Dental CariesSEAL2NCT03214445
Sealing Defective Margins of Composite Restorations With Fluid Composite Resin Nanofiller Reinforced
A study testing Sealing margins with flow composite and Sealing margins with seal in people with Dental Caries and Minimally Invasive, run by University of Chile.
Trial summary
the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention , and then assessed by the FDI criteria for clinical performance and longevity of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Minimally Invasive, Repair
- What is being tested?
- Sealing margins with flow composite and Sealing margins with seal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 1 May 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- High risk of caries.
- With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria.
Who cannot join
- Patients with impossibility of mouth opening or dental treatments.
- Patients with allergies to any of the materials used.
- Presence of adjacent to the restoration or secondary caries.
- Patients with prior sealed of their restorations.
About this study
Official title: Reparación y Sellado de Restauraciones de Amalgama y Resinas Compuestas Para el Incremento de Su Longevidad Repair and Sealing of Amalgam and Composite Resins to Increase of Longevity
the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention , and then assessed by the FDI criteria for clinical performance and longevity of restorations
Read the detailed description
This is a prospective, double-blind randomized clinical trial under the recommendations of CONSORT. The statistical unit was considered the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention.
Inclusion criteria:
- Age 18 or older
- High risk of caries.
- With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria.
Exclusion criteria:
- Patients with the impossibility of mouth opening or dental treatments.
- Patients with allergies to any of the materials used.
- The presence of adjacent to the restoration or secondary caries.
- Patients with prior sealed of their restorations.
The volunteers were informed of the objectives and risks of treatment, as well as the freedom to leave the study. It explained in detail the clinical procedure which was submitted and proceeded to sign the informed consent according to the rules of the Ethics Committee of the Faculty of Dentistry of the University of Chile.
Then were assigned the sample within 3 groups of randomly with software Eclipse SDK 4.2.1: (1) sealing with fluid composite resin restorations with nano filled and universal adhesive, (2) sealant adhesive based on resin composite resin with universal adhesive and (3) group control or untreated.
Initial examination Examination of patients was performed independently by two calibrated evaluators, in case of disagreement operators were consulted with a third operator, this in a clinical field well lit, with the tooth surface clean with brush of prophylaxis and water, for the clinical examination was used to mirror No 5 (Hu-Friedy Mfg. Co. Inc., Chicago, IL, USA), probe of caries straight with active diameter of 150 μm portion (Deppeler, Swiss Dental) and caries probe straight with active portion of diameter 250 μm (Deppeler, Swiss Dental), both indicated by the FDI. For an optimal value in the parameter of marginal adaptation, the gap should be a size less than or equal to the diameter of the active portion of the probes.
Procedure
Once selected patients and their restorations, were polished using aluminum oxide disks with complete series (Sof-Lex. 3M ESPE) and polished tips (Diacomp, Brasseler).
Each restoration to seal received an identification code, which was awarded randomly belong to an experimental group, as described previously. The tabulation and data of each treatment were conducted in the program Microsoft Excel 2011.
Software Cariogram was used to assess the parameters for the analysis of risk cariogenic: the experience of caries, diseases related, content diet, the frequency of diet, the quantity of plaque, fluor exposition , salivary secretion, capacity buffer and clinical judgment.
Treatment and clinical intervention groups
Group 1::Sealed with fluid resin composite with nanofiller.
Once cleaned the restoration with prophylaxis hard brush and water, at low speed. The procedure was performed under absolute isolation with a rubber dam and using ejector to remove saliva and excess water. Following the protocol of conditionate surface with orthophosphoric acid 35%, for 15 seconds, washed ( abundant water by 30 s) and dried with compressed air from the syringe for 15 s. Then proceeded with the application of adhesive (Single Bond Universal, 3M ESPE) with brush (Microbrush International, Grafton, USA) and friction against the surface for 20 seconds, dried for 5 seconds for evaporation of the solvent remaining and photopolymerized for 10 seconds, using light curing (2500 Curing light, 3M ESPE).
