Dental CariesNCT05676671
Microbiological Evaluation and Clinical 24-month Follow-up of Adhesive Systems on Carious Dentin
A study testing Applications of self-etching adhesives and dental restorations in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The objectives were to evaluate the antibacterial effect of self-etching adhesives on carious dentin and the clinical results of restorations in a randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Applications of self-etching adhesives and dental restorations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- deciduous molars with one or two surfaces with caries lesions;
- children without systemic problems and who were not using any medication;
- absence of spontaneous pain, edema or fistula, and dental mobility;
- radiographically, caries lesions in the inner half of the dentin thickness, absence of pulp contact with the lesion, absence of internal or external root resorption, and other changes suggestive of degenerative pulp conditions, such as radiolucencies in the furcation or periapical regions or widening of periodontal spaces.
Who cannot join
- Caries lesions with involvement of the pulp or periodontal tissues;
- Children with systemic problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Self-etching Adhesive Systems on Caries-affected Dentin: Microbiological Evaluation and Clinical 24-month Follow-up
The objectives were to evaluate the antibacterial effect of self-etching adhesives on carious dentin and the clinical results of restorations in a randomized controlled clinical trial. 104 carious deciduous molars (n=92) were randomly allocated to receive one of the self-etching adhesives: Clearfil SE Bond - control (CB - n =53) or Clearfil SE Protect containing MDPB (CP - n=51) after caries removal selective. Clinical, radiographic, photographic and plaster model assessments (n=53 deciduous molars, CB=29, CP=24) of resin restorations were performed at baseline and at 6, 12, and 24 months. Dentin samples (n=51 deciduous teeth; CB=24 and CP=27) were collected immediately after excavation of carious dentin and 3 months later, and cultured for mutans streptococci - (MS), lactobacilli (LB) and total microorganisms (TM). Data were statistically analyzed (p<0.05).
Read the detailed description
One hundred and four teeth from 40 children aged 6 to 9 years with one or two superficial deciduous molar cavities (occlusal and/or proximal-occlusal cavities), presenting high caries activity, were selected for this study. Fifty-three primary molars were selected for clinical/ radiographical evaluation and 51 primary molars were selected for microbiological evaluation in two different moments.
Restorative treatments For this part of the study, 53 primary molars were randomly divided into Clearfil SE Bond (CB, n = 29) and Clearfil SE Protect (CP, n = 24). All restorative treatments were performed by the same examiner at the Graduate Dental Clinic of the Faculty of Dentistry of Piracicaba / State University of Campinas. A local anesthetic agent was used for all procedures. In the first consultation, the selected tooth was isolated with a rubber dam and dental prophylaxis performed with pumice paste. Next, 0.2% chlorhexidine gluconate was applied to the operative area. Class I/II cavities were prepared using a high-speed sterile carbide bur (#245, KG Sorensen, Barueri, São Paulo, Brazil) to remove frayed enamel, if necessary, and a size-compatible sterile round steel bur, in a low-speed handpiece, was used to clean decayed tissue (infected dentin) from the enamel-dentin junction and side walls of the cavity, leaving an affected dentin layer on the cavity floor to prevent pulp exposure. Soft and stainable carious dentin was detected using Caries Detector (Kuraray) and then one of the adhesive systems CB or CP was applied on the pulp floor. Following the manufacturer's instructions, the primer was quickly applied with a microbrush (KG Sorensen, Barueri, SP, Brazil) to enamel and dentin and left undisturbed for 20s (seconds). Next, the adhesive was applied to the entire cavity surface with a microbrush (KG Sorensen, Barueri, SP, Brazil). A gentle stream of oil-free air was applied, and light activation was performed for 10s with an Elipar Tri-light unit (3M ESPE, Seefeld 82229, Germany) with a power density of 800 mW/cm2. Teeth were restored with Filtek Z250 composite resin (3M ESPE, St Paul, MN, USA) in 2-3 mm increments and activated by light for 40s using the same light curing unit and power density. The occlusion was checked with carbon paper and adjusted. The restorations were completed with diamond burs (KG Sorensen, São Paulo, SP, Brazil) and Flex Discs (3M ESPE, St Paul, Minnesota, USA).
