Dental Caries Class IINCT04827823
Retrospective Evaluation of Posterior Direct Restorations
An observational study of Dental Caries Class II, run by Western University, Canada at 1 site in Canada.
Trial summary
This retrospective study aims to evaluate the clinical performance of posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a five-year period. Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Class II
- What is being tested?
- Retrospective evaluation of amalgam and composite restorations
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 10 May 2017to 15 Dec 2017
- 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 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults patients who had complex amalgam or resin composite restorations (three or more surfaces) placed on molar or premolar areas by dental students in the Adult Dental Clinic over a five-year period.
Who may be able to join
- Presence of multi-surface (three or more surfaces) composite or amalgam restorations placed by dental students over a five-year period.
Who cannot join
- Children
- Restorations performed before or after five years on the time of evaluation
- Restorations with fewer than 3 surfaces
Trial locations and contacts
1 site in 1 country.
Canada1 site
Schulich Medicine and Dentistry - Western University
London, Ontario, N6A5C1
About this study
Official title: Five-year Retrospective Clinical Evaluation of Multi-surface Amalgam and Resin Composite Restorations Placed by Dental Students
This retrospective study aims to evaluate the clinical performance of posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a five-year period.
Read the detailed description
Purpose: The aim of this retrospective study is to evaluate the clinical performance of posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a five-year period. Materials and Methods: A total of 119 multi-surface Class II restorations (three or more surfaces) placed by third and fourth year students will be evaluated (AM: n = 69 and RC: n = 50). Restorations were assessed clinically according to the USPHS criteria by two independent evaluators using mirrors and probes. Data will be analyzed using Chisquare, Mann-Whitney and Wilcoxon tests at a 0.05 level of significance.
- Conditions
- Dental Caries Class II
- Being tested
- Retrospective evaluation of amalgam and composite restorations
- Keywords
- Amalgam, Dental, Composite Resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective evaluation of amalgam and composite restorationsOther
Multi-surface restorations that were performed by dental students and that are in function for the last five years will be clinically evaluated with mirrors and probes according to the modified USPHS criteria.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Amalgam restorations | Multi-surface amalgam restorations performed by dental students and are in function for about 5 years. Receives: Other: Retrospective evaluation of amalgam and composite restorations | |
| Group 2- Composite restorations | Multi-surface composite restorations performed by dental students and are in function for about 5 years. Receives: Other: Retrospective evaluation of amalgam and composite restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sensitivity
No Patient-reported sensitivity to hot and cold stimuli, sweets, clenching, and chewing related to the restoration (Alpha)
Measured: 5 years
Secondary caries
No visual evidence of dark, deep discoloration adjacent to the restoration (Alpha)
Measured: 5 years
Proximal contact
No open contact. Contact offers resistance to the dental floss (Alpha)
Measured: 5 years
Marginal Adaptation
Restoration closely adapted to the tooth. No crevice visible (Alpha)
Measured: 5 years
Fracture restoration
No evidence of fracture (Alpha)
Measured: 5 years
Fracture tooth
No evidence of fracture (Alpha)
Measured: 5 years
Anatomy
Restorations continuous with existing anatomic form (Alpha)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start10 May 2017
- Primary completion22 Sep 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental Caries Class IIStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827823
- Sponsor's protocol ID
- 109006
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cetin AR, Unlu N, Cobanoglu N. A five-year clinical evaluation of direct nanofilled and indirect composite resin restorations in posterior teeth. Oper Dent. 2013 Mar-Apr;38(2):E1-11. doi: 10.2341/12-160-C. Epub 2012 Dec 5.
PubMed 23215545Mjor IA, Jokstad A. Five-year study of Class II restorations in permanent teeth using amalgam, glass polyalkenoate (ionomer) cerment and resin-based composite materials. J Dent. 1993 Dec;21(6):338-43. doi: 10.1016/0300-5712(93)90006-c.
