Cementation TeethNCT05954156
Injectable Resin Composite Versus Dual-cured Resin Cement for Cementation of Indirect Onlay Restorations
A study testing Injectable restorative resin composite and Dual cured resin cement in people with Cementation Teeth and Badly Broken Down Vital Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
Marginal integrity is considered the main essential part of indirect restorations and any discrepancy after cementation and poor marginal fit can lead to microleakage, marginal discoloration, dissolution of cement and secondary caries. Read more about this study
- Who is it for?
- Ages 22 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cementation Teeth, Badly Broken Down Vital Teeth
- What is being tested?
- Injectable restorative resin composite and Dual cured resin cement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 28 Feb 2025
- 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 22 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with vital, asymptomatic, badly broken-down lower molar exhibiting at least two missing walls and one or more weakened or absent cusps (indicated for an onlay restoration), classified as ICDAS score (5)
- Patients with at least 20 teeth under occlusion.
- Age: 20-40 years.
- Males or females.
- Co-operative patients approving to participate in the trial.
- Good oral hygiene measures
- Teeth with no signs of pulpal involvement; healthy periodontal status; favorable occlusion
- Those in good general health.
Who cannot join
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis or periapical pathosis
- Teeth supporting removable prostheses, or orthodontic appliances.
- Candidates with parafunction or bruxism or temporomandibular joint disorders
- Candidates with systemic diseases or disabilities that may affect participation.
- Heavy smoking.
- Pregnancy.
Show all 11Show fewer
- Lack of compliance.
- Severe or active periodontal disease
- Non-vital or endodontically treated teeth
- Xerostomia
- Drug addiction; or any condition that could compromise study compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Injectable Resin Composite Versus Dual Cured Resin Cement For Cementation of Indirect Hybrid Ceramic Onlay Restorations: A Randomized Clinical Trial
Marginal integrity is considered the main essential part of indirect restorations and any discrepancy after cementation and poor marginal fit can lead to microleakage, marginal discoloration, dissolution of cement and secondary caries. The type of cement used plays an important role and can govern the amount of augmentation in discrepancy after cementation.
Although resin cement is still the gold standard luting agent for the cementation of all indirect restoration, it lacks some properties that may be available in the restorative resin composite such as higher filler loading, higher mechanical properties and wear resistance.
may have been the first to propose the use of restorative, flowable resin composite as a luting agent for ceramic inlays. These authors demonstrated that with respect to polymerization rate, there were no advantages of dual curing-resin compared to light curing only. In addition, the overall handling of the light-curing flowable restorative resin composite was judged to be easier than that of the dual cured material. The same conclusions were drawn by Kramer and franken Berger who added that less luting resin composite overhangs were found with the light polymerized composite-resin because the clinician has more time for excess removal prior to polymerization. The claimed further potential advantages of using restorative rein composite as a luting agent is their resistance to wear which proved to be superior to resin cements
Read the detailed description
the author presented a review on the updates of dental cements, focusing on the composition, properties, advantages, limitations, and indications of the various cements available. Nowadays, dental restorations are made from various biomaterials, and depending on each clinical case, an appropriate luting material will be selected. There is no luting material that can be universally used. Therefore, it is important to distinguish the physical, mechanical, and biological properties of luting materials in order to identify the best options for each case. Nowadays, the most commonly used dental cements are glass-ionomer and resin cement. The type, shade, thickness of resin cement and the shade of the ceramic, all together, have a tangible influence on the final restoration color. Surface treatments of the restoration increase the micro tensile bond strength. Hence, the proper surface treatment protocol of both the substrate and restoration surfaces is needed before cementation. Additionally, the manufacturer's instructions for the thin cement-layer thickness are important for the long-term success of the restoration.
