Dental Restoration FailureSEALCOMPNCT02119195
Increasing Composite Restorations Sealants
A study testing Sealant in people with Dental Restoration Failure, run by University of Chile at 1 site in Chile.
Trial summary
A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%) and males (35%) with 80 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- Sealant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- May 2003to Dec 2013
- 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
- Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria.
- Patients with more than 20 teeth.
- Restorations in functional occlusions with an opposing natural tooth.
- Asymptomatic restored tooth.
- At least one proximal contact area with a neighbouring tooth.
- Patients are older than 18 years.
Show all 9Show fewer
- Patients who agreed and signed a consent form for participating in the study.
- Area out of the restoration´s failure is in good condition.
- Composite resins with alpha value in adaptation marginal criterial
Who cannot join
- Patients with contra-indications for regular dental treatment based on their medical history.
- Patients with xerostomia or taking medication that significantly decreased salivary flow.
- Patients with a high risk of caries.
- Patients with psychiatric or physical diseases, which interfered with oral hygiene.
- Patients with localized marginal deficiencies > 1 mm. and/or secondary caries adjacent to composite restorations , or major defects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Longevity of Composite Restorations With Defective Margins With Sealants. Controlled Clinical Trial 10 Years Follow-up
A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%) and males (35%) with 80 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. All participants presented with marginal adaptation clinical features that deviated from the ideal and were rated Bravo according to the modified United States Public Health Service (USPHS) criteria for the sealing group and no treatment group. As a positive control were considered composites with alpha values in marginal adaptation. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile (Project PRI-ODO-0207). All of the patients signed informed-consent forms and completed registration form. The selection criteria are summarized below.
Read the detailed description
Inclusion Criteria for Allocated groups :
Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria.
Patients with more than 20 teeth. Restorations in functional occlusions with an opposing natural tooth. Asymptomatic restored tooth. At least one proximal contact area with a neighbouring tooth. Patients are older than 18 years. Patients who agreed and signed a consent form for participating in the study. Area out of the restoration´s failure is in good condition.
Inclusion Criteria for Positive Control group :
Composite resins with alpha value in adaptation marginal criterial
Exclusion criteria:
Patients with contra-indications for regular dental treatment based on their medical history.
Patients with xerostomia or taking medication that significantly decreased salivary flow.
Patients with a high risk of caries. Patients with psychiatric or physical diseases, which interfered with oral hygiene.
Patients with localized marginal deficiencies > 1 mm. and/or secondary caries adjacent to composite restorations , or major defects 2.2 Treatment Group Criteria Initially, 356 restorations (28 patients) were evaluated and assigned in accordance with the modified USPHS criteria, from which 80 were selected in accordance with the inclusion criteria. Restorations with marginal defects (>0.5mm and <1mm) and/or marginal staining (Bravo) were randomly assigned to the Sealing (n = 20) or no treatment (n = 20) group. The randomization was performed by the Power Analysis and Sample Size System (Excel 2000,Microsoft,SEA, USA).
2.3 Restoration Assessment The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). The Cohen's Kappa inter-examiner coefficient was 0.74 at the baseline and 0.87 at ten years. Immediately after the treatment (baseline) and 10 years later, the examiners assessed the restorations independently by direct visual and tactile examination with mouth mirror number 5 and explorer number 23 (Hu Friedy Mfg. Co. Inc., Chicago, IL, USA) and indirectly by radiographic examination (bite wing). The four parameters examined were anatomic form, secondary caries, marginal staining and marginal adaptation. If the difference was recorded between the two examiners, and if they could not reach an agreement, a third clinician, who also underwent the calibration exercises (GM), made the final decision.
2.4 Treatment Groups 2.4.1 Sealing For this group, defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3M ESPE) was applied over the defective area. The sealant was polymerized with a photocuring unit (Curing Light 2500, 3M ESPE) for 40 seconds. Rubber dam isolation was used for this procedure.
2.4.2 No treatment The composite resin restorations had marginal defects, but were clinically acceptable, did not receive treatment.
