ReplacementREPCOMPNCT02043873
Can Repair Increase the Useful Life of Composite Resins?
An observational study of Replacement and Repair, run by University of Chile at 1 site in Chile.
Trial summary
Objectives: The aim of this prospective, randomized, triple-blind cohort study was to assess the longevity of repairs to localized clinical defects in composite restorations that were initially scheduled to be treated with a restoration replacement Methods: 28 patients aged 18 to 80 years with 50 composite… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Replacement, Repair, Composites Restorations
- How many people
- 28 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 28 patients aged 18 to 80 years (mean 26.5 years) of both females (58%) and males (42%) with 50 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile
Who may be able to join
- Patients with localized marginal deficiencies of composite restorations that were clinically judged to be suitable for repair, sealing, or refurbishing according to USPHS criteria (Table 1).
- 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 older than 18 years.
- Patients who agreed and signed the consent form for participating in the study.
- Area out of the restoration´s failure is in good condition.
Who cannot join
- Patients with contra-indications for regular dental treatment based on their medical history.
- Patients with special aesthetic requirements that could not be solved by repair treatments.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Repair Increase the Useful Life of Composite Resins? Clinical Trial: Triple-blind Controlled - 10 Year Follow-up
Objectives: The aim of this prospective, randomized, triple-blind cohort study was to assess the longevity of repairs to localized clinical defects in composite restorations that were initially scheduled to be treated with a restoration replacement Methods: 28 patients aged 18 to 80 years with 50 composite restorations were recruited.Restorations with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) were randomly assigned to the Repair (n = 25) or Replacement (n = 25) group, the quality of the restorations was scored according to the modified USPHS criteria. A Wilcoxon test was performed for comparisons between the same groups (CI=0.05). A Friedman test was utilized for multiple comparisons between different years of the same group.
Read the detailed description
A cohort of 28 patients aged 18 to 80 years of both females (58%) and males (42%) with 50 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. All participants presented with one or more clinical features that deviated from the ideal and were rated Bravo or Charlie according to the modified United States Public Health Service (USPHS) criteria 6. 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 a registration form. The selection criteria are summarized below.
2.2 Treatment Group Criteria Initially, 356 restorations (28 patients) were evaluated and assigned in accordance with the modified USPHS criteria, from which 50 were selected in accordance with the inclusion criteria. Restorations with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) were randomly assigned to the Repair (n = 25) or Replacement (n = 25) group (Figure 1). The randomization was performed by the Power Analysis and Sample Size System (PASS software v. 2008, Keysville, UT, USA), and diagnosis of active secondary caries was made based on Ekstrand criteria.
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 five parameters examined were marginal adaptation, anatomic form, surface roughness, secondary caries, and lustre. If a 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 Repair The clinicians (PV - GM) used carbide burs (330-010 Komet, Brasseler GmbH Co., Lemgo, Germany) to explore the defective margins of the restorations, beginning with the removal of part of the restorative material adjacent to the defect to act as an exploratory cavity; this allowed a proper diagnosis and evaluation of the extent of the defect. Provided that the defect was limited and localized, the clinician then removed any defective tooth tissue. Once this material was removed, an exploratory cavity preparation was done that included removal of any demineralized and soft tooth tissue. A self-priming resin bonding system was used (Adper Prompt L-Pop; 3M ESPE, St. Paul, MN, USA), followed by restoration with a resin-based composite (RBC) restorative material (Filtek Supreme; 3M ESPE). A rubber dam isolation was used for this procedure.
2.4.2 Replacement The clinicians totally removed and replaced the defective restorations. After completing the cavity preparations, it was restored with a new resin composite (RC; Filtek Supreme; 3M ESPE). The elimination of the soft tooth tissue caries infection was done using carbide burs at high speed under full water irrigation. During the cavity preparation, no preventive extension or undercutting areas were created, and all of the cavity angles were rounded. In the deep dentin, a glass-ionomer liner was used (Vitrebond; 3M ESPE; USA). Adper Prompt L-Pop, (3M ESPE) was used per the manufacturer instructions, and RBC (Filtek Supreme; 3M ESPE) was applied by the incremental technique. The occlusion was checked, and the restorations were finished and polished following the manufacturer instructions.
- Conditions
- Replacement, Repair, Composites Restorations
- Keywords
- Clinical Trial, Composite Restorations, Restorations Repair, Replacement Restorations, Operative Dentistry.