Direct clinical evaluation Each restoration was evaluated for color match, marginal fit, marginal discoloration, anatomical shape, and secondary caries using the USPHS criteria. The Alpha score indicates clinically optimal restoration, the Bravo score is a clinically acceptable situation, except for secondary caries, and the Charlie score indicates clinically unacceptable restorations that must be replaced. Before the evaluation, prophylaxis was performed with pumice and aqueous paste. All evaluations were carried out under normal clinical conditions with a dental surgical light, a mouth mirror, and a dental explorer. Evaluation of all restorations was carried out at 6, 12, and 24 months by two independent examiners who were blinded to the adhesive system group. If there was disagreement between the two examiners, a consensus was reached on the side of the chair.
Indirect clinical evaluation
- Photographic evaluation At each time-point, photos of the restorations were taken with a semi-professional digital camera (Sony Cyber-shot DSC-H7, Sony Brasil Ltda, São Paulo, São Paulo), for comparative evaluation of possible clinical changes that occurred during the experimental period. The assessment was performed using parameters similar to those of the clinical direct assessment: color combination, marginal discoloration, anatomical shape, and secondary caries, and excluding marginal integrity. Images with a 1.4X zoom were analyzed on the same computer by two examiners at different times. Individual scores were recorded for further analysis.
- Plaster models A polyvinyl siloxane impression (Elite HD + Putty Soft, Zhermack, Italy) was taken of each restored tooth and placed on special type IV plaster. The models were inspected by an examiner (AMS) using a stereomicroscope with 16x magnification. The selected sets did not present structural changes (positive or negative bubbles) or other deformations that could interfere with the assessment. The marginal integrity and anatomical structures of the restorations were assessed. The criteria were compared with the assessment recorded in the baseline model. The presence of wear was classified as a change in the initial anatomical shape, and fractures were considered as a change in the marginal integrity of the restorations.
Dentin collections and microbiological procedures For this second part of the study, 51 primary molars were randomly divided into Clearfil SE Bond (CB, n = 24) and Clearfil SE Protect (CP, n = 27). After cavity preparation and selective caries removal, as described above, the initial collection (baseline) of dentin affected by caries was performed with a sterile spoon excavator and transferred to a modified sterile instrument to standardize the amount of dentin (ca. 0.6 mg) removed from each tooth. The collected dentin was placed in tubes containing 1 mL sterile 0.9% NaCl solution for subsequent laboratory procedures. Subsequently, the pulp wall was completely covered with one of the adhesive systems, CB or CP. The cavities were provisionally restored with glass ionomer cement (Maxxion R, FGM, Joinville, SC, Brazil). After 3 months, the individuals returned, and their teeth were evaluated clinically and radiographically. After local anesthesia and isolation with a rubber dam, the provisional restoration was removed and the final collection (reentry) of the decayed dentin was carried out following the same procedures described in the initial collection. The teeth were definitively restored with Filtek Z 250 composite resin (3M ESPE, St Paul, MN, USA), maintaining the same adhesive system as used previously.
The dentin samples were ultrasonically dispersed for 15s (Ultrasonic, LC30, Germany) and diluted in decimal series in 0.9% NaCl. Subsequently, triplicate aliquots obtained from the dilutions were spread on Mitis Salivarius agar (Difco-BD, Sparks, MD, USA) supplemented with sucrose and bacitracin (0.2 U/mL) for isolation of mutans streptococci (MS), Rogosa Agar (Merck, Darmstadt, Germany) for lactobacilli (LB) and Brain Heart Infusion agar (Difco-BD, Sparks, MD, USA) with 5% defibrinated sheep blood to assess the total microorganism (TM). These plates were incubated for 24-48h at 37o C in an atmosphere of 5% of CO2. After incubation, the plates were photographed, and Image J software were used to count the total number of colony-forming units per milliliter (CFU/mL).
Criteria for clinical evaluation of the dentin substrate After removal of the infected dentin, the remaining carious dentin was evaluated according to the following criteria: dentin consistency: 0 = hard (similar to normal dentin), 1 = quite hard (dentin spoon removes tissue decayed when forced), and 2 = soft (tissue easily removed by the dentin spoon); dentin color: 0 = dark brown, 1 = light brown, and 2 = yellow; and dentin moisture: 0 = dry and 1 = wet.
- Conditions
- Dental Caries
- Being tested
- Applications of self-etching adhesives and dental restorations
- Keywords
- dental caries, primary tooth, dentin-bonding agents, streptococci, 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.