2.4.3 Positive control Composite resins with alpha value in marginal adaptation criteria
- Conditions
- Dental Restoration Failure
- Being tested
- Sealant
- Keywords
- composite, sealant, longevity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SealantProcedure or surgery
Also called Clinpro Sealant, Alpha seal, Prime Dent
resin-based sealant (Clinpro Sealant, 3M ESPE)
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | The composite resin restorations had marginal defects, but were clinically acceptable, did not receive treatment |
| Positive control | No intervention | Composite resins with alpha value in marginal adaptation criteria |
| Intervention | Experimental | For this group, defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3M ESPE) was applied over the defective area. The sealant was polymerized with a photocuring unit (Curing Light 2500, 3M ESPE) for 40 seconds. Rubber dam isolation was used for this procedure Receives: Procedure: Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of restorations
The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). Immediately after the treatment (baseline) and 10 years later, the examiners assessed the restorations independently by direct visual and tactile examination with mouth mirror number 5 and explorer number 23 (Hu Friedy Mfg. Co. Inc., Chicago, IL, USA) and indirectly by radiographic examination (bite wing). The four parameters examined were anatomic form, secondary caries, marginal staining and marginal adaptation. If the difference was recorded between the two examiners, and if they could not reach an agreement, a third clinician, who also underwent the calibration exercises (GM), made the final decision.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2003
- Primary completionMay 2003
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental Restoration FailureStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 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
- Eduardo Fernández, Prof., Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119195
- Sponsor's protocol ID
- FOUCH2012/10-3
- Acronym
- SEALCOMP
- Status last verified
- Apr 2014
- First submitted
- 9 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moncada GC, Martin J, Fernandez E, Vildosola PG, Caamano C, Caro MJ, Mjor IA, Gordan VV. Alternative treatments for resin-based composite and amalgam restorations with marginal defects: a 12-month clinical trial. Gen Dent. 2006 Sep-Oct;54(5):314-8.
PubMed 17004564Moncada G, Fernandez E, Martin J, Arancibia C, Mjor IA, Gordan VV. Increasing the longevity of restorations by minimal intervention: a two-year clinical trial. Oper Dent. 2008 May-Jun;33(3):258-64. doi: 10.2341/07-113.
PubMed 18505215Moncada G, Martin J, Fernandez E, Hempel MC, Mjor IA, Gordan VV. Sealing, refurbishment and repair of Class I and Class II defective restorations: a three-year clinical trial. J Am Dent Assoc. 2009 Apr;140(4):425-32. doi: 10.14219/jada.archive.2009.0191.
PubMed 19339531Fernandez EM, Martin JA, Angel PA, Mjor IA, Gordan VV, Moncada GA. Survival rate of sealed, refurbished and repaired defective restorations: 4-year follow-up. Braz Dent J. 2011;22(2):134-9. doi: 10.1590/s0103-64402011000200008.
PubMed 21537587Martin J, Fernandez E, Estay J, Gordan VV, Mjor IA, Moncada G. Minimal invasive treatment for defective restorations: five-year results using sealants. Oper Dent. 2013 Mar-Apr;38(2):125-33. doi: 10.2341/12-062C. Epub 2012 Jul 11.
PubMed 22788726
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Longevity of Composite Restorations With Defective Margins With Sealants. Controlled Clinical Trial 10 Years Follow-up
- ClinicalTrials.gov ID
- NCT02119195
- Acronym / sponsor ID
- SEALCOMP / FOUCH2012/10-3
- Conditions
- Dental Restoration Failure
- Keywords
- composite, sealant, longevity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- May 2003 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Apr 2014 (estimated)
- 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.
A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%) and males (35%) with 80 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. All participants presented with marginal adaptation clinical features that deviated from the ideal and were rated Bravo according to the modified United States Public Health Service (USPHS) criteria for the sealing group and no treatment group. As a positive control were considered composites with alpha values in marginal adaptation. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile (Project PRI-ODO-0207). All of the patients signed informed-consent forms and completed registration form. The selection criteria are summarized below.
Detailed description
Inclusion Criteria for Allocated groups :
Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria.
Patients with more than 20 teeth. Restorations in functional occlusions with an opposing natural tooth. Asymptomatic restored tooth. At least one proximal contact area with a neighbouring tooth. Patients are older than 18 years. Patients who agreed and signed a consent form for participating in the study. Area out of the restoration´s failure is in good condition.
Inclusion Criteria for Positive Control group :
Composite resins with alpha value in adaptation marginal criterial
Exclusion criteria:
Patients with contra-indications for regular dental treatment based on their medical history.
Patients with xerostomia or taking medication that significantly decreased salivary flow.
Patients with a high risk of caries. Patients with psychiatric or physical diseases, which interfered with oral hygiene.
Patients with localized marginal deficiencies > 1 mm. and/or secondary caries adjacent to composite restorations , or major defects 2.2 Treatment Group Criteria Initially, 356 restorations (28 patients) were evaluated and assigned in accordance with the modified USPHS criteria, from which 80 were selected in accordance with the inclusion criteria. Restorations with marginal defects (>0.5mm and <1mm) and/or marginal staining (Bravo) were randomly assigned to the Sealing (n = 20) or no treatment (n = 20) group. The randomization was performed by the Power Analysis and Sample Size System (Excel 2000,Microsoft,SEA, USA).
