Unsatisfactory or Defective Restoration of ToothREPAMLGNCT02051179
Longitudinal Results of a 10-Year Clinical Trial of Repair of Amalgam Restorations
An observational study of Unsatisfactory or Defective Restoration of Tooth, run by University of Chile at 1 site in Chile.
Trial summary
The aim of this prospective, randomized clinical trial was to assess the effectiveness of repair of localized clinical defects of amalgam restorations that were initially scheduled for replacement of restorations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unsatisfactory or Defective Restoration of Tooth
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- Aug 2003to Jan 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A cohort of 20 patients between the ages of 18 to 80 years old (mean 26.5 years), female (58%) and male (42%), with 40 (Class I and Class II) amalgam restorations, that presented one or more clinical features that deviated from the ideal (Bravo or Charlie according to modified United States Public Health Service USPHS criteria). All of them were recruited at the Operative Dentistry Clinic at the Dental School, University of Chile
Who may be able to join
- patients having at least one tooth with a localized marginal defective amalgam restoration(s) that was clinically determined to be suitable for repair, according to USPHS criteria
- patients with at least 20 teeth;
- restorations in functional occlusion with at least one opposing natural tooth;
- asymptomatic of post-operative sensitivity;
- with occlusal and proximal contact areas;
- patients older than 18 years; and
- patients who agreed and signed the informed consent form for participating in the study.
Who cannot join
- patients with contraindications for regular dental treatment based on their medical history
- patients who had special aesthetic needs that could not be solved by repair treatments
- patients with xerostomia and/or patients who were taking medication that significantly decreased salivary flow
- patients with high risk for caries
- patients with psychiatric or physical diseases, which interfered with oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective, randomized clinical trial was to assess the effectiveness of repair of localized clinical defects of amalgam restorations that were initially scheduled for replacement of restorations. A cohort of 20 patients with 40 (Class I and Class II) amalgam restorations, that presented one or more clinical features that deviated from the ideal (Bravo or Charlie) according to USPHS criteria, were randomly assigned to either, the repair or replacement group: A: repair n= 19 and B: replacement n=21. Two examiners who had calibration exercised evaluated the restorations at baseline and ten years after according to seven parameters: marginal occlusal adaptation, anatomic form, surface roughness, marginal staining, contact, secondary caries, and luster
Read the detailed description
Study Design A cohort of 20 patients between the ages of 18 to 80 years old (mean 26.5 years), female (58%) and male (42%), with 40 (Class I and Class II) amalgam restorations, that presented one or more clinical features that deviated from the ideal (Bravo or Charlie according to modified United States Public Health Service USPHS criteria). All of them were recruited at the Operative Dentistry Clinic at the Dental School, University of Chile. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile (project PRI-ODO-0207), and all patients signed an informed consent form and completed a registration form.
Treatment Group Criteria: 40 defective restorations were evaluated in accordance with the modified USPHS criteria. Restorations with clinically diagnosed secondary caries (Charlie) or under-contoured or over-contoured anatomic form defects and restorations with marginal defects (Bravo) were randomly assigned (Random Number Generator, Microsoft Excel 97) to either, the repair or replacement group. Diagnosis of active secondary caries was done according to Ekstrand's criteria 31.
The groups were labeled A: repair n= 19 (Class I n=8 and Class II n=11) and B: replacement n=21 (Class I n=9 and Class II n=12).
Restorations Assessment and Outcome Measurements. The quality of the restorations was scored according to the modified USPHS criteria (Table 1) 32. Two examiners underwent calibration exercises (JM and EF, Cohen's Kappa inter-examiner coefficient 0.74 at baseline and 0.87 at ten years). The examiners assessed the restorations independently by direct visual and tactile examination (mouth mirror, number 5, Hu Friedy Mfg. Co. Inc., Chicago, IL, USA, and explorer, number 23, Hu Friedy) and indirectly by radiographic examination (Bite Wing) at baseline (immediately after treatment) and 10 years after treatment. The seven examined parameters were marginal occlusal adaptation (MA), anatomic form (A), surface roughness (R), Marginal staining (MS), occlusal contact (O), secondary caries (SC), and luster (L) (Table 1). If any difference was recorded between the two examiners, and if they did not reach an agreement, a third clinician, who also underwent calibration exercises (GM), made the final decision.
