Unsatisfactory or Defective Restoration of ToothNCT06457737
The Performance of Posterior Partial Coverage Coronal Restorations Luted With Two Differrent Systems.
A study testing IPS Empress Direct and Bisco Duo-Link Universal in people with Unsatisfactory or Defective Restoration of Tooth, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth. It will follow a split-mouth design with 60 participants selected based on strict criteria. 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
- What is being tested?
- IPS Empress Direct and Bisco Duo-Link Universal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteJordan
- Study dates
- 1 May 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Consenting participants.
- Individuals aged 18 years and above with no systemic diseases that will affect their participation.
- Teeth of healthy periodontium.
- Teeth to be restored in normal occlusion with natural antagonist and adjacent teeth.
- Acceptable oral hygiene characterized by no gingivitis, calculus deposit or active carious lesions.
- Non-vital teeth will be included
Who cannot join
- Heavy occlusal contacts or signs of bruxism.
- Profound, chronic periodontitis
- Poor oral hygiene.
- Sustained dentin hypersensitivity.
- Systemic disease or severe medical complications or taking anti-inflammatory, analgesic, or psychotropic drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid, 21110
Zakereyya SM Albashaireh, PhD, 0791015505, albashai@just.edu.jo
About this study
Official title: The Performance of Posterior Partial Coverage Coronal Restorations Cemented Using Two Different Luting Systems. A Comparative Clinical Trial.
This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth. It will follow a split-mouth design with 60 participants selected based on strict criteria. Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.
The null hypothesis:
The use of preheated resin composite for cementing partial coverage restoration will not result in significantly superior clinical performance when compared to that after using dual-cure resin cement.
Read the detailed description
The adhesive cementation of ceramic partial coverage restorations is a technique-sensitive process essential for achieving optimal retention and marginal integrity. While dental resin cements are commonly used for adhesive luting of indirect ceramic restorations, concerns exist regarding their long-term reliability due to susceptibility to degradation over time and polymerization shrinkage-related issues.
This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth, aiming to address these drawbacks. It will follow a split-mouth design with 60 participants selected based on strict criteria. The preparation and delivery appointments follow specific guidelines, incorporating the Morphology Driven Preparation Technique (MDPT). Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.
The objectives of this clinical trial are to evaluate the clinical performance of posterior partial coverage coronal restorations utilizing two different luting systems (preheated resin-based composite versus conventional dual-cure resin cement) in a split-mouth study design.
- Being tested
- IPS Empress Direct, Bisco Duo-Link Universal
- Keywords
- Endodontically treated teeth, Partial coverage, Ceramic restorations, Luting systems, Preheated composite, Dual cure adhesive resin cement
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPS Empress DirectDevice
Also called Ivoclar Vivadent, Schaan, Liechtenstein
Resin composite will be heated and used to lute a ceramic partial coverage restoration.
Bisco Duo-Link UniversalDevice
Also called Bisco, USA
Dual cure adhesive resin cement will be used to lute a ceramic partial coverage restoration.
| Study group | Role | What they receive |
|---|---|---|
| Preheated resin composite (IPS Empress Direct) group | Experimental | Endodontically treated teeth will be prepared to receive partial coverage ceramic restorations that will be luted with preheated composite. Receives: Device: IPS Empress Direct |
| Dual-cure adhesive resin cement (Bisco Duo-Link Universal) group | Experimental | Endodontically treated teeth will be prepared to receive partial coverage ceramic restorations that will be luted with dual-cure adhesive resin cement. Receives: Device: Bisco Duo-Link Universal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.
Clinical examination and evaluation of the adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta and Echo.
Alpha score means: restoration contour is continuous with the existing anatomical margin of the tooth.
Beta score means: restoration is slightly under or over contoured.
Charlie score means: marginal overhang or tooth structure (dentin or enamel) is exposed.
Delta score means: restoration is missing, or traumatic occlusion, or restoration causes pain.
Measured: 1 year
Clinical evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.
Clinical examination and evaluation of the caries presence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta.
Alpha score means: No visible caries
Beta score means: caries present
Measured: 1 year
Clinical evaluation of the performance of marginal adaptation of posterior partial coverage ceramic restoration.
Clinical examination and evaluation of the marginal adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta.
Alpha score means: Excellent continuity at resin-enamel interface, no ledge formation, no discoloration
Beta score means: Slight discoloration at resin-enamel interface; ledge at interafce.