2.3 Restoration Assessment The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). The Cohen's Kappa inter-examiner coefficient was 0.74 at the baseline and 0.87 at ten years. Immediately after the treatment (baseline) and 10 years later, the examiners assessed the restorations independently by direct visual and tactile examination with mouth mirror number 5 and explorer number 23 (Hu Friedy Mfg. Co. Inc., Chicago, IL, USA) and indirectly by radiographic examination (bite wing). The four parameters examined were anatomic form, secondary caries, marginal staining and marginal adaptation. If the difference was recorded between the two examiners, and if they could not reach an agreement, a third clinician, who also underwent the calibration exercises (GM), made the final decision.
2.4 Treatment Groups 2.4.1 Sealing For this group, defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3M ESPE) was applied over the defective area. The sealant was polymerized with a photocuring unit (Curing Light 2500, 3M ESPE) for 40 seconds. Rubber dam isolation was used for this procedure.
2.4.2 No treatment The composite resin restorations had marginal defects, but were clinically acceptable, did not receive treatment.
2.4.3 Positive control Composite resins with alpha value in marginal adaptation criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | –The composite resin restorations had marginal defects, but were clinically acceptable, did not receive treatment |
| Positive control | No intervention | –Composite resins with alpha value in marginal adaptation criteria |
| Intervention | Experimental | Procedure: SealantFor this group, defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3M ESPE) was applied over the defective area. The sealant was polymerized with a photocuring unit (Curing Light 2500, 3M ESPE) for 40 seconds. Rubber dam isolation was used for this procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria.
- Patients with more than 20 teeth.
- Restorations in functional occlusions with an opposing natural tooth.
- Asymptomatic restored tooth.
- At least one proximal contact area with a neighbouring tooth.
Key exclusion criteria (5 listed)
- Patients with contra-indications for regular dental treatment based on their medical history.
- Patients with xerostomia or taking medication that significantly decreased salivary flow.
- Patients with a high risk of caries.
- Patients with psychiatric or physical diseases, which interfered with oral hygiene.
- Patients with localized marginal deficiencies > 1 mm. and/or secondary caries adjacent to composite restorations , or major defects
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 |
|---|---|---|
| SealantAlso: Clinpro Sealant, Alpha seal, Prime Dentresin-based sealant (Clinpro Sealant, 3M ESPE) | Procedure or surgery | Intervention |
Primary outcome
Changes in quality of restorations
Time frame: 1 year
The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). Immediately after the treatment (baseline) and 10 years later, the examiners assessed the restorations independently by direct visual and tactile examination with mouth mirror number 5 and explorer number 23 (Hu Friedy Mfg. Co. Inc., Chicago, IL, USA) and indirectly by radiographic examination (bite wing). The four parameters examined were anatomic form, secondary caries, marginal staining and marginal adaptation. If the difference was recorded between the two examiners, and if they could not reach an agreement, a third clinician, who also underwent the calibration exercises (GM), made the final decision.
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 21 Apr 2014.
- Results publication: PubMed 17004564Moncada GC, Martin J, Fernandez E, Vildosola PG, Caamano C, Caro MJ, Mjor IA, Gordan VV. Alternative treatments for resin-based composite and amalgam restorations with marginal defects: a 12-month clinical trial. Gen Dent. 2006 Sep-Oct;54(5):314-8.
- Results publication: PubMed 18505215Moncada G, Fernandez E, Martin J, Arancibia C, Mjor IA, Gordan VV. Increasing the longevity of restorations by minimal intervention: a two-year clinical trial. Oper Dent. 2008 May-Jun;33(3):258-64. doi: 10.2341/07-113.
- Results publication: PubMed 19339531Moncada G, Martin J, Fernandez E, Hempel MC, Mjor IA, Gordan VV. Sealing, refurbishment and repair of Class I and Class II defective restorations: a three-year clinical trial. J Am Dent Assoc. 2009 Apr;140(4):425-32. doi: 10.14219/jada.archive.2009.0191.
- Results publication: PubMed 21537587Fernandez EM, Martin JA, Angel PA, Mjor IA, Gordan VV, Moncada GA. Survival rate of sealed, refurbished and repaired defective restorations: 4-year follow-up. Braz Dent J. 2011;22(2):134-9. doi: 10.1590/s0103-64402011000200008.
- Results publication: PubMed 22788726Martin J, Fernandez E, Estay J, Gordan VV, Mjor IA, Moncada G. Minimal invasive treatment for defective restorations: five-year results using sealants. Oper Dent. 2013 Mar-Apr;38(2):125-33. doi: 10.2341/12-062C. Epub 2012 Jul 11.
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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.
Eduardo Fernández, Prof. principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sealant in people with Dental Restoration Failure, run by University of Chile at 1 site in 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 9 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: finished, as of the sponsor's last update on 21 Apr 2014. 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 Chile. 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?
Changes in quality of restorations (time frame: 1 year). 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 NCT02119195, which also lists 5 linked publications.
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 Apr 2014.