Treatment Group
- Repair The clinicians (PV and CM) used Carbide burs (330-010 Komet, Brasseler GmbH Co. Postfach 160.32631, Lemgo, Germany) to explore the defective margin, carious lesion or anatomic form of the restorations. Part of the restorative material adjacent to the defect was removed as an exploratory proceedure thus allowing a proper evaluation and subsequent diagnosis of the extent of the defect. Provided that the defect was limited and localized, the clinician then removed any defective tooth tissue. Mechanical retention was employed inside the existing AM restoration. Rubber dam isolation was used for this procedure. Repair of the restorations was carried out with a dispersed-phased amalgam (Original D, Wyckle Research Inc, Carson City, NV, USA).
- Replacement The clinicians totally removed and replaced the defective restorations. After completing the cavity preparations, the tooth was restored with a new AM (Original D). Bonding agents and/or liners underneath the amalgam restorations were not used in this trial. Rubber dam isolation was used for all restorative treatments. .
Patients were recalled after four and ten years after the restoration were placed 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 their 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, SPSS15.0 (SPSS Inc, Chicago, IL) was used for statistical analysis.
- Keywords
- Repair, Replacement, Dental Amalgam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Replacement amalgam | Replacement The clinicians totally removed and replaced the defective restorations. After completing the cavity preparations, the tooth was restored with a new AM (Original D). Bonding agents and/or liners underneath the amalgam restorations were not used in this trial. Rubber dam isolation was used for all restorative treatments. . | |
| Repair Amalgam | The clinicians (PV and CM) used Carbide burs (330-010 Komet, Brasseler GmbH Co. Postfach 160.32631, Lemgo, Germany) to explore the defective margin, carious lesion or anatomic form of the restorations. Part of the restorative material adjacent to the defect was removed as an exploratory proceedure thus allowing a proper evaluation and subsequent diagnosis of the extent of the defect. Provided that the defect was limited and localized, the clinician then removed any defective tooth tissue. Mechanical retention was employed inside the existing AM restoration. Rubber dam isolation was used for this procedure. Repair of the restorations was carried out with a dispersed-phased amalgam (Original D, Wyckle Research Inc, Carson City, NV, USA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality amalgam restorations
20 healthy voluteers with amalgam restorations , assesment of quality of amalgams by USPHS criterial
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startAug 2003
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Unsatisfactory or Defective Restoration of ToothStudies 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
- 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 fernandez, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051179
- Sponsor's protocol ID
- FOUCH 2012/10/2
- Acronym
- REPAMLG
- Status last verified
- Jan 2014
- First submitted
- 25 Jan 2014
- Last updated
- 31 Jan 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 22788726Fernandez 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 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Results of a 10-Year Clinical Trial of Repair of Amalgam Restorations
- ClinicalTrials.gov ID
- NCT02051179
- Acronym / sponsor ID
- REPAMLG / FOUCH 2012/10/2
- Keywords
- Repair, Replacement, Dental Amalgam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Jan 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.
The aim of this prospective, randomized clinical trial was to assess the effectiveness of repair of localized clinical defects of amalgam restorations that were initially scheduled for replacement of restorations. A cohort of 20 patients with 40 (Class I and Class II) amalgam restorations, that presented one or more clinical features that deviated from the ideal (Bravo or Charlie) according to USPHS criteria, were randomly assigned to either, the repair or replacement group: A: repair n= 19 and B: replacement n=21. Two examiners who had calibration exercised evaluated the restorations at baseline and ten years after according to seven parameters: marginal occlusal adaptation, anatomic form, surface roughness, marginal staining, contact, secondary caries, and luster
Detailed description
Study Design A cohort of 20 patients between the ages of 18 to 80 years old (mean 26.5 years), female (58%) and male (42%), with 40 (Class I and Class II) amalgam restorations, that presented one or more clinical features that deviated from the ideal (Bravo or Charlie according to modified United States Public Health Service USPHS criteria). All of them were recruited at the Operative Dentistry Clinic at the Dental School, University of Chile. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile (project PRI-ODO-0207), and all patients signed an informed consent form and completed a registration form.
Treatment Group Criteria: 40 defective restorations were evaluated in accordance with the modified USPHS criteria. Restorations with clinically diagnosed secondary caries (Charlie) or under-contoured or over-contoured anatomic form defects and restorations with marginal defects (Bravo) were randomly assigned (Random Number Generator, Microsoft Excel 97) to either, the repair or replacement group. Diagnosis of active secondary caries was done according to Ekstrand's criteria 31.
The groups were labeled A: repair n= 19 (Class I n=8 and Class II n=11) and B: replacement n=21 (Class I n=9 and Class II n=12).