PubMed 8258583Vidnes-Kopperud S, Tveit AB, Gaarden T, Sandvik L, Espelid I. Factors influencing dentists' choice of amalgam and tooth-colored restorative materials for Class II preparations in younger patients. Acta Odontol Scand. 2009;67(2):74-9. doi: 10.1080/00016350802577800.
PubMed 19085213Correa MB, Peres MA, Peres KG, Horta BL, Barros AD, Demarco FF. Amalgam or composite resin? Factors influencing the choice of restorative material. J Dent. 2012 Sep;40(9):703-10. doi: 10.1016/j.jdent.2012.04.020. Epub 2012 Apr 28.
PubMed 22546263Rasines Alcaraz MG, Veitz-Keenan A, Sahrmann P, Schmidlin PR, Davis D, Iheozor-Ejiofor Z. Direct composite resin fillings versus amalgam fillings for permanent or adult posterior teeth. Cochrane Database Syst Rev. 2014 Mar 31;(3):CD005620. doi: 10.1002/14651858.CD005620.pub2.
PubMed 24683067Rho YJ, Namgung C, Jin BH, Lim BS, Cho BH. Longevity of direct restorations in stress-bearing posterior cavities: a retrospective study. Oper Dent. 2013 Nov-Dec;38(6):572-82. doi: 10.2341/12-432-C. Epub 2013 Apr 3.
PubMed 23550914Beck F, Lettner S, Graf A, Bitriol B, Dumitrescu N, Bauer P, Moritz A, Schedle A. Survival of direct resin restorations in posterior teeth within a 19-year period (1996-2015): A meta-analysis of prospective studies. Dent Mater. 2015 Aug;31(8):958-85. doi: 10.1016/j.dental.2015.05.004. Epub 2015 Jun 16.
PubMed 26091581Borgia E, Baron R, Borgia JL. Quality and Survival of Direct Light-Activated Composite Resin Restorations in Posterior Teeth: A 5- to 20-Year Retrospective Longitudinal Study. J Prosthodont. 2019 Jan;28(1):e195-e203. doi: 10.1111/jopr.12630. Epub 2017 May 17.
PubMed 28513897
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-year Retrospective Clinical Evaluation of Multi-surface Amalgam and Resin Composite Restorations Placed by Dental Students
- ClinicalTrials.gov ID
- NCT04827823
- Acronym / sponsor ID
- 109006
- Conditions
- Dental Caries Class II
- Keywords
- Amalgam, Dental, Composite Resin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 22 Sep 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study aims to evaluate the clinical performance of posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a five-year period.
Detailed description
Purpose: The aim of this retrospective study is to evaluate the clinical performance of posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a five-year period. Materials and Methods: A total of 119 multi-surface Class II restorations (three or more surfaces) placed by third and fourth year students will be evaluated (AM: n = 69 and RC: n = 50). Restorations were assessed clinically according to the USPHS criteria by two independent evaluators using mirrors and probes. Data will be analyzed using Chisquare, Mann-Whitney and Wilcoxon tests at a 0.05 level of significance.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- Amalgam restorations | – | Other: Retrospective evaluation of amalgam and composite restorationsMulti-surface amalgam restorations performed by dental students and are in function for about 5 years. |
| Group 2- Composite restorations | – | Other: Retrospective evaluation of amalgam and composite restorationsMulti-surface composite restorations performed by dental students and are in function for about 5 years. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients who had complex amalgam or resin composite restorations (three or more surfaces) placed on molar or premolar areas by dental students in the Adult Dental Clinic over a five-year period.
Key inclusion criteria (1 listed)
- Presence of multi-surface (three or more surfaces) composite or amalgam restorations placed by dental students over a five-year period.
