Dental Caries Secondary to Acquired Defects of Tooth StructureSealantNCT02075801
10-years Clinical Trial of Sealed of Margin Failures
An observational study of Dental Caries Secondary to Acquired Defects of Tooth Structure, run by University of Chile at 1 site in Chile.
Trial summary
Assess the effectiveness of sealing localized marginal defects of amalgam restorations that were initially scheduled for replacement of restorations. The hypothesis was that sealed defective margins of the amalgam restorations shows similar performance than replacement amalgam restorations. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Secondary to Acquired Defects of Tooth Structure
- What is being tested?
- Sealing of amalgam margin defects
- How many people
- 32 participants
- Where
- 1 siteChile
- Study dates
- Aug 2003to Feb 2014
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of the Operative Dentistry Clinics, School of Dentistry, University of Chile
Who may be able to join
- Patients with amalgam restorations with marginal deficiencies that were judged to be suitable for sealing.
- Older than 18 years of age ¨
- More than 20 teeth in their mouth
- The restorations had to be in functional occlusion with an opposing natural tooth
- With at least one proximal contact area with and adjacent tooth
- Area out of the restoration´s failures in good condition
- Patients who agree and sign the informed consent for participating in the study.
Who cannot join
- Patients with contraindications for regular dental treatment based on their medical history
- Special aesthetic requirements that could not be solved by this alternative treatment
- Xerostomia or who were taking medication that significantly decreased salivary flow
- High caries risk
- Psychiatric or physical diseases, that interfered with teeth hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Results of a 10-years Clinical Trial of Sealed Margin Failures of Amalgam Restorations
- Assess the effectiveness of sealing localized marginal defects of amalgam restorations that were initially scheduled for replacement of restorations.
- The hypothesis was that sealed defective margins of the amalgam restorations shows similar performance than replacement amalgam restorations.
Read the detailed description
Study Design
Were examined 157 patients with 586 amalgam restorations that were recruited at the Operative Dentistry Clinic, at the Dental School, University of Chile with the indication of amalgam replacements, of them, a cohort of thirty two patients (19 females and 13 males, mean age = 27 years old), with 73 Class I amalgam restorations, that presented one or more localized margin defects (Bravo or Charlie according to modified United State Public Health Service, USPHS criteria), were included in the study. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile, Investigation Project, School of Dentistry (0205) and all patients signed the informed consent form and completed the registration form. Only Faculty members were accepted to provide the treatment.
Treatment Groups Criteria: 73 restorations with defective margins were evaluated in accordance with the modified USPHS criteria and assigned to either the sealant (n=26), repair (n=21) and control groups (n=26).
Restorations Assessment: The quality of the restorations were evaluated using the modified U.S. Public Health System/Ryge criteria. Two examiners assessed the restorations independently and by visual and tactile (mouth mirror number 5) examination using an explorer (N° 23) and indirectly by radiographic, examination, for interproximal observation (Bite Wing). All the restorations were examined at baseline and each year during four and ten years after treatment. The restorations assessment was carried out by five parameters: marginal adaptation (MA), roughness (R), secondary caries (SC), marginal stain (MS) and teeth sensitivity (TS). If any difference was recorded between the 2 independent examiners, and they did not reach an agreement, a third clinician was called to assist with the process decision. If the three clinicians they did not reach an agreement, the lower score was recorded. All three clinicians participated in calibration exercises at the beginning and before the last examination took place and the inter-examiner reliability results were Kappa=0.74 at the baseline and Kappa=0.87 at the ten year.
A change from Bravo to Alpha was considered an improvement and a change from Alpha to Bravo was considered downgrade.
Caries risk assessment: A graphical computed program (CARIOGRAM) was used for individual´s patients caries risk assessed, the program weighted the interaction between the following 10 caries related factors: Caries experience, related general disease, diet contents, diet frequency, plaque amount by Silness Löe Index, semi quantitative detection of mutans streptococci and lactobacilli in saliva by Caries Risk Test (CRT), fluoride program, amount of saliva stimulated secretion by CRT Buffer (Vivadent), saliva buffer capacity and clinical judgment. Patients were classifying in high, intermediate and low caries risk. Additionally the results also indicate where targeted actions to improve the situation will have the best effect.
Patients were recalled ten years after the treatment, for clinical assessment by the same examiners, applying the same criteria used at baseline. Failed restorations were removed from the study and treated according to the diagnosed needs.
Statistical analysis The ordinal dependent variable was changed in level of the modified USPHS criteria from the baseline value. The assigned score of each restoration reflected the worst result for any of the parameters. The results of each group in terms of degradation or upgrade were analyzed by Friedman range non-parametric test to compare the pre and postoperative conditions. Additionally, the performance of all groups was contrasted using the Mann Whitney test to determine the differences between the upgrade and downgrade of the restoration´s quality. The statistical significance was set at 95%, α=0.05 and β=0.80 for statistical analysis.