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 |
|---|---|---|
| 25 composite restorations replaced | 25 composite replaced with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) | |
| 25 composite repaired | 25 composite repaired with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality composites restorations
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 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 ReplacementStudies 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
- Retrospective
- Enrolment
- 28 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043873
- Sponsor's protocol ID
- FOUCH2012/10
- Acronym
- REPCOMP
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2014
- Last updated
- 23 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 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Repair Increase the Useful Life of Composite Resins? Clinical Trial: Triple-blind Controlled - 10 Year Follow-up
- ClinicalTrials.gov ID
- NCT02043873
- Acronym / sponsor ID
- REPCOMP / FOUCH2012/10
- Conditions
- Replacement, Repair, Composites Restorations
- Keywords
- Clinical Trial, Composite Restorations, Restorations Repair, Replacement Restorations, Operative Dentistry.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 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
- 23 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.
Objectives: The aim of this prospective, randomized, triple-blind cohort study was to assess the longevity of repairs to localized clinical defects in composite restorations that were initially scheduled to be treated with a restoration replacement Methods: 28 patients aged 18 to 80 years with 50 composite restorations were recruited.Restorations with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) were randomly assigned to the Repair (n = 25) or Replacement (n = 25) group, the quality of the restorations was scored according to the modified USPHS criteria. A Wilcoxon test was performed for comparisons between the same groups (CI=0.05). A Friedman test was utilized for multiple comparisons between different years of the same group.
Detailed description
A cohort of 28 patients aged 18 to 80 years of both females (58%) and males (42%) with 50 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. All participants presented with one or more clinical features that deviated from the ideal and were rated Bravo or Charlie according to the modified United States Public Health Service (USPHS) criteria 6. 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 a registration form. The selection criteria are summarized below.
2.2 Treatment Group Criteria Initially, 356 restorations (28 patients) were evaluated and assigned in accordance with the modified USPHS criteria, from which 50 were selected in accordance with the inclusion criteria. Restorations with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) were randomly assigned to the Repair (n = 25) or Replacement (n = 25) group (Figure 1). The randomization was performed by the Power Analysis and Sample Size System (PASS software v. 2008, Keysville, UT, USA), and diagnosis of active secondary caries was made based on Ekstrand criteria.
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 five parameters examined were marginal adaptation, anatomic form, surface roughness, secondary caries, and lustre. If a 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 Repair The clinicians (PV - GM) used carbide burs (330-010 Komet, Brasseler GmbH Co., Lemgo, Germany) to explore the defective margins of the restorations, beginning with the removal of part of the restorative material adjacent to the defect to act as an exploratory cavity; this allowed a proper diagnosis and evaluation of the extent of the defect. Provided that the defect was limited and localized, the clinician then removed any defective tooth tissue. Once this material was removed, an exploratory cavity preparation was done that included removal of any demineralized and soft tooth tissue. A self-priming resin bonding system was used (Adper Prompt L-Pop; 3M ESPE, St. Paul, MN, USA), followed by restoration with a resin-based composite (RBC) restorative material (Filtek Supreme; 3M ESPE). A rubber dam isolation was used for this procedure.
2.4.2 Replacement The clinicians totally removed and replaced the defective restorations. After completing the cavity preparations, it was restored with a new resin composite (RC; Filtek Supreme; 3M ESPE). The elimination of the soft tooth tissue caries infection was done using carbide burs at high speed under full water irrigation. During the cavity preparation, no preventive extension or undercutting areas were created, and all of the cavity angles were rounded. In the deep dentin, a glass-ionomer liner was used (Vitrebond; 3M ESPE; USA). Adper Prompt L-Pop, (3M ESPE) was used per the manufacturer instructions, and RBC (Filtek Supreme; 3M ESPE) was applied by the incremental technique. The occlusion was checked, and the restorations were finished and polished following the manufacturer instructions.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 composite restorations replaced | – | –25 composite replaced with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) |
| 25 composite repaired | – | –25 composite repaired with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 28 patients aged 18 to 80 years (mean 26.5 years) of both females (58%) and males (42%) with 50 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile
Key inclusion criteria (8 listed)
- Patients with localized marginal deficiencies of composite restorations that were clinically judged to be suitable for repair, sealing, or refurbishing according to USPHS criteria (Table 1).
- 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 special aesthetic requirements that could not be solved by repair treatments.
- 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.
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 composites restorations
Time frame: up to 10 years
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 23 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.
Related trials for Replacement
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
Active, not recruiting
At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Replacement and Repair, 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 8 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 23 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 composites restorations (time frame: up to 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 NCT02043873, 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 23 Jan 2014.