Charlie score means: Moderate discoloration at resin-enamel interface measuring 1mm or greater.
Delta score means: Recurrent caries at margins.
Measured: 1 year
Clinical evaluation of surface staining of posterior partial coverage ceramic restoration.
Clinical examination and evaluation of the presence or absence of surface staining of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta.
Alpha score means: staining absent
Beta score means: staining present
Measured: 1 year
Clinical evaluation of contact points of posterior partial coverage ceramic restoration.
Clinical examination and evaluation of the contact points quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta.
Alpha score means: contact point present
Beta score means: contact point absent.
Measured: 1 year
Clinical evaluation of fracture of posterior partial coverage ceramic restoration.
Clinical examination and evaluation of the structural integrity endurance of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta, Echo.
Alpha score means: No fracture of the restoration.
Beta score means: Small chipping (1/4 of restoration)
Charlie score means: Moderate chipping (1/2 of restoration)
Delta score means: Severe chipping (3/4 of restoration)
Echo score means: loss of the restoration.
Measured: 1 year
Clinical evaluation of wear of posterior partial coverage ceramic restoration.
Clinical examination and evaluation of the wear presence or absence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta.
Alpha score means: absence of wear.
Beta score means: wear present.
Measured: 1 year
Radiographic evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.
Radiographic examination and evaluation of the adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta and Echo.
Alpha score means: restoration contour is continuous with the existing anatomical margin of the tooth.
Beta score means: restoration is slightly under or over contoured.
Charlie score means: marginal overhang or tooth structure (dentin or enamel) is exposed.
Delta score means: restoration is missing.
Measured: 1 year
Radiographic evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.
Radiographic examination and evaluation of the caries presence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta.
Alpha score means: No visible caries
Beta score means: caries present
Measured: 1 year
Radiographic evaluation of marginal adaptation of posterior partial coverage ceramic restoration.
Radiographic examination and evaluation of the marginal adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta.
Alpha score means: Excellent continuity at resin-enamel interface, no ledge formation, no discoloration
Beta score means: Slight discoloration at resin-enamel interface; ledge at interafce.
Charlie score means: Moderate discoloration at resin-enamel interface measuring 1mm or greater.
Delta score means: Recurrent caries at margins.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 May 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth study design, patients will be assigned to two different treatment protocols.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zakereyya SM Albashaireh, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457737
- Sponsor's protocol ID
- 20240137
- Status last verified
- Mar 2025
- First submitted
- 3 Jun 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A consent has to be obtained from the faculty of graduate studies for sharing data as data form part of graduate students thesis.
Publications
Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230.
PubMed 28653051Rickman LJ, Padipatvuthikul P, Chee B. Clinical applications of preheated hybrid resin composite. Br Dent J. 2011 Jul 22;211(2):63-7. doi: 10.1038/sj.bdj.2011.571.
PubMed 21779058Ayub KV, Santos GC Jr, Rizkalla AS, Bohay R, Pegoraro LF, Rubo JH, Santos MJ. Effect of preheating on microhardness and viscosity of 4 resin composites. J Can Dent Assoc. 2014;80:e12.
PubMed 24598328Mundim FM, Garcia Lda F, Cruvinel DR, Lima FA, Bachmann L, Pires-de-Souza Fde C. Color stability, opacity and degree of conversion of pre-heated composites. J Dent. 2011 Jul;39 Suppl 1:e25-9. doi: 10.1016/j.jdent.2010.12.001. Epub 2010 Dec 14.
PubMed 21163324da Costa JB, Hilton TJ, Swift EJ Jr. Critical appraisal: preheating composites. J Esthet Restor Dent. 2011 Aug;23(4):269-75. doi: 10.1111/j.1708-8240.2011.00461.x. Epub 2011 Jun 22.
PubMed 21806761Marcondes RL, Lima VP, Barbon FJ, Isolan CP, Carvalho MA, Salvador MV, Lima AF, Moraes RR. Viscosity and thermal kinetics of 10 preheated restorative resin composites and effect of ultrasound energy on film thickness. Dent Mater. 2020 Oct;36(10):1356-1364. doi: 10.1016/j.dental.2020.08.004. Epub 2020 Sep 1.