Applications of self-etching adhesives and dental restorationsProcedure or surgery
Also called Selective caries removal for microbiological evaluation
| Study group | Role | What they receive |
|---|---|---|
| Self-etching adhesive Clearfil SE Bond | Experimental | Group 1 received treatment with Clearfil SE Bond after selective caries removal Receives: Procedure: Applications of self-etching adhesives and dental restorations |
| Self-etching adhesiveClearfil SE Protect containing MDPB | Experimental | Group 2 received treatment with Clearfil SE Protect containing MDPB after selective caries removal Receives: Procedure: Applications of self-etching adhesives and dental restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of restorations using the USPHS criteria
Each restoration was evaluated for color match, marginal fit, marginal discoloration, anatomical shape, and secondary caries using the USPHS criteria. The Alpha score indicates clinically optimal restoration, the Bravo score is a clinically acceptable situation, except for secondary caries, and the Charlie score indicates clinically unacceptable restorations that must be replaced.
Measured: 6 years
Radiographic evaluation of restorations
Each restorarion was evaluated by periapical radiographs.
Measured: 6 years
Photographic evaluation of restorations
Photos of the restorations were taken with a semi-professional digital camera (Sony Cyber-shot DSC-H7, Sony Brasil Ltda, São Paulo, São Paulo), for comparative evaluation of possible clinical changes that occurred during the experimental period. The assessment was performed using parameters similar to those of the clinical direct assessment: color combination, marginal discoloration, anatomical shape, and secondary caries, and excluding marginal integrity.
Measured: 6 years
Evaluation of a plaster model of restorations
A polyvinyl siloxane impression (Elite HD + Putty Soft, Zhermack, Italy) was taken of each restored tooth and placed on special type IV plaster. The marginal integrity and anatomical structures of the restorations were assessed using the following criteria:
0- Anatomical form and margin with no alteration;
- Altered anatomical form and with no margin alteration;
- Anatomical form with no alterations and margin alteration;
- Altered anatomical form and margin alterations.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study startFeb 2010
- Primary completionApr 2012
- Study completionFeb 2020
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
- Model description
- 104 carious deciduous molars (n=92) were randomly allocated to receive one of the self-etching adhesives: Clearfil SE Bond - control (CB - n =53) or Clearfil SE Protect containing MDPB (CP - n=51) after caries removal selective
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiane Duque, University of Sao Paulo
- Investigators
- Cristiane Duque, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676671
- Sponsor's protocol ID
- 014/2008
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Self-etching Adhesive Systems on Caries-affected Dentin: Microbiological Evaluation and Clinical 24-month Follow-up
- ClinicalTrials.gov ID
- NCT05676671
- Acronym / sponsor ID
- 014/2008
- Conditions
- Dental Caries
- Keywords
- dental caries, primary tooth, dentin-bonding agents, streptococci, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 9 Jan 2023 (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.
The objectives were to evaluate the antibacterial effect of self-etching adhesives on carious dentin and the clinical results of restorations in a randomized controlled clinical trial. 104 carious deciduous molars (n=92) were randomly allocated to receive one of the self-etching adhesives: Clearfil SE Bond - control (CB - n =53) or Clearfil SE Protect containing MDPB (CP - n=51) after caries removal selective. Clinical, radiographic, photographic and plaster model assessments (n=53 deciduous molars, CB=29, CP=24) of resin restorations were performed at baseline and at 6, 12, and 24 months. Dentin samples (n=51 deciduous teeth; CB=24 and CP=27) were collected immediately after excavation of carious dentin and 3 months later, and cultured for mutans streptococci - (MS), lactobacilli (LB) and total microorganisms (TM). Data were statistically analyzed (p<0.05).
Detailed description
One hundred and four teeth from 40 children aged 6 to 9 years with one or two superficial deciduous molar cavities (occlusal and/or proximal-occlusal cavities), presenting high caries activity, were selected for this study. Fifty-three primary molars were selected for clinical/ radiographical evaluation and 51 primary molars were selected for microbiological evaluation in two different moments.
