Dental CariesNCT04293770
Clinical Evaluation of Posterior Indirect Adhesive Restorations
A study testing Indirect adhesive restoration of posterior teeth in people with Dental Caries and Endodontically Treated Teeth, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Endodontically Treated Teeth, Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Indirect adhesive restoration of posterior teeth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2019to 8 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Significant loss of dental hard tissue
- Endodontically treated teeth in posterior region
- Replacement of large compromised existing restoration
- Large Class II restoration
- Age of 18-60 years
- Good oral hygiene
Show all 9Show fewer
- Presence of interproximal contact to at least one neighboring teeth
- In occlusion with antagonist teeth
- Cavity preparation with at least one cuspal coverage
Who cannot join
- Serious medical problems or allergies to substances and/or products to be used
- Severe periodontal problems
- Poor oral hygiene
- Direct pulp capping
- Presence of parafunctional behaviors
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Okan University Faculty of Dentistry
Istanbul, Tuzla, 34959
About this study
Official title: Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin: A 3-year Study
Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years.
Read the detailed description
Indirect adhesive restorations are indicated in large Class II defects, replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required. The need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes, but also have possibility of strengthening the remaining tooth structure. Indirect technique decreases polymerization shrinkage, reduces microleakage and also improves the marginal seal when comparing direct resin composites. Furthermore, it provides improved physical and mechanical properties, ideal occlusal morphology, more precise control of proximal contours and contacts. Indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement. Updated approaches now include the use of composite resins as luting agent.
This study will be carried out as a prospective study, with assessment of the restorations after three years. PASS 11 Software was used to calculate the sample size. At least 77 indirect adhesive restorations will be included for this study. Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study. 83 indirect adhesive restorations in at least 60 patients will be included. The patients who will not meet all the inclusion criteria will be excluded from the study. A signed informed consent form will be obtained from all patients before beginning the study.
Restorations will be evaluated clinically and radiographically according to FDI World Dental Federation criteria over 3-year period. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5. Statistical analysis will be performed using R (v.3.5.3) Software and the SIGN.test function in the BSDA package (p <0.05).
- Conditions
- Dental Caries, Endodontically Treated Teeth, Dental Restoration Failure of Marginal Integrity, Wear, Occlusal, Indirect Posterior Restoration
- Being tested
- Indirect adhesive restoration of posterior teeth
- Keywords
- Indirect restoration, Adhesive restoration, Cementation, Composite resin
- Medical subject headings
- Dental Caries, Tooth, Nonvital, Tooth Attrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect adhesive restoration of posterior teethDevice
Also called Ceramic onlay or overlay
Indirect restoration of significant loss of dental hard tissue
| Study group | Role | What they receive |
|---|---|---|
| Indirect restorations luted with light-cured composite resin. | Experimental | Subjects for the study will be identified from patients who had treated with indirect adhesive restorations onlay or overlay during the period 2016 to 2017 was performed at Istanbul Okan University Faculty of Dentistry by an experienced clinician.
Local anesthesia was applied if necessary. After caries and/or failed restorations were removed, the preparations were performed according to defined principles for adhesive onlays/overlays. At least one cuspal coverage was required for each restoration. All undercuts were eliminated using composite resin. Following the cavity preparation, immediate dentin sealing was applied and polymerized prior to impression taking. Indirect restorations were designed and fabricated with CEREC system. Surface treatments and clinical protocols were performed under manufacturer's instructions. Adhesive cementation with composite resin procedure was carried out with the rubber-dam isolation. Receives: Device: Indirect adhesive restoration of posterior teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI World Dental Federation criteria
Restorations will be evaluated clinically using dental explorer, mirror, dental loupe and radiographically according to FDI World Dental Federation criteria over 3-year period. Two calibrated observers who are not involved in the placement of the restorations are responsible for the evaluations.
Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form
Functional properties: Fracture of material and retention, marginal adaptation, occlusal contour and wear, approximal anatomical form, radiographic examination, patient's view.
Biological properties: Recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health.
Measured: at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start10 Dec 2019
- Primary completion8 Jun 2020 (estimated)
- Study completion8 Jul 2020 (estimated)
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 Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Prospective Clinical Trial
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah YENIER, Okan University
- Investigators
- Gulsah YENIER, DDS, PHD, Principal investigator, Istanbul Okan University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293770
- Sponsor's protocol ID
- 2020/28
- Status last verified
- Mar 2020
- First submitted
- 29 Feb 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. doi: 10.1007/s00784-013-1001-8. Epub 2013 May 22.
PubMed 23695612Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230.
PubMed 28653051Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PubMed 20628774Magne P, Razaghy M, Carvalho MA, Soares LM. Luting of inlays, onlays, and overlays with preheated restorative composite resin does not prevent seating accuracy. Int J Esthet Dent. 2018;13(3):318-332.
PubMed 30073216D'Arcangelo C, Vanini L, Casinelli M, Frascaria M, De Angelis F, Vadini M, D'Amario M. Adhesive Cementation of Indirect Composite Inlays and Onlays: A Literature Review. Compend Contin Educ Dent. 2015 Sep;36(8):570-7; quiz 578.
