restoration will be reported for each treatment group.
Measured: Immediately after the procedure (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start7 Oct 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Kerber Tedesco, University of Sao Paulo
- Investigators
- Camila C Cabral, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813065
- Sponsor's protocol ID
- RepairPEDO
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair Versus Replacement of Failed Restorations in Primary Teeth: Protocol for a Non-Inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07813065
- Acronym / sponsor ID
- RepairPEDO
- Conditions
- Dental Caries, Restoration Defects, Primary Teeth
- Keywords
- Tooth, Deciduous, Dental Restoration Failure, Dental Restoration, Permanent, Glass Ionomer Cements;, Child, Randomized Controlled Trial;
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 7 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repair | Experimental | Procedure: Repair of Failed RestorationRepair of Failed restoration in primary teeth. |
| Replacement | Active comparator | Procedure: Replacement of Failed RestorationReplacement of Failed Restoration in primary teeth. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair of Failed RestorationPrior 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. | Procedure or surgery | Repair |
| Replacement of Failed RestorationPrior 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 | Procedure or surgery | Replacement |
Primary outcome
Restoration survival rate
Time frame: 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).
8 secondary outcomes
Treatment success rate
Time frame: 24 months
Parents' and Child's Preference
Time frame: Before randomization and prior to treatment
Treatment Time
Time frame: From the beginning to the completion of the treatment procedure
Child's perception of treatment measured by the Facial Image Scale
Time frame: Immediately after the procedure (Day 0)
Parents'/Guardians' satisfaction with the treatment using five-point Likert scale
Time frame: Immediately after the procedure (Day 0)
Parents'/Guardians' Willingness to Choose the Treatment Again
Time frame: 30 days after the procedure
Incremental cost-effectiveness ratio (ICER) of restoration repair versus replacement
Time frame: 24 months
Mean direct treatment cost per restoration in Brazilian reais (BRL)
Time frame: Immediately after the procedure (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camila C Cabral, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair of Failed Restoration and Replacement of Failed Restoration in people with Dental Caries and Restoration Defects, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamara K Tedesco, PhD (+5511954866622, tamarakt@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration survival rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.