Restorative treatments For this part of the study, 53 primary molars were randomly divided into Clearfil SE Bond (CB, n = 29) and Clearfil SE Protect (CP, n = 24). All restorative treatments were performed by the same examiner at the Graduate Dental Clinic of the Faculty of Dentistry of Piracicaba / State University of Campinas. A local anesthetic agent was used for all procedures. In the first consultation, the selected tooth was isolated with a rubber dam and dental prophylaxis performed with pumice paste. Next, 0.2% chlorhexidine gluconate was applied to the operative area. Class I/II cavities were prepared using a high-speed sterile carbide bur (#245, KG Sorensen, Barueri, São Paulo, Brazil) to remove frayed enamel, if necessary, and a size-compatible sterile round steel bur, in a low-speed handpiece, was used to clean decayed tissue (infected dentin) from the enamel-dentin junction and side walls of the cavity, leaving an affected dentin layer on the cavity floor to prevent pulp exposure. Soft and stainable carious dentin was detected using Caries Detector (Kuraray) and then one of the adhesive systems CB or CP was applied on the pulp floor. Following the manufacturer's instructions, the primer was quickly applied with a microbrush (KG Sorensen, Barueri, SP, Brazil) to enamel and dentin and left undisturbed for 20s (seconds). Next, the adhesive was applied to the entire cavity surface with a microbrush (KG Sorensen, Barueri, SP, Brazil). A gentle stream of oil-free air was applied, and light activation was performed for 10s with an Elipar Tri-light unit (3M ESPE, Seefeld 82229, Germany) with a power density of 800 mW/cm2. Teeth were restored with Filtek Z250 composite resin (3M ESPE, St Paul, MN, USA) in 2-3 mm increments and activated by light for 40s using the same light curing unit and power density. The occlusion was checked with carbon paper and adjusted. The restorations were completed with diamond burs (KG Sorensen, São Paulo, SP, Brazil) and Flex Discs (3M ESPE, St Paul, Minnesota, USA).
Direct clinical evaluation Each restoration was evaluated for color match, marginal fit, marginal discoloration, anatomical shape, and secondary caries using the USPHS criteria. The Alpha score indicates clinically optimal restoration, the Bravo score is a clinically acceptable situation, except for secondary caries, and the Charlie score indicates clinically unacceptable restorations that must be replaced. Before the evaluation, prophylaxis was performed with pumice and aqueous paste. All evaluations were carried out under normal clinical conditions with a dental surgical light, a mouth mirror, and a dental explorer. Evaluation of all restorations was carried out at 6, 12, and 24 months by two independent examiners who were blinded to the adhesive system group. If there was disagreement between the two examiners, a consensus was reached on the side of the chair.
Indirect clinical evaluation
- Photographic evaluation At each time-point, photos of the restorations were taken with a semi-professional digital camera (Sony Cyber-shot DSC-H7, Sony Brasil Ltda, São Paulo, São Paulo), for comparative evaluation of possible clinical changes that occurred during the experimental period. The assessment was performed using parameters similar to those of the clinical direct assessment: color combination, marginal discoloration, anatomical shape, and secondary caries, and excluding marginal integrity. Images with a 1.4X zoom were analyzed on the same computer by two examiners at different times. Individual scores were recorded for further analysis.
- Plaster models A polyvinyl siloxane impression (Elite HD + Putty Soft, Zhermack, Italy) was taken of each restored tooth and placed on special type IV plaster. The models were inspected by an examiner (AMS) using a stereomicroscope with 16x magnification. The selected sets did not present structural changes (positive or negative bubbles) or other deformations that could interfere with the assessment. The marginal integrity and anatomical structures of the restorations were assessed. The criteria were compared with the assessment recorded in the baseline model. The presence of wear was classified as a change in the initial anatomical shape, and fractures were considered as a change in the marginal integrity of the restorations.
Dentin collections and microbiological procedures For this second part of the study, 51 primary molars were randomly divided into Clearfil SE Bond (CB, n = 24) and Clearfil SE Protect (CP, n = 27). After cavity preparation and selective caries removal, as described above, the initial collection (baseline) of dentin affected by caries was performed with a sterile spoon excavator and transferred to a modified sterile instrument to standardize the amount of dentin (ca. 0.6 mg) removed from each tooth. The collected dentin was placed in tubes containing 1 mL sterile 0.9% NaCl solution for subsequent laboratory procedures. Subsequently, the pulp wall was completely covered with one of the adhesive systems, CB or CP. The cavities were provisionally restored with glass ionomer cement (Maxxion R, FGM, Joinville, SC, Brazil). After 3 months, the individuals returned, and their teeth were evaluated clinically and radiographically. After local anesthesia and isolation with a rubber dam, the provisional restoration was removed and the final collection (reentry) of the decayed dentin was carried out following the same procedures described in the initial collection. The teeth were definitively restored with Filtek Z 250 composite resin (3M ESPE, St Paul, MN, USA), maintaining the same adhesive system as used previously.