PubMed 26355440Naeselius K, Arnelund CF, Molin MK. Clinical evaluation of all-ceramic onlays: a 4-year retrospective study. Int J Prosthodont. 2008 Jan-Feb;21(1):40-4.
PubMed 18350945
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin: A 3-year Study
- ClinicalTrials.gov ID
- NCT04293770
- Acronym / sponsor ID
- 2020/28
- Conditions
- Dental Caries, Endodontically Treated Teeth, Dental Restoration Failure of Marginal Integrity, Wear, Occlusal, Indirect Posterior Restoration
- Keywords
- Indirect restoration, Adhesive restoration, Cementation, Composite resin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 8 Jun 2020 (estimated)
- Study completion
- 8 Jul 2020 (estimated)
- First posted
- 3 Mar 2020 (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.
Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years.
Detailed description
Indirect adhesive restorations are indicated in large Class II defects, replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required. The need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes, but also have possibility of strengthening the remaining tooth structure. Indirect technique decreases polymerization shrinkage, reduces microleakage and also improves the marginal seal when comparing direct resin composites. Furthermore, it provides improved physical and mechanical properties, ideal occlusal morphology, more precise control of proximal contours and contacts. Indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement. Updated approaches now include the use of composite resins as luting agent.
This study will be carried out as a prospective study, with assessment of the restorations after three years. PASS 11 Software was used to calculate the sample size. At least 77 indirect adhesive restorations will be included for this study. Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study. 83 indirect adhesive restorations in at least 60 patients will be included. The patients who will not meet all the inclusion criteria will be excluded from the study. A signed informed consent form will be obtained from all patients before beginning the study.
Restorations will be evaluated clinically and radiographically according to FDI World Dental Federation criteria over 3-year period. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5. Statistical analysis will be performed using R (v.3.5.3) Software and the SIGN.test function in the BSDA package (p <0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Prospective Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Indirect restorations luted with light-cured composite resin. | Experimental | Device: Indirect adhesive restoration of posterior teethSubjects for the study will be identified from patients who had treated with indirect adhesive restorations onlay or overlay during the period 2016 to 2017 was performed at Istanbul Okan University Faculty of Dentistry by an experienced clinician. Local anesthesia was applied if necessary. After caries and/or failed restorations were removed, the preparations were performed according to defined principles for adhesive onlays/overlays. At least one cuspal coverage was required for each restoration. All undercuts were eliminated using composite resin. Following the cavity preparation, immediate dentin sealing was applied and polymerized prior to impression taking. Indirect restorations were designed and fabricated with CEREC system. Surface treatments and clinical protocols were performed under manufacturer's instructions. Adhesive cementation with composite resin procedure was carried out with the rubber-dam isolation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Significant loss of dental hard tissue
- Endodontically treated teeth in posterior region
- Replacement of large compromised existing restoration
- Large Class II restoration
- Age of 18-60 years
Key exclusion criteria (6 listed)
- Serious medical problems or allergies to substances and/or products to be used
- Severe periodontal problems
- Poor oral hygiene
- Direct pulp capping
- Presence of parafunctional behaviors
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 |
|---|---|---|
| Indirect adhesive restoration of posterior teethAlso: Ceramic onlay or overlayIndirect restoration of significant loss of dental hard tissue | Device | Indirect restorations luted with light-cured composite resin. |
Primary outcome
FDI World Dental Federation criteria
Time frame: at 3 years
Restorations will be evaluated clinically using dental explorer, mirror, dental loupe and radiographically according to FDI World Dental Federation criteria over 3-year period. Two calibrated observers who are not involved in the placement of the restorations are responsible for the evaluations. Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form Functional properties: Fracture of material and retention, marginal adaptation, occlusal contour and wear, approximal anatomical form, radiographic examination, patient's view. Biological properties: Recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Background: PubMed 23695612D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. doi: 10.1007/s00784-013-1001-8. Epub 2013 May 22.
- Background: PubMed 28653051Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230.
- Background: PubMed 20628774Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
- Background: PubMed 30073216Magne P, Razaghy M, Carvalho MA, Soares LM. Luting of inlays, onlays, and overlays with preheated restorative composite resin does not prevent seating accuracy. Int J Esthet Dent. 2018;13(3):318-332.
- Background: PubMed 26355440D'Arcangelo C, Vanini L, Casinelli M, Frascaria M, De Angelis F, Vadini M, D'Amario M. Adhesive Cementation of Indirect Composite Inlays and Onlays: A Literature Review. Compend Contin Educ Dent. 2015 Sep;36(8):570-7; quiz 578.
- Background: PubMed 18350945Naeselius K, Arnelund CF, Molin MK. Clinical evaluation of all-ceramic onlays: a 4-year retrospective study. Int J Prosthodont. 2008 Jan-Feb;21(1):40-4.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Gulsah YENIER, DDS, PHD principal investigator
Istanbul Okan University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect adhesive restoration of posterior teeth in people with Dental Caries and Endodontically Treated Teeth, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Mar 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gulsah YENIER, DDS,PhD (+905547810176, gulsahyenier@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDI World Dental Federation criteria (time frame: at 3 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 NCT04293770, 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 5 Mar 2020.