- Being tested
- Sealing of amalgam margin defects
- Keywords
- Sealant, Margins Defect, Amalgam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sealing of amalgam margin defectsOther
Comparison between sealing of amalgam margins defects, replacement and non treated groups.
Sealing of amalgam margin defectsOther
Also called Use of Selant to seal amalgam margins defects
A.Sealing of amalgam margin defects: were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3MESPE) 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. All treatments were applied by the same clinician.
B.Replacement Group: The clinician totally removed and replaces the defective restoration with a new amalgam (Tytin, Kerr Corporation, Orange, CA, USA). Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician.
C.Control Group: The defective restorations did not receive any treatment.
| Study group | Role | What they receive |
|---|---|---|
| Defective amalgam restorations | Treatment Groups:
A. Sealing of amalgam margin defects: Defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Sealant, 3MESPE)was applied over the defective area. The sealant was polymerized with a photo curing unit (Curing-Light 2500, 3MESPE) for 40 seconds. Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician.
B. Replacement Group: The clinician totally removed and replaces the defective restoration with a new amalgam (Tytin, Kerr, Orange, USA). Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician.
C. Control Group: The defective restorations did not receive any treatment. Receives: Other: Sealing of amalgam margin defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Amalgam restorations quality according to United Stated Public Health Service (USPHS)
Restorations Assessment: The quality of the restorations were evaluated using the modified U.S. Public Health System criteria. Two examiners assessed the restorations independently and by visual and tactile examination. All the restorations were examined at baseline and ten years after treatment. The restorations assessment was carried out by five parameters: marginal adaptation, roughness, secondary caries, marginal stain and teeth sensitivity. All three clinicians participated in calibration exercises at the beginning and before the last examination took place and the inter-examiner reliability results were Kappa=0.74 at the baseline and Kappa=0.87 at the ten year.
Measured: Baseline and 10 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startAug 2003
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental Caries Secondary to Acquired Defects of Tooth StructureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Moncada, University of Chile
- Investigators
- Gustavo Moncada, DDS, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075801
- Sponsor's protocol ID
- PRI-ODO-0207
- Acronym
- Sealant
- Status last verified
- Feb 2014
- First submitted
- 21 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin J, Fernandez E, Estay J, Gordan VV, Mjor IA, Moncada G. Management of Class I and Class II Amalgam Restorations with Localized Defects: Five-Year Results. Int J Dent. 2013;2013:450260. doi: 10.1155/2013/450260. Epub 2013 Jan 28.
PubMed 23431302Martin 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 22788726Moncada G, Angel P, Fernandez E, Alonso P, Martin J, Gordan VV. Bond strength evaluation of nanohybrid resin-based composite repair. Gen Dent. 2012 May-Jun;60(3):230-4.
PubMed 22623463Fernandez 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 21537587Moncada 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 19339531Moncada 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 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 17004564
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Results of a 10-years Clinical Trial of Sealed Margin Failures of Amalgam Restorations
- ClinicalTrials.gov ID
- NCT02075801
- Acronym / sponsor ID
- Sealant / PRI-ODO-0207
- Keywords
- Sealant, Margins Defect, Amalgam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Mar 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.
- Assess the effectiveness of sealing localized marginal defects of amalgam restorations that were initially scheduled for replacement of restorations.
- The hypothesis was that sealed defective margins of the amalgam restorations shows similar performance than replacement amalgam restorations.
Detailed description
Study Design
Were examined 157 patients with 586 amalgam restorations that were recruited at the Operative Dentistry Clinic, at the Dental School, University of Chile with the indication of amalgam replacements, of them, a cohort of thirty two patients (19 females and 13 males, mean age = 27 years old), with 73 Class I amalgam restorations, that presented one or more localized margin defects (Bravo or Charlie according to modified United State Public Health Service, USPHS criteria), were included in the study. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile, Investigation Project, School of Dentistry (0205) and all patients signed the informed consent form and completed the registration form. Only Faculty members were accepted to provide the treatment.
Treatment Groups Criteria: 73 restorations with defective margins were evaluated in accordance with the modified USPHS criteria and assigned to either the sealant (n=26), repair (n=21) and control groups (n=26).
Restorations Assessment: The quality of the restorations were evaluated using the modified U.S. Public Health System/Ryge criteria. Two examiners assessed the restorations independently and by visual and tactile (mouth mirror number 5) examination using an explorer (N° 23) and indirectly by radiographic, examination, for interproximal observation (Bite Wing). All the restorations were examined at baseline and each year during four and ten years after treatment. The restorations assessment was carried out by five parameters: marginal adaptation (MA), roughness (R), secondary caries (SC), marginal stain (MS) and teeth sensitivity (TS). If any difference was recorded between the 2 independent examiners, and they did not reach an agreement, a third clinician was called to assist with the process decision. If the three clinicians they did not reach an agreement, the lower score was recorded. All three clinicians participated in calibration exercises at the beginning and before the last examination took place and the inter-examiner reliability results were Kappa=0.74 at the baseline and Kappa=0.87 at the ten year.