PubMed 32888725Patussi AFC, Ramacciato JC, da Silva JGR, Nascimento VRP, Campos DES, de Araujo Ferreira Munizz I, de Souza GM, Lima RBW. Preheating of dental composite resins: A scoping review. J Esthet Restor Dent. 2023 Jun;35(4):646-656. doi: 10.1111/jerd.12991. Epub 2022 Dec 7.
PubMed 36478368Magne 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 30073216Coelho NF, Barbon FJ, Machado RG, Boscato N, Moraes RR. Response of composite resins to preheating and the resulting strengthening of luted feldspar ceramic. Dent Mater. 2019 Oct;35(10):1430-1438. doi: 10.1016/j.dental.2019.07.021. Epub 2019 Aug 3.
PubMed 31387743Gresnigt MMM, Ozcan M, Carvalho M, Lazari P, Cune MS, Razavi P, Magne P. Effect of luting agent on the load to failure and accelerated-fatigue resistance of lithium disilicate laminate veneers. Dent Mater. 2017 Dec;33(12):1392-1401. doi: 10.1016/j.dental.2017.09.010. Epub 2017 Nov 1.
PubMed 29079354Skapska A, Komorek Z, Cierech M, Mierzwinska-Nastalska E. Comparison of Mechanical Properties of a Self-Adhesive Composite Cement and a Heated Composite Material. Polymers (Basel). 2022 Jun 30;14(13):2686. doi: 10.3390/polym14132686.
PubMed 35808732Falacho RI, Marques JA, Palma PJ, Roseiro L, Caramelo F, Ramos JC, Guerra F, Blatz MB. Luting indirect restorations with resin cements versus composite resins: Effects of preheating and ultrasound energy on film thickness. J Esthet Restor Dent. 2022 Jun;34(4):641-649. doi: 10.1111/jerd.12851. Epub 2021 Dec 13.
PubMed 34897958Goujat A, Abouelleil H, Colon P, Jeannin C, Pradelle N, Seux D, Grosgogeat B. Marginal and internal fit of CAD-CAM inlay/onlay restorations: A systematic review of in vitro studies. J Prosthet Dent. 2019 Apr;121(4):590-597.e3. doi: 10.1016/j.prosdent.2018.06.006. Epub 2018 Dec 1.
PubMed 30509548Schmidlin PR, Zehnder M, Schlup-Mityko C, Gohring TN. Interface evaluation after manual and ultrasonic insertion of standardized class I inlays using composite resin materials of different viscosity. Acta Odontol Scand. 2005 Aug;63(4):205-12. doi: 10.1080/00016350510019973.
PubMed 16040442Magne P. Immediate dentin sealing: a fundamental procedure for indirect bonded restorations. J Esthet Restor Dent. 2005;17(3):144-54; discussion 155. doi: 10.1111/j.1708-8240.2005.tb00103.x.
PubMed 15996383
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of Posterior Partial Coverage Coronal Restorations Cemented Using Two Different Luting Systems. A Comparative Clinical Trial.
- ClinicalTrials.gov ID
- NCT06457737
- Acronym / sponsor ID
- 20240137
- Keywords
- Endodontically treated teeth, Partial coverage, Ceramic restorations, Luting systems, Preheated composite, Dual cure adhesive resin cement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 13 Jun 2024 (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 study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth. It will follow a split-mouth design with 60 participants selected based on strict criteria. Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.
The null hypothesis:
The use of preheated resin composite for cementing partial coverage restoration will not result in significantly superior clinical performance when compared to that after using dual-cure resin cement.
Detailed description
The adhesive cementation of ceramic partial coverage restorations is a technique-sensitive process essential for achieving optimal retention and marginal integrity. While dental resin cements are commonly used for adhesive luting of indirect ceramic restorations, concerns exist regarding their long-term reliability due to susceptibility to degradation over time and polymerization shrinkage-related issues.
This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth, aiming to address these drawbacks. It will follow a split-mouth design with 60 participants selected based on strict criteria. The preparation and delivery appointments follow specific guidelines, incorporating the Morphology Driven Preparation Technique (MDPT). Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.