the author conducted a study to evaluate the performance of two different adhesive resin cement systems in the cementation of inlay/onlay restorations produced from resin nanoceramic blocks using the CAD/CAM system. The methodology was total of 70 inlay/onlay restorations made from Cerasmart (GC, Tokyo, Japan) resin nanoceramic blocks using CEREC Omnicam (Sirona Dental, Bensheim, Germany) were placed in 53 patients. The restorations were cemented with RelyX U200 Automix (3M ESPE, Seefeld, Germany) self-adhesive resin cement (RXU) after selective enamel etching or with G-CEM LinkForce (GC, Tokyo, Japan) adhesive resin cement (GCL) in combination with a universal adhesive (G-Premio Bond) in selective etch mode. At baseline and after 6, 12, and 18 months, restorations were examined by two calibrated clinicians according to modified USPHS criteria. . he concluded that the two resin cement systems showed acceptable clinical performance for the cementation of resin nanoceramic CEREC Omnicam inlay
the author conducted a study to evaluate the retention strength of zirconia crowns luted with two types of resin cement under environmental pressure changes.Thirty zirconia crowns were fabricated by using computer-aided design/computer-aided manufacturing (CAD/CAM) system and were cemented by Panavia F2.0 (PAN), hand-mixed RelyX Unicem (UNH), or auto-mix RelyX Unicem Aplicap (UNA) cements on the corresponding extracted human molars. The samples were randomly divided into three groups according to the cement type. After 3000 thermal cycles, the cemented crowns were subjected to 24 pressure cycles (0 to 5 atmospheres). The retention force (N) of the specimens was measured in a universal testing machine. To normalize the retentive force, the recorded force was divided by the surface area of each tooth for measuring the retentive strength (MPa). he concluded that. The adhesive failure mode was predominant in all the groups.
- Conditions
- Cementation Teeth, Badly Broken Down Vital Teeth
- Being tested
- Injectable restorative resin composite, Dual cured resin cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable restorative resin compositeOther
The introduction of injectable composites, according to available literature, offers a simple and efficient solution for the cementation of veneers. This versatile, injectable restorative composite unites easy handling, high physical properties and excellent aesthetics. Generally used as a restorative material, it can also be used for the cementation of veneers and some inlays/onlays, thus considered as good alternative to preheated composite. (Alajrash MM et al., 2020)
Dual cured resin cementOther
Resin cements are widely used due to their strong adhesion, and compatibility with various restorative materials, including ceramics and zirconia. They bond to enamel and dentin through functional monomers such as MDP, and 4-META, forming a stable hybrid layer. Based on their bonding mechanism, resin cements are classified as adhesive or self-adhesive, while their polymerization method -chemical, light, or dual-cure-allows for versatility in clinical applications
| Study group | Role | What they receive |
|---|---|---|
| Injectable restorative resin composite material used for cementation | Experimental | Highly filled injectable composites display properties in a manner similar to resin cements due to their unique viscosities. This with the added benefits of higher filler content, thus improved mechanical and physical properties with the easy placement and handling properties which can improve clinical performance and durability of indirect restorations. (Fugimoto et al., 2019) Receives: Other: Injectable restorative resin composite |
| Dual cured resin cement | Active comparator | Dual cured resin cement is chosen as a comparator (gold standard )for the cementation of indirect restorations. (Sadighpour et al., 2018) Resin cement is insoluble and has superior mechanical and physical properties, compared with other previous luting materials. The clinical advantages of resin cement include high resistance to compression forces, low thermal expansion coefficients, high flexural strengths, and hardness. In addition, resin cement is characterized by adhesion to many materials, the ability to modify shade and color, high retention, resistance to wear at the margin of the restoration, and low marginal permeability. Resin cement provides optimal bond with resin composite indirect restorations and evenly distributes the compression force along all contact surfaces. (Gurdal et al., 2018 Receives: Other: Dual cured resin cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance
Retention, marginal integrity, secondary caries, anatomic form, surface texture, proximal contact and postoperative hypersensitivity. All these outcomes are measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable ,charlie is not accepted
Measured: 18 months change from baseline to 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Aug 2023
- Primary completion30 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cementation TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamsa Ashraf Abd El Menam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954156
- Sponsor's protocol ID
- IRS_DCRC
- Status last verified
- Apr 2025
- First submitted
- 5 Jul 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ashraf H, El Tannir A, El Zohairy A, Kamal D. Clinical performance of indirect hybrid ceramic onlay restorations cemented with injectable resin composite versus dual-cure resin cement: an 18-month randomized clinical trial. BMC Oral Health. 2025 Sep 23;25(1):1419. doi: 10.1186/s12903-025-06903-5.