Applied in marginal defects of nanoparticle flowable composite resin (Filtek Flow Z350XT, 3M ESPE) with instrument for cement application of calcium hydroxide (PICH, Hu Friedy Mfg. Co Inc., Chicago, IL, USA), it is polymerized for 20 seconds (2500 Curing light, 3 M ESPE).
The occlusal checked was controlled with paper articulate with 200 microns of width (Bausch Articulating Papers, Inc., USA), occlusal adjustments and wear were carried out with a stone No. 3 high speed (SSWhite, USA).
Group 2: Sealed with sealant based on resin. Once cleaned the restoration with prophylaxis hard brush and water, at low speed. The procedure was performed under absolute isolation with a rubber dam and using ejector to remove saliva and excess water. Following the same Protocol of conditioning, this was done with orthophosphoric acid 35%, for 15 seconds, wash by 30 seconds and dried with compressed air from the syringe for 15 seconds. Then proceeded with the application of adhesive (Single Bond Universal, 3M ESPE) with brush (Microbrush International, Grafton, USA) and friction against the surface for 20 seconds, flow of air for 5 seconds for evaporation of the solvent remaining and polymerizing for 10 seconds, using light curing (2500 Curing light, 3M ESPE).
Applied in marginal defects sealant of pits and fissures based on composite resin (Clinpro Sealant, 3 M ESPE) instrument of cement application of calcium hydroxide (PICH, Hu Friedy Mfg. Co Inc., Chicago, IL, USA), polymerized for 20 seconds (2500 Curing light, 3 M ESPE).
The occlusal checked was controlled with paper articulate 200 microns width (Bausch Articulating Papers, Inc., USA), occlusal adjustments and wear were carried out with stone No. 3 high speed (SSWhite, USA).
Group 3: control. The restorations were evaluated without treatment about defective restoration that was considered clinically acceptable.
Evaluation of treatments
Clinical assessments were made at 6 and 12 months in the parameters marginal adaptation, marginal staining and secondary caries and sealant retention.
Examination was performed independently by two calibrated operators, in case of disagreement were consulted with a third operator, this in a clinical field well lit, with the clean tooth surface with brush of prophylaxis and water, for the clinical examination was used the same methodology and instrumentation that examination.
Analysis of the clinical performance of the treatment groups
To evaluate the behavior of these treatments, after 6 and 12 months, was made the comparison versus baseline, whose valuation assigned to the subsequent application of seal evaluation was 1 (FDI), with the current state of the restoration.
- Conditions
- Dental Caries, Minimally Invasive, Repair
- Being tested
- Sealing margins with flow composite, Sealing margins with seal
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sealing margins with flow compositeProcedure or surgery
Seal the margin of restoration with Composite flow with nanofiller
Sealing margins with sealProcedure or surgery
Seal the margin of restoration with sealant without filler
| Study group | Role | What they receive |
|---|---|---|
| resin composite with nanofiller. | Experimental | 30 restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria randomized assigned in this group Receives: Procedure: Sealing margins with flow composite |
| sealant based on resin | Active comparator | 30 restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria randomized assigned in this group Receives: Procedure: Sealing margins with seal |
| Control | No intervention | The restorations were evaluated without treatment about defective restoration that was considered clinically acceptable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
( mm of bridge between tooth and restorations )
Measured: 6 month
Marginal staining,
( + >50% diameter / - <50% diameter)
Measured: 4 years
Retention of seal ( is present + / was loose -)
Loss of restoration
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Mar 2015
- Primary completion1 Dec 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- prospective, double blind randomized clinical trial under the recommendations of CONSORT. The statistical unit was considered the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Fernandez, University of Chile
- Investigators
- Javier Martin, Study director, U de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214445
- Sponsor's protocol ID
- 2012/10
- Acronym
- SEAL2
- Status last verified
- Jul 2017
- First submitted
- 18 May 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez E, Martin J, Vildosola P, Estay J, de Oliveira Junior OB, Gordan V, Mjor I, Gonzalez J, Loguercio AD, Moncada G. Sealing composite with defective margins, good care or over treatment? Results of a 10-year clinical trial. Oper Dent. 2015 Mar-Apr;40(2):144-52. doi: 10.2341/14-143-C. Epub 2014 Dec 23.