The objectives of this clinical trial are to evaluate the clinical performance of posterior partial coverage coronal restorations utilizing two different luting systems (preheated resin-based composite versus conventional dual-cure resin cement) in a split-mouth study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth study design, patients will be assigned to two different treatment protocols.
| Arm | Type | Receives |
|---|---|---|
| Preheated resin composite (IPS Empress Direct) group | Experimental | Device: IPS Empress DirectEndodontically treated teeth will be prepared to receive partial coverage ceramic restorations that will be luted with preheated composite. |
| Dual-cure adhesive resin cement (Bisco Duo-Link Universal) group | Experimental | Device: Bisco Duo-Link UniversalEndodontically treated teeth will be prepared to receive partial coverage ceramic restorations that will be luted with dual-cure adhesive resin cement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consenting participants.
- Individuals aged 18 years and above with no systemic diseases that will affect their participation.
- Teeth of healthy periodontium.
- Teeth to be restored in normal occlusion with natural antagonist and adjacent teeth.
- Acceptable oral hygiene characterized by no gingivitis, calculus deposit or active carious lesions.
Key exclusion criteria (5 listed)
- Heavy occlusal contacts or signs of bruxism.
- Profound, chronic periodontitis
- Poor oral hygiene.
- Sustained dentin hypersensitivity.
- Systemic disease or severe medical complications or taking anti-inflammatory, analgesic, or psychotropic drugs.
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 |
|---|---|---|
| IPS Empress DirectAlso: Ivoclar Vivadent, Schaan, LiechtensteinResin composite will be heated and used to lute a ceramic partial coverage restoration. | Device | Preheated resin composite (IPS Empress Direct) group |
| Bisco Duo-Link UniversalAlso: Bisco, USADual cure adhesive resin cement will be used to lute a ceramic partial coverage restoration. | Device | Dual-cure adhesive resin cement (Bisco Duo-Link Universal) group |
Primary outcome
Clinical evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.
Time frame: 1 year
Clinical examination and evaluation of the adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta and Echo. Alpha score means: restoration contour is continuous with the existing anatomical margin of the tooth. Beta score means: restoration is slightly under or over contoured. Charlie score means: marginal overhang or tooth structure (dentin or enamel) is exposed. Delta score means: restoration is missing, or traumatic occlusion, or restoration causes pain.
Clinical evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.
Time frame: 1 year
Clinical examination and evaluation of the caries presence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: No visible caries Beta score means: caries present
Clinical evaluation of the performance of marginal adaptation of posterior partial coverage ceramic restoration.
Time frame: 1 year
Clinical examination and evaluation of the marginal adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta. Alpha score means: Excellent continuity at resin-enamel interface, no ledge formation, no discoloration Beta score means: Slight discoloration at resin-enamel interface; ledge at interafce. Charlie score means: Moderate discoloration at resin-enamel interface measuring 1mm or greater. Delta score means: Recurrent caries at margins.
Clinical evaluation of surface staining of posterior partial coverage ceramic restoration.
Time frame: 1 year
Clinical examination and evaluation of the presence or absence of surface staining of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: staining absent Beta score means: staining present
Clinical evaluation of contact points of posterior partial coverage ceramic restoration.
Time frame: 1 year
Clinical examination and evaluation of the contact points quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: contact point present Beta score means: contact point absent.
Clinical evaluation of fracture of posterior partial coverage ceramic restoration.
Time frame: 1 year
Clinical examination and evaluation of the structural integrity endurance of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta, Echo. Alpha score means: No fracture of the restoration. Beta score means: Small chipping (1/4 of restoration) Charlie score means: Moderate chipping (1/2 of restoration) Delta score means: Severe chipping (3/4 of restoration) Echo score means: loss of the restoration.
Clinical evaluation of wear of posterior partial coverage ceramic restoration.
Time frame: 1 year
Clinical examination and evaluation of the wear presence or absence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: absence of wear. Beta score means: wear present.
Radiographic evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.
Time frame: 1 year
Radiographic examination and evaluation of the adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta and Echo. Alpha score means: restoration contour is continuous with the existing anatomical margin of the tooth. Beta score means: restoration is slightly under or over contoured. Charlie score means: marginal overhang or tooth structure (dentin or enamel) is exposed. Delta score means: restoration is missing.
Radiographic evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.
Time frame: 1 year
Radiographic examination and evaluation of the caries presence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: No visible caries Beta score means: caries present
Radiographic evaluation of marginal adaptation of posterior partial coverage ceramic restoration.