PubMed 40988059
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Injectable Resin Composite Versus Dual Cured Resin Cement For Cementation of Indirect Hybrid Ceramic Onlay Restorations: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05954156
- Acronym / sponsor ID
- IRS_DCRC
- Conditions
- Cementation Teeth, Badly Broken Down Vital Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 20 Jul 2023 (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.
Marginal integrity is considered the main essential part of indirect restorations and any discrepancy after cementation and poor marginal fit can lead to microleakage, marginal discoloration, dissolution of cement and secondary caries. The type of cement used plays an important role and can govern the amount of augmentation in discrepancy after cementation.
Although resin cement is still the gold standard luting agent for the cementation of all indirect restoration, it lacks some properties that may be available in the restorative resin composite such as higher filler loading, higher mechanical properties and wear resistance.
may have been the first to propose the use of restorative, flowable resin composite as a luting agent for ceramic inlays. These authors demonstrated that with respect to polymerization rate, there were no advantages of dual curing-resin compared to light curing only. In addition, the overall handling of the light-curing flowable restorative resin composite was judged to be easier than that of the dual cured material. The same conclusions were drawn by Kramer and franken Berger who added that less luting resin composite overhangs were found with the light polymerized composite-resin because the clinician has more time for excess removal prior to polymerization. The claimed further potential advantages of using restorative rein composite as a luting agent is their resistance to wear which proved to be superior to resin cements
Detailed description
the author presented a review on the updates of dental cements, focusing on the composition, properties, advantages, limitations, and indications of the various cements available. Nowadays, dental restorations are made from various biomaterials, and depending on each clinical case, an appropriate luting material will be selected. There is no luting material that can be universally used. Therefore, it is important to distinguish the physical, mechanical, and biological properties of luting materials in order to identify the best options for each case. Nowadays, the most commonly used dental cements are glass-ionomer and resin cement. The type, shade, thickness of resin cement and the shade of the ceramic, all together, have a tangible influence on the final restoration color. Surface treatments of the restoration increase the micro tensile bond strength. Hence, the proper surface treatment protocol of both the substrate and restoration surfaces is needed before cementation. Additionally, the manufacturer's instructions for the thin cement-layer thickness are important for the long-term success of the restoration.
the author conducted a study to evaluate the performance of two different adhesive resin cement systems in the cementation of inlay/onlay restorations produced from resin nanoceramic blocks using the CAD/CAM system. The methodology was total of 70 inlay/onlay restorations made from Cerasmart (GC, Tokyo, Japan) resin nanoceramic blocks using CEREC Omnicam (Sirona Dental, Bensheim, Germany) were placed in 53 patients. The restorations were cemented with RelyX U200 Automix (3M ESPE, Seefeld, Germany) self-adhesive resin cement (RXU) after selective enamel etching or with G-CEM LinkForce (GC, Tokyo, Japan) adhesive resin cement (GCL) in combination with a universal adhesive (G-Premio Bond) in selective etch mode. At baseline and after 6, 12, and 18 months, restorations were examined by two calibrated clinicians according to modified USPHS criteria. . he concluded that the two resin cement systems showed acceptable clinical performance for the cementation of resin nanoceramic CEREC Omnicam inlay
the author conducted a study to evaluate the retention strength of zirconia crowns luted with two types of resin cement under environmental pressure changes.Thirty zirconia crowns were fabricated by using computer-aided design/computer-aided manufacturing (CAD/CAM) system and were cemented by Panavia F2.0 (PAN), hand-mixed RelyX Unicem (UNH), or auto-mix RelyX Unicem Aplicap (UNA) cements on the corresponding extracted human molars. The samples were randomly divided into three groups according to the cement type. After 3000 thermal cycles, the cemented crowns were subjected to 24 pressure cycles (0 to 5 atmospheres). The retention force (N) of the specimens was measured in a universal testing machine. To normalize the retentive force, the recorded force was divided by the surface area of each tooth for measuring the retentive strength (MPa). he concluded that. The adhesive failure mode was predominant in all the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectable restorative resin composite material used for cementation | Experimental | Other: Injectable restorative resin compositeHighly filled injectable composites display properties in a manner similar to resin cements due to their unique viscosities. This with the added benefits of higher filler content, thus improved mechanical and physical properties with the easy placement and handling properties which can improve clinical performance and durability of indirect restorations. (Fugimoto et al., 2019) |