The dentin samples were ultrasonically dispersed for 15s (Ultrasonic, LC30, Germany) and diluted in decimal series in 0.9% NaCl. Subsequently, triplicate aliquots obtained from the dilutions were spread on Mitis Salivarius agar (Difco-BD, Sparks, MD, USA) supplemented with sucrose and bacitracin (0.2 U/mL) for isolation of mutans streptococci (MS), Rogosa Agar (Merck, Darmstadt, Germany) for lactobacilli (LB) and Brain Heart Infusion agar (Difco-BD, Sparks, MD, USA) with 5% defibrinated sheep blood to assess the total microorganism (TM). These plates were incubated for 24-48h at 37o C in an atmosphere of 5% of CO2. After incubation, the plates were photographed, and Image J software were used to count the total number of colony-forming units per milliliter (CFU/mL).
Criteria for clinical evaluation of the dentin substrate After removal of the infected dentin, the remaining carious dentin was evaluated according to the following criteria: dentin consistency: 0 = hard (similar to normal dentin), 1 = quite hard (dentin spoon removes tissue decayed when forced), and 2 = soft (tissue easily removed by the dentin spoon); dentin color: 0 = dark brown, 1 = light brown, and 2 = yellow; and dentin moisture: 0 = dry and 1 = wet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 104 carious deciduous molars (n=92) were randomly allocated to receive one of the self-etching adhesives: Clearfil SE Bond - control (CB - n =53) or Clearfil SE Protect containing MDPB (CP - n=51) after caries removal selective
| Arm | Type | Receives |
|---|---|---|
| Self-etching adhesive Clearfil SE Bond | Experimental | Procedure: Applications of self-etching adhesives and dental restorationsGroup 1 received treatment with Clearfil SE Bond after selective caries removal |
| Self-etching adhesiveClearfil SE Protect containing MDPB | Experimental | Procedure: Applications of self-etching adhesives and dental restorationsGroup 2 received treatment with Clearfil SE Protect containing MDPB after selective caries removal |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- deciduous molars with one or two surfaces with caries lesions;
- children without systemic problems and who were not using any medication;
- absence of spontaneous pain, edema or fistula, and dental mobility;
- radiographically, caries lesions in the inner half of the dentin thickness, absence of pulp contact with the lesion, absence of internal or external root resorption, and other changes suggestive of degenerative pulp conditions, such as radiolucencies in the furcation or periapical regions or widening of periodontal spaces.
Key exclusion criteria (2 listed)
- Caries lesions with involvement of the pulp or periodontal tissues;
- Children with systemic problems.
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 |
|---|---|---|
| Applications of self-etching adhesives and dental restorationsAlso: Selective caries removal for microbiological evaluation | Procedure or surgery | Self-etching adhesive Clearfil SE Bond, Self-etching adhesiveClearfil SE Protect containing MDPB |
Primary outcome
Clinical evaluation of restorations using the USPHS criteria
Time frame: 6 years
Each restoration was evaluated for color match, marginal fit, marginal discoloration, anatomical shape, and secondary caries using the USPHS criteria. The Alpha score indicates clinically optimal restoration, the Bravo score is a clinically acceptable situation, except for secondary caries, and the Charlie score indicates clinically unacceptable restorations that must be replaced.
Radiographic evaluation of restorations
Time frame: 6 years
Each restorarion was evaluated by periapical radiographs.
Photographic evaluation of restorations
Time frame: 6 years
Photos of the restorations were taken with a semi-professional digital camera (Sony Cyber-shot DSC-H7, Sony Brasil Ltda, São Paulo, São Paulo), for comparative evaluation of possible clinical changes that occurred during the experimental period. The assessment was performed using parameters similar to those of the clinical direct assessment: color combination, marginal discoloration, anatomical shape, and secondary caries, and excluding marginal integrity.
Evaluation of a plaster model of restorations
Time frame: 6 years
A polyvinyl siloxane impression (Elite HD + Putty Soft, Zhermack, Italy) was taken of each restored tooth and placed on special type IV plaster. The marginal integrity and anatomical structures of the restorations were assessed using the following criteria: 0- Anatomical form and margin with no alteration; 1. Altered anatomical form and with no margin alteration; 2. Anatomical form with no alterations and margin alteration; 3. Altered anatomical form and margin alterations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
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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. This study is not recruiting at the moment.
Cristiane Duque, 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 Applications of self-etching adhesives and dental restorations in people with Dental Caries, 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of restorations using the USPHS criteria (time frame: 6 years). The study lists 4 primary outcomes in all. 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 9 Jan 2023.