Time frame: 1 year
Radiographic examination and evaluation of the marginal adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta. Alpha score means: Excellent continuity at resin-enamel interface, no ledge formation, no discoloration Beta score means: Slight discoloration at resin-enamel interface; ledge at interafce. Charlie score means: Moderate discoloration at resin-enamel interface measuring 1mm or greater. Delta score means: Recurrent caries at margins.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- 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 21779058Rickman LJ, Padipatvuthikul P, Chee B. Clinical applications of preheated hybrid resin composite. Br Dent J. 2011 Jul 22;211(2):63-7. doi: 10.1038/sj.bdj.2011.571.
- Background: PubMed 24598328Ayub KV, Santos GC Jr, Rizkalla AS, Bohay R, Pegoraro LF, Rubo JH, Santos MJ. Effect of preheating on microhardness and viscosity of 4 resin composites. J Can Dent Assoc. 2014;80:e12.
- Background: PubMed 21163324Mundim FM, Garcia Lda F, Cruvinel DR, Lima FA, Bachmann L, Pires-de-Souza Fde C. Color stability, opacity and degree of conversion of pre-heated composites. J Dent. 2011 Jul;39 Suppl 1:e25-9. doi: 10.1016/j.jdent.2010.12.001. Epub 2010 Dec 14.
- Background: PubMed 21806761da Costa JB, Hilton TJ, Swift EJ Jr. Critical appraisal: preheating composites. J Esthet Restor Dent. 2011 Aug;23(4):269-75. doi: 10.1111/j.1708-8240.2011.00461.x. Epub 2011 Jun 22.
- Background: PubMed 32888725Marcondes RL, Lima VP, Barbon FJ, Isolan CP, Carvalho MA, Salvador MV, Lima AF, Moraes RR. Viscosity and thermal kinetics of 10 preheated restorative resin composites and effect of ultrasound energy on film thickness. Dent Mater. 2020 Oct;36(10):1356-1364. doi: 10.1016/j.dental.2020.08.004. Epub 2020 Sep 1.
- Background: PubMed 36478368Patussi AFC, Ramacciato JC, da Silva JGR, Nascimento VRP, Campos DES, de Araujo Ferreira Munizz I, de Souza GM, Lima RBW. Preheating of dental composite resins: A scoping review. J Esthet Restor Dent. 2023 Jun;35(4):646-656. doi: 10.1111/jerd.12991. Epub 2022 Dec 7.
- 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 31387743Coelho NF, Barbon FJ, Machado RG, Boscato N, Moraes RR. Response of composite resins to preheating and the resulting strengthening of luted feldspar ceramic. Dent Mater. 2019 Oct;35(10):1430-1438. doi: 10.1016/j.dental.2019.07.021. Epub 2019 Aug 3.
- Background: PubMed 29079354Gresnigt MMM, Ozcan M, Carvalho M, Lazari P, Cune MS, Razavi P, Magne P. Effect of luting agent on the load to failure and accelerated-fatigue resistance of lithium disilicate laminate veneers. Dent Mater. 2017 Dec;33(12):1392-1401. doi: 10.1016/j.dental.2017.09.010. Epub 2017 Nov 1.
- Background: PubMed 35808732Skapska A, Komorek Z, Cierech M, Mierzwinska-Nastalska E. Comparison of Mechanical Properties of a Self-Adhesive Composite Cement and a Heated Composite Material. Polymers (Basel). 2022 Jun 30;14(13):2686. doi: 10.3390/polym14132686.
- Background: PubMed 34897958Falacho RI, Marques JA, Palma PJ, Roseiro L, Caramelo F, Ramos JC, Guerra F, Blatz MB. Luting indirect restorations with resin cements versus composite resins: Effects of preheating and ultrasound energy on film thickness. J Esthet Restor Dent. 2022 Jun;34(4):641-649. doi: 10.1111/jerd.12851. Epub 2021 Dec 13.
- Sealed Envelope Ltd. 2012. Power calculator for binary outcome superiority trial. \[Online\]Link provided by the sponsor.
- Individual participant dataSharing planned: No. A consent has to be obtained from the faculty of graduate studies for sharing data as data form part of graduate students thesis.
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.
Zakereyya SM Albashaireh, PhD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPS Empress Direct and Bisco Duo-Link Universal in people with Unsatisfactory or Defective Restoration of Tooth, run by King Abdullah University Hospital at 1 site in Jordan.
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 6 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zakereyya SM Albashaireh, PhD (0791015505, albashai@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration. (time frame: 1 year). The study lists 10 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 NCT06457737, which also lists 15 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 14 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.