PubMed 25535778
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reparación y Sellado de Restauraciones de Amalgama y Resinas Compuestas Para el Incremento de Su Longevidad Repair and Sealing of Amalgam and Composite Resins to Increase of Longevity
- ClinicalTrials.gov ID
- NCT03214445
- Acronym / sponsor ID
- SEAL2 / 2012/10
- Conditions
- Dental Caries, Minimally Invasive, Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 11 Jul 2017 (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 patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention , and then assessed by the FDI criteria for clinical performance and longevity of restorations
Detailed description
This is a prospective, double-blind randomized clinical trial under the recommendations of CONSORT. The statistical unit was considered the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention.
Inclusion criteria:
- Age 18 or older
- High risk of caries.
- With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria.
Exclusion criteria:
- Patients with the impossibility of mouth opening or dental treatments.
- Patients with allergies to any of the materials used.
- The presence of adjacent to the restoration or secondary caries.
- Patients with prior sealed of their restorations.
The volunteers were informed of the objectives and risks of treatment, as well as the freedom to leave the study. It explained in detail the clinical procedure which was submitted and proceeded to sign the informed consent according to the rules of the Ethics Committee of the Faculty of Dentistry of the University of Chile.
Then were assigned the sample within 3 groups of randomly with software Eclipse SDK 4.2.1: (1) sealing with fluid composite resin restorations with nano filled and universal adhesive, (2) sealant adhesive based on resin composite resin with universal adhesive and (3) group control or untreated.
Initial examination Examination of patients was performed independently by two calibrated evaluators, in case of disagreement operators were consulted with a third operator, this in a clinical field well lit, with the tooth surface clean with brush of prophylaxis and water, for the clinical examination was used to mirror No 5 (Hu-Friedy Mfg. Co. Inc., Chicago, IL, USA), probe of caries straight with active diameter of 150 μm portion (Deppeler, Swiss Dental) and caries probe straight with active portion of diameter 250 μm (Deppeler, Swiss Dental), both indicated by the FDI. For an optimal value in the parameter of marginal adaptation, the gap should be a size less than or equal to the diameter of the active portion of the probes.
Procedure
Once selected patients and their restorations, were polished using aluminum oxide disks with complete series (Sof-Lex. 3M ESPE) and polished tips (Diacomp, Brasseler).
Each restoration to seal received an identification code, which was awarded randomly belong to an experimental group, as described previously. The tabulation and data of each treatment were conducted in the program Microsoft Excel 2011.
Software Cariogram was used to assess the parameters for the analysis of risk cariogenic: the experience of caries, diseases related, content diet, the frequency of diet, the quantity of plaque, fluor exposition , salivary secretion, capacity buffer and clinical judgment.
Treatment and clinical intervention groups
Group 1::Sealed with fluid resin composite with nanofiller.
Once cleaned the restoration with prophylaxis hard brush and water, at low speed. The procedure was performed under absolute isolation with a rubber dam and using ejector to remove saliva and excess water. Following the protocol of conditionate surface with orthophosphoric acid 35%, for 15 seconds, washed ( abundant water by 30 s) and dried with compressed air from the syringe for 15 s. Then proceeded with the application of adhesive (Single Bond Universal, 3M ESPE) with brush (Microbrush International, Grafton, USA) and friction against the surface for 20 seconds, dried for 5 seconds for evaporation of the solvent remaining and photopolymerized for 10 seconds, using light curing (2500 Curing light, 3M ESPE).
Applied in marginal defects of nanoparticle flowable composite resin (Filtek Flow Z350XT, 3M ESPE) with instrument for cement application of calcium hydroxide (PICH, Hu Friedy Mfg. Co Inc., Chicago, IL, USA), it is polymerized for 20 seconds (2500 Curing light, 3 M ESPE).
The occlusal checked was controlled with paper articulate with 200 microns of width (Bausch Articulating Papers, Inc., USA), occlusal adjustments and wear were carried out with a stone No. 3 high speed (SSWhite, USA).