Key exclusion criteria (3 listed)
- Children
- Restorations performed before or after five years on the time of evaluation
- Restorations with fewer than 3 surfaces
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 |
|---|---|---|
| Retrospective evaluation of amalgam and composite restorationsMulti-surface restorations that were performed by dental students and that are in function for the last five years will be clinically evaluated with mirrors and probes according to the modified USPHS criteria. | Other | Group 1- Amalgam restorations, Group 2- Composite restorations |
Primary outcome
Postoperative sensitivity
Time frame: 5 years
No Patient-reported sensitivity to hot and cold stimuli, sweets, clenching, and chewing related to the restoration (Alpha)
Secondary caries
Time frame: 5 years
No visual evidence of dark, deep discoloration adjacent to the restoration (Alpha)
Proximal contact
Time frame: 5 years
No open contact. Contact offers resistance to the dental floss (Alpha)
Marginal Adaptation
Time frame: 5 years
Restoration closely adapted to the tooth. No crevice visible (Alpha)
Fracture restoration
Time frame: 5 years
No evidence of fracture (Alpha)
Fracture tooth
Time frame: 5 years
No evidence of fracture (Alpha)
Anatomy
Time frame: 5 years
Restorations continuous with existing anatomic form (Alpha)
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 28 Apr 2021.
- Background: PubMed 23215545Cetin AR, Unlu N, Cobanoglu N. A five-year clinical evaluation of direct nanofilled and indirect composite resin restorations in posterior teeth. Oper Dent. 2013 Mar-Apr;38(2):E1-11. doi: 10.2341/12-160-C. Epub 2012 Dec 5.
- Results publication: PubMed 8258583Mjor IA, Jokstad A. Five-year study of Class II restorations in permanent teeth using amalgam, glass polyalkenoate (ionomer) cerment and resin-based composite materials. J Dent. 1993 Dec;21(6):338-43. doi: 10.1016/0300-5712(93)90006-c.
- Results publication: PubMed 19085213Vidnes-Kopperud S, Tveit AB, Gaarden T, Sandvik L, Espelid I. Factors influencing dentists' choice of amalgam and tooth-colored restorative materials for Class II preparations in younger patients. Acta Odontol Scand. 2009;67(2):74-9. doi: 10.1080/00016350802577800.
- Results publication: PubMed 22546263Correa MB, Peres MA, Peres KG, Horta BL, Barros AD, Demarco FF. Amalgam or composite resin? Factors influencing the choice of restorative material. J Dent. 2012 Sep;40(9):703-10. doi: 10.1016/j.jdent.2012.04.020. Epub 2012 Apr 28.
- Results publication: PubMed 24683067Rasines Alcaraz MG, Veitz-Keenan A, Sahrmann P, Schmidlin PR, Davis D, Iheozor-Ejiofor Z. Direct composite resin fillings versus amalgam fillings for permanent or adult posterior teeth. Cochrane Database Syst Rev. 2014 Mar 31;(3):CD005620. doi: 10.1002/14651858.CD005620.pub2.
- Results publication: PubMed 23550914Rho YJ, Namgung C, Jin BH, Lim BS, Cho BH. Longevity of direct restorations in stress-bearing posterior cavities: a retrospective study. Oper Dent. 2013 Nov-Dec;38(6):572-82. doi: 10.2341/12-432-C. Epub 2013 Apr 3.
- Results publication: PubMed 26091581Beck F, Lettner S, Graf A, Bitriol B, Dumitrescu N, Bauer P, Moritz A, Schedle A. Survival of direct resin restorations in posterior teeth within a 19-year period (1996-2015): A meta-analysis of prospective studies. Dent Mater. 2015 Aug;31(8):958-85. doi: 10.1016/j.dental.2015.05.004. Epub 2015 Jun 16.
- Results publication: PubMed 28513897Borgia E, Baron R, Borgia JL. Quality and Survival of Direct Light-Activated Composite Resin Restorations in Posterior Teeth: A 5- to 20-Year Retrospective Longitudinal Study. J Prosthodont. 2019 Jan;28(1):e195-e203. doi: 10.1111/jopr.12630. Epub 2017 May 17.
- Individual participant dataSharing planned: Undecided
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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.
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 Dental Caries Class II, run by Western University, Canada at 1 site in Canada.
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 1 inclusion and 3 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 28 Apr 2021. 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 Canada. 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?
Postoperative sensitivity (time frame: 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827823, which also lists 8 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 28 Apr 2021.