| Dual cured resin cement | Active comparator | Other: Dual cured resin cementDual cured resin cement is chosen as a comparator (gold standard )for the cementation of indirect restorations. (Sadighpour et al., 2018) Resin cement is insoluble and has superior mechanical and physical properties, compared with other previous luting materials. The clinical advantages of resin cement include high resistance to compression forces, low thermal expansion coefficients, high flexural strengths, and hardness. In addition, resin cement is characterized by adhesion to many materials, the ability to modify shade and color, high retention, resistance to wear at the margin of the restoration, and low marginal permeability. Resin cement provides optimal bond with resin composite indirect restorations and evenly distributes the compression force along all contact surfaces. (Gurdal et al., 2018 |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with vital, asymptomatic, badly broken-down lower molar exhibiting at least two missing walls and one or more weakened or absent cusps (indicated for an onlay restoration), classified as ICDAS score (5)
- Patients with at least 20 teeth under occlusion.
- Age: 20-40 years.
- Males or females.
- Co-operative patients approving to participate in the trial.
Key exclusion criteria (11 listed)
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis or periapical pathosis
- Teeth supporting removable prostheses, or orthodontic appliances.
- Candidates with parafunction or bruxism or temporomandibular joint disorders
- Candidates with systemic diseases or disabilities that may affect participation.
- Heavy smoking.
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 |
|---|---|---|
| Injectable restorative resin compositeThe introduction of injectable composites, according to available literature, offers a simple and efficient solution for the cementation of veneers. This versatile, injectable restorative composite unites easy handling, high physical properties and excellent aesthetics. Generally used as a restorative material, it can also be used for the cementation of veneers and some inlays/onlays, thus considered as good alternative to preheated composite. (Alajrash MM et al., 2020) | Other | Injectable restorative resin composite material used for cementation |
| Dual cured resin cementResin cements are widely used due to their strong adhesion, and compatibility with various restorative materials, including ceramics and zirconia. They bond to enamel and dentin through functional monomers such as MDP, and 4-META, forming a stable hybrid layer. Based on their bonding mechanism, resin cements are classified as adhesive or self-adhesive, while their polymerization method -chemical, light, or dual-cure-allows for versatility in clinical applications | Other | Dual cured resin cement |
Primary outcome
Clinical Performance
Time frame: 18 months change from baseline to 6, 12, and 18 months
Retention, marginal integrity, secondary caries, anatomic form, surface texture, proximal contact and postoperative hypersensitivity. All these outcomes are measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable ,charlie is not accepted
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 13 Apr 2025.
- Derived from this study: PubMed 40988059Ashraf H, El Tannir A, El Zohairy A, Kamal D. Clinical performance of indirect hybrid ceramic onlay restorations cemented with injectable resin composite versus dual-cure resin cement: an 18-month randomized clinical trial. BMC Oral Health. 2025 Sep 23;25(1):1419. doi: 10.1186/s12903-025-06903-5.
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Enrolling by invitation
Comparison of Post Cementation Sensitivity Between RMGIC and GIC as Luting Materials in a Randomized Clinical Trial
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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?
A study testing Injectable restorative resin composite and Dual cured resin cement in people with Cementation Teeth and Badly Broken Down Vital Teeth, run by Cairo University at 1 site in Egypt.
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 11 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 13 Apr 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 Egypt. 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?
Clinical Performance (time frame: 18 months change from baseline to 6, 12, and 18 months). 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 NCT05954156, which also lists 1 linked publication.
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 13 Apr 2025.