Restorations Assessment and Outcome Measurements. The quality of the restorations was scored according to the modified USPHS criteria (Table 1) 32. Two examiners underwent calibration exercises (JM and EF, Cohen's Kappa inter-examiner coefficient 0.74 at baseline and 0.87 at ten years). The examiners assessed the restorations independently by direct visual and tactile examination (mouth mirror, number 5, Hu Friedy Mfg. Co. Inc., Chicago, IL, USA, and explorer, number 23, Hu Friedy) and indirectly by radiographic examination (Bite Wing) at baseline (immediately after treatment) and 10 years after treatment. The seven examined parameters were marginal occlusal adaptation (MA), anatomic form (A), surface roughness (R), Marginal staining (MS), occlusal contact (O), secondary caries (SC), and luster (L) (Table 1). If any difference was recorded between the two examiners, and if they did not reach an agreement, a third clinician, who also underwent calibration exercises (GM), made the final decision.
Treatment Group
- Repair The clinicians (PV and CM) used Carbide burs (330-010 Komet, Brasseler GmbH Co. Postfach 160.32631, Lemgo, Germany) to explore the defective margin, carious lesion or anatomic form of the restorations. Part of the restorative material adjacent to the defect was removed as an exploratory proceedure thus allowing a proper evaluation and subsequent diagnosis of the extent of the defect. Provided that the defect was limited and localized, the clinician then removed any defective tooth tissue. Mechanical retention was employed inside the existing AM restoration. Rubber dam isolation was used for this procedure. Repair of the restorations was carried out with a dispersed-phased amalgam (Original D, Wyckle Research Inc, Carson City, NV, USA).
- Replacement The clinicians totally removed and replaced the defective restorations. After completing the cavity preparations, the tooth was restored with a new AM (Original D). Bonding agents and/or liners underneath the amalgam restorations were not used in this trial. Rubber dam isolation was used for all restorative treatments. .
Patients were recalled after four and ten years after the restoration were placed 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 their 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, SPSS15.0 (SPSS Inc, Chicago, IL) was used for statistical analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Replacement amalgam | – | –Replacement The clinicians totally removed and replaced the defective restorations. After completing the cavity preparations, the tooth was restored with a new AM (Original D). Bonding agents and/or liners underneath the amalgam restorations were not used in this trial. Rubber dam isolation was used for all restorative treatments. . |
| Repair Amalgam | – | –The clinicians (PV and CM) used Carbide burs (330-010 Komet, Brasseler GmbH Co. Postfach 160.32631, Lemgo, Germany) to explore the defective margin, carious lesion or anatomic form of the restorations. Part of the restorative material adjacent to the defect was removed as an exploratory proceedure thus allowing a proper evaluation and subsequent diagnosis of the extent of the defect. Provided that the defect was limited and localized, the clinician then removed any defective tooth tissue. Mechanical retention was employed inside the existing AM restoration. Rubber dam isolation was used for this procedure. Repair of the restorations was carried out with a dispersed-phased amalgam (Original D, Wyckle Research Inc, Carson City, NV, USA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 20 patients between the ages of 18 to 80 years old (mean 26.5 years), female (58%) and male (42%), with 40 (Class I and Class II) amalgam restorations, that presented one or more clinical features that deviated from the ideal (Bravo or Charlie according to modified United States Public Health Service USPHS criteria). All of them were recruited at the Operative Dentistry Clinic at the Dental School, University of Chile
Key inclusion criteria (7 listed)
- patients having at least one tooth with a localized marginal defective amalgam restoration(s) that was clinically determined to be suitable for repair, according to USPHS criteria
- patients with at least 20 teeth;
- restorations in functional occlusion with at least one opposing natural tooth;
- asymptomatic of post-operative sensitivity;
- with occlusal and proximal contact areas;
Key exclusion criteria (5 listed)
- patients with contraindications for regular dental treatment based on their medical history
- patients who had special aesthetic needs that could not be solved by repair treatments
- patients with xerostomia and/or patients who were taking medication that significantly decreased salivary flow
- patients with high risk for caries
- patients with psychiatric or physical diseases, which interfered with oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality amalgam restorations
Time frame: 10 years
20 healthy voluteers with amalgam restorations , assesment of quality of amalgams by USPHS criterial
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 31 Jan 2014.
- Results publication: 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.
- 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.
- 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 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 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 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.
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Unsatisfactory or Defective Restoration of Tooth
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 fernandez 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 Unsatisfactory or Defective Restoration of Tooth, 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 31 Jan 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?
Quality amalgam restorations (time frame: 10 years). 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 NCT02051179, which also lists 6 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 31 Jan 2014.