Caries Class IiNCT06833177
Clinical Evaluation of Ceramage Inlays Cemented With Beautilink Self-Adhesive Resin Cement Versus Rely X Resin Cement in Carious Posterior Teeth
A study testing Beautilink SA cement and RelyX resin cement in people with Caries Class Ii, run by Cairo University at 1 site in Egypt.
Trial summary
Minimally invasive bonded partial restorations have become a crucial component of contemporary dental treatments. They address the shortcomings of direct restorations and provide patients with a less damaging alternative to full coverage restorations, which can be more harmful to the dental structure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caries Class Ii
- What is being tested?
- Beautilink SA cement and RelyX resin cement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2025to 20 Aug 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Posterior vital tooth with a large carious lesion (ICDAS 4/5)
- Posterior vital tooth with a broken restoration that should be replaced (ICDAS 4-7/5-7).
- Vital, periodontally sound and with positive reaction to cold stimulus.
- Fully erupted posterior molar in normal functional occlusion with natural antagonist and adjacent teeth.
Who cannot join
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth, Fractured or cracked teeth.
- Endodontically treated teeth.
- Periodontally affected teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eighteen Months Clinical Evaluation of Hybrid Ceramic Inlays Cemented With Giomer Based Self-adhesive Resin Cement Versus Resin-based Cement in Carious Posterior Teeth: Randomized Controlled Clinical Trial
Minimally invasive bonded partial restorations have become a crucial component of contemporary dental treatments. They address the shortcomings of direct restorations and provide patients with a less damaging alternative to full coverage restorations, which can be more harmful to the dental structure. Indirect inlay composite restorations have become a popular choice in restorative dentistry due to their aesthetic appeal and durability. These restorations allow for the preservation of tooth structure while utilizing the mechanical advantages of modern adhesive technology, which can reinforce the weakened compromised tooth structure.
The use of different adhesive materials with Ceramage can significantly influence the success of the restoration. Adhesive materials play a crucial role in ensuring a strong bond between the indirect restoration and the tooth structure. Additionally, the choice of adhesive material can also affect the ease of the cementation process. Self-adhesive resin cement simplifies the procedure by eliminating the need for separate bonding agents, thus reducing the risk of technique sensitivity which can lead to more consistent clinical outcomes and improved patient satisfaction.
Overall, the combination of Ceramage with appropriate adhesive materials offers a reliable and aesthetically pleasing solution for indirect inlay composite restorations, enhancing both the biological, functional and esthetic outcomes of dental treatments.
- Conditions
- Caries Class Ii
- Being tested
- Beautilink SA cement, RelyX resin cement
- Keywords
- Inlays, Ceramage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beautilink SA cementOther
According to the manufacturer's instructions (BeautiLink SA - Shofu USA)
- To enhance the adhesion, adhesive bonding agent BeautiBond Xtreme, Shofu will be applied on the tooth and cured according to the manufacturer's instructions.
- Press the plunger of the auto-mix syringe of Beautilink SA to dispence the cement on the adhesive surface of the restoration.
- Seat the restoration in the cavity and apply proper pressure after using Teflon to protect the adjacent teeth and help in the removal of the excess material.
- Light-cure the excess material for 1-2 sec with a light-curing unit followed by removal of the tack-cured material with a probe.
- Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 5 minutes after light-curing to allow for chemical curing.
RelyX resin cementOther
According to the manufacturer's instructions (Espe).
- To enhance the adhesion, adhesive bonding agent 3M™ Scotchbond™ Universal Plus Adhesive will be applied on the tooth and cured according to the manufacturer's instructions.
- Application of 3M™RelyX™ Universal Resin Cement into the cavity
- Seat the restoration in the cavity and apply proper pressure after using Teflon to protect the adjacent teeth and help in the removal of the excess material.
- Light-cure the excess material for 2-3 sec with a light-curing unit followed by removal of the tack-cured material with a probe.
- Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 6 minutes after light-curing to allow for chemical curing.
| Study group | Role | What they receive |
|---|---|---|
| Cementation via Beautilink SA cement | Experimental | Ceramage inlays will be cemented using Beautilink SA cement
* To enhance the adhesion, adhesive bonding agent BeautiBond Xtreme, Shofu will be applied on the tooth and cured according to the manufacturer's instructions.
* Press the plunger of the auto-mix syringe of Beautilink SA to dispence the cement on the adhesive surface of the restoration.
* Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 5 minutes after light-curing to allow for chemical curing. Receives: Other: Beautilink SA cement |
| Cementation via RelyX resin cement | Active comparator | Ceramage inlays will be cemented using RelyX resin cement
* To enhance the adhesion, adhesive bonding agent 3M™ Scotchbond™ Universal Plus Adhesive will be applied on the tooth and cured according to the manufacturer's instructions.