A change from Bravo to Alpha was considered an improvement and a change from Alpha to Bravo was considered downgrade.
Caries risk assessment: A graphical computed program (CARIOGRAM) was used for individual´s patients caries risk assessed, the program weighted the interaction between the following 10 caries related factors: Caries experience, related general disease, diet contents, diet frequency, plaque amount by Silness Löe Index, semi quantitative detection of mutans streptococci and lactobacilli in saliva by Caries Risk Test (CRT), fluoride program, amount of saliva stimulated secretion by CRT Buffer (Vivadent), saliva buffer capacity and clinical judgment. Patients were classifying in high, intermediate and low caries risk. Additionally the results also indicate where targeted actions to improve the situation will have the best effect.
Patients were recalled ten years after the treatment, for clinical assessment by the same examiners, applying the same criteria used at baseline. Failed restorations were removed from the study and treated according to the diagnosed needs.
Statistical analysis The ordinal dependent variable was changed in level of the modified USPHS criteria from the baseline value. The assigned score of each restoration reflected the worst result for any of the parameters. The results of each group in terms of degradation or upgrade were analyzed by Friedman range non-parametric test to compare the pre and postoperative conditions. Additionally, the performance of all groups was contrasted using the Mann Whitney test to determine the differences between the upgrade and downgrade of the restoration´s quality. The statistical significance was set at 95%, α=0.05 and β=0.80 for statistical analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Defective amalgam restorations | – | Other: Sealing of amalgam margin defectsTreatment Groups: A. Sealing of amalgam margin defects: Defective areas were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Sealant, 3MESPE)was applied over the defective area. The sealant was polymerized with a photo curing unit (Curing-Light 2500, 3MESPE) for 40 seconds. Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician. B. Replacement Group: The clinician totally removed and replaces the defective restoration with a new amalgam (Tytin, Kerr, Orange, USA). Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician. C. Control Group: The defective restorations did not receive any treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Operative Dentistry Clinics, School of Dentistry, University of Chile
Key inclusion criteria (7 listed)
- Patients with amalgam restorations with marginal deficiencies that were judged to be suitable for sealing.
- Older than 18 years of age ¨
- More than 20 teeth in their mouth
- The restorations had to be in functional occlusion with an opposing natural tooth
- With at least one proximal contact area with and adjacent tooth
Key exclusion criteria (5 listed)
- Patients with contraindications for regular dental treatment based on their medical history
- Special aesthetic requirements that could not be solved by this alternative treatment
- Xerostomia or who were taking medication that significantly decreased salivary flow
- High caries risk
- Psychiatric or physical diseases, that interfered with teeth hygiene.
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 of amalgam margin defectsComparison between sealing of amalgam margins defects, replacement and non treated groups. | Other | Defective amalgam restorations |
| Sealing of amalgam margin defectsAlso: Use of Selant to seal amalgam margins defectsA.Sealing of amalgam margin defects: were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3MESPE) 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. All treatments were applied by the same clinician. B.Replacement Group: The clinician totally removed and replaces the defective restoration with a new amalgam (Tytin, Kerr Corporation, Orange, CA, USA). Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician. C.Control Group: The defective restorations did not receive any treatment. | Other | Defective amalgam restorations |
Primary outcome
Changes of Amalgam restorations quality according to United Stated Public Health Service (USPHS)
Time frame: Baseline and 10 after treatment
Restorations Assessment: The quality of the restorations were evaluated using the modified U.S. Public Health System criteria. Two examiners assessed the restorations independently and by visual and tactile examination. All the restorations were examined at baseline and ten years after treatment. The restorations assessment was carried out by five parameters: marginal adaptation, roughness, secondary caries, marginal stain and teeth sensitivity. All three clinicians participated in calibration exercises at the beginning and before the last examination took place and the inter-examiner reliability results were Kappa=0.74 at the baseline and Kappa=0.87 at the ten year.
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 3 Mar 2014.
- Background: PubMed 23431302Martin J, Fernandez E, Estay J, Gordan VV, Mjor IA, Moncada G. Management of Class I and Class II Amalgam Restorations with Localized Defects: Five-Year Results. Int J Dent. 2013;2013:450260. doi: 10.1155/2013/450260. Epub 2013 Jan 28.
- Background: 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.
- Background: PubMed 22623463Moncada G, Angel P, Fernandez E, Alonso P, Martin J, Gordan VV. Bond strength evaluation of nanohybrid resin-based composite repair. Gen Dent. 2012 May-Jun;60(3):230-4.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
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.
Gustavo Moncada, DDS 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?
An observational study of Dental Caries Secondary to Acquired Defects of Tooth Structure, 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 7 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 3 Mar 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 of Amalgam restorations quality according to United Stated Public Health Service (USPHS) (time frame: Baseline and 10 after treatment). 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 NCT02075801, which also lists 7 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 3 Mar 2014.