Group 2: Sealed with sealant based on resin. Once cleaned the restoration with prophylaxis hard brush and water, at low speed. The procedure was performed under absolute isolation with a rubber dam and using ejector to remove saliva and excess water. Following the same Protocol of conditioning, this was done with orthophosphoric acid 35%, for 15 seconds, wash by 30 seconds and dried with compressed air from the syringe for 15 seconds. Then proceeded with the application of adhesive (Single Bond Universal, 3M ESPE) with brush (Microbrush International, Grafton, USA) and friction against the surface for 20 seconds, flow of air for 5 seconds for evaporation of the solvent remaining and polymerizing for 10 seconds, using light curing (2500 Curing light, 3M ESPE).
Applied in marginal defects sealant of pits and fissures based on composite resin (Clinpro Sealant, 3 M ESPE) instrument of cement application of calcium hydroxide (PICH, Hu Friedy Mfg. Co Inc., Chicago, IL, USA), polymerized for 20 seconds (2500 Curing light, 3 M ESPE).
The occlusal checked was controlled with paper articulate 200 microns width (Bausch Articulating Papers, Inc., USA), occlusal adjustments and wear were carried out with stone No. 3 high speed (SSWhite, USA).
Group 3: control. The restorations were evaluated without treatment about defective restoration that was considered clinically acceptable.
Evaluation of treatments
Clinical assessments were made at 6 and 12 months in the parameters marginal adaptation, marginal staining and secondary caries and sealant retention.
Examination was performed independently by two calibrated operators, in case of disagreement were consulted with a third operator, this in a clinical field well lit, with the clean tooth surface with brush of prophylaxis and water, for the clinical examination was used the same methodology and instrumentation that examination.
Analysis of the clinical performance of the treatment groups
To evaluate the behavior of these treatments, after 6 and 12 months, was made the comparison versus baseline, whose valuation assigned to the subsequent application of seal evaluation was 1 (FDI), with the current state of the restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- prospective, double blind randomized clinical trial under the recommendations of CONSORT. The statistical unit was considered the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention.
| Arm | Type | Receives |
|---|---|---|
| resin composite with nanofiller. | Experimental | Procedure: Sealing margins with flow composite30 restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria randomized assigned in this group |
| sealant based on resin | Active comparator | Procedure: Sealing margins with seal30 restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria randomized assigned in this group |
| Control | No intervention | –The restorations were evaluated without treatment about defective restoration that was considered clinically acceptable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- High risk of caries.
- With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria.
Key exclusion criteria (4 listed)
- Patients with impossibility of mouth opening or dental treatments.
- Patients with allergies to any of the materials used.
- Presence of adjacent to the restoration or secondary caries.
- Patients with prior sealed of their restorations.
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 |
|---|---|---|
| Sealing margins with flow compositeSeal the margin of restoration with Composite flow with nanofiller | Procedure or surgery | resin composite with nanofiller. |
| Sealing margins with sealSeal the margin of restoration with sealant without filler | Procedure or surgery | sealant based on resin |
Primary outcome
Marginal adaptation
Time frame: 6 month
( mm of bridge between tooth and restorations )
Marginal staining,
Time frame: 4 years
( + >50% diameter / - <50% diameter)
Retention of seal ( is present + / was loose -)
Time frame: 4 years
Loss of restoration
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 11 Jul 2017.
- Background: PubMed 25535778Fernandez E, Martin J, Vildosola P, Estay J, de Oliveira Junior OB, Gordan V, Mjor I, Gonzalez J, Loguercio AD, Moncada G. Sealing composite with defective margins, good care or over treatment? Results of a 10-year clinical trial. Oper Dent. 2015 Mar-Apr;40(2):144-52. doi: 10.2341/14-143-C. Epub 2014 Dec 23.
- Individual participant dataSharing planned: No
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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.
Javier Martin study director
U de Chile
Questions about this trial
What is this clinical trial studying?
A study testing Sealing margins with flow composite and Sealing margins with seal in people with Dental Caries and Minimally Invasive, run by University of Chile.
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 4 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Marginal adaptation (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03214445, which also lists 1 linked publication.
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 11 Jul 2017.