* Application of 3M™RelyX™ Universal Resin Cement into the cavity
* Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 6 minutes after light-curing to allow for chemical curing. Receives: Other: RelyX resin cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria
Alpha being the best results and Charlie being the worst results
Measured: T0: 12 months T1: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start11 Nov 2025
- Primary completion11 May 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries Class IiStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohamed Ahmed Gomaa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833177
- Sponsor's protocol ID
- 20091993
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eighteen Months Clinical Evaluation of Hybrid Ceramic Inlays Cemented With Giomer Based Self-adhesive Resin Cement Versus Resin-based Cement in Carious Posterior Teeth: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06833177
- Acronym / sponsor ID
- 20091993
- Conditions
- Caries Class Ii
- Keywords
- Inlays, Ceramage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 11 May 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 18 Feb 2025 (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.
Minimally invasive bonded partial restorations have become a crucial component of contemporary dental treatments. They address the shortcomings of direct restorations and provide patients with a less damaging alternative to full coverage restorations, which can be more harmful to the dental structure. Indirect inlay composite restorations have become a popular choice in restorative dentistry due to their aesthetic appeal and durability. These restorations allow for the preservation of tooth structure while utilizing the mechanical advantages of modern adhesive technology, which can reinforce the weakened compromised tooth structure.
The use of different adhesive materials with Ceramage can significantly influence the success of the restoration. Adhesive materials play a crucial role in ensuring a strong bond between the indirect restoration and the tooth structure. Additionally, the choice of adhesive material can also affect the ease of the cementation process. Self-adhesive resin cement simplifies the procedure by eliminating the need for separate bonding agents, thus reducing the risk of technique sensitivity which can lead to more consistent clinical outcomes and improved patient satisfaction.
Overall, the combination of Ceramage with appropriate adhesive materials offers a reliable and aesthetically pleasing solution for indirect inlay composite restorations, enhancing both the biological, functional and esthetic outcomes of dental treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cementation via Beautilink SA cement | Experimental | Other: Beautilink SA cementCeramage inlays will be cemented using Beautilink SA cement * To enhance the adhesion, adhesive bonding agent BeautiBond Xtreme, Shofu will be applied on the tooth and cured according to the manufacturer's instructions. * Press the plunger of the auto-mix syringe of Beautilink SA to dispence the cement on the adhesive surface of the restoration. * Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 5 minutes after light-curing to allow for chemical curing. |
| Cementation via RelyX resin cement | Active comparator | Other: RelyX resin cementCeramage inlays will be cemented using RelyX resin cement * To enhance the adhesion, adhesive bonding agent 3M™ Scotchbond™ Universal Plus Adhesive will be applied on the tooth and cured according to the manufacturer's instructions. * Application of 3M™RelyX™ Universal Resin Cement into the cavity * Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 6 minutes after light-curing to allow for chemical curing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Posterior vital tooth with a large carious lesion (ICDAS 4/5)
- Posterior vital tooth with a broken restoration that should be replaced (ICDAS 4-7/5-7).
- Vital, periodontally sound and with positive reaction to cold stimulus.
- Fully erupted posterior molar in normal functional occlusion with natural antagonist and adjacent teeth.
Key exclusion criteria (4 listed)
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth, Fractured or cracked teeth.
- Endodontically treated teeth.
- Periodontally affected teeth.
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 |
|---|---|---|
| Beautilink SA cementAccording to the manufacturer's instructions (BeautiLink SA - Shofu USA) * To enhance the adhesion, adhesive bonding agent BeautiBond Xtreme, Shofu will be applied on the tooth and cured according to the manufacturer's instructions. * Press the plunger of the auto-mix syringe of Beautilink SA to dispence the cement on the adhesive surface of the restoration. * Seat the restoration in the cavity and apply proper pressure after using Teflon to protect the adjacent teeth and help in the removal of the excess material. * Light-cure the excess material for 1-2 sec with a light-curing unit followed by removal of the tack-cured material with a probe. * Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 5 minutes after light-curing to allow for chemical curing. | Other | Cementation via Beautilink SA cement |
| RelyX resin cementAccording to the manufacturer's instructions (Espe). * To enhance the adhesion, adhesive bonding agent 3M™ Scotchbond™ Universal Plus Adhesive will be applied on the tooth and cured according to the manufacturer's instructions. * Application of 3M™RelyX™ Universal Resin Cement into the cavity * Seat the restoration in the cavity and apply proper pressure after using Teflon to protect the adjacent teeth and help in the removal of the excess material. * Light-cure the excess material for 2-3 sec with a light-curing unit followed by removal of the tack-cured material with a probe. * Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 6 minutes after light-curing to allow for chemical curing. | Other | Cementation via RelyX resin cement |
Primary outcome
Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria
Time frame: T0: 12 months T1: 18 months
Alpha being the best results and Charlie being the worst results
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 7 Apr 2026.
- 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?
A study testing Beautilink SA cement and RelyX resin cement in people with Caries Class Ii, 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. 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?
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?
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 assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria (time frame: T0: 12 months T1: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.