Dental Restoration FailuresNCT05551481
Follow-up of Indirect Restorations Luted With Different Adhesive Resin Cement
A study testing To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years. in people with Dental Restoration Failures, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years. Methods: From February 2017 to May 2017, a total of 43 patients (21 men, 22 women; mean age.), received 48 onlay restorations made of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failures
- What is being tested?
- To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2017to 10 Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria Patients in need of removal of old large amalgam restorations or having extensive caries lesions were recruited for the study.
Adults of at least 18 years of age, with good oral hygiene, having an antagonist tooth in occlusion, being mentally in a good state to provide written consent to participate in the clinical study, and willing to attend the scheduled follow-up appointments.
Exclusion criteria Exclusion criteria included the presence of teeth with severe periodontal problems, high caries risk, and bruxism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2 Year Follow-up of Indirect Resin Composite Restorations Luted With Different Adhesive Resin Cement: A Randomized Clinical Trial
Objective: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.
Methods: From February 2017 to May 2017, a total of 43 patients (21 men, 22 women; mean age.), received 48 onlay restorations made of laboratory-processed indirect composite (Gradia, GC, Japan). 27 onlay restorations (Group A) were luted using an etch and rinse resin cement (Variolink II, Ivoclar Vivadent) and 22 onlay restorations (Group B) were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE). Patients were followed until May 2019. Two independent calibrated examiners evaluated the restorations at 3-time points: 2 weeks after placement (baseline), 6 months, and then annually, using the modified USPHS/FDI criteria.
Read the detailed description
Study design The ethical committee of Istanbul Medipol University approved this clinical study. Patients were given written informed consent to participate before treatment and agreed to a recall program at baseline 2 weeks, 6 months, and thereafter annually. All restorative procedures were carried out by one experienced dentist from the Department of Restorative Dentistry at Istanbul Medipol University.
Inclusion and exclusion criteria
Patients in need of removal of old large amalgam restorations or having extensive caries lesions were recruited for the study. Inclusion and exclusion criteria were as follows:
Adults of at least 18 years of age, with good oral hygiene, having an antagonist tooth in occlusion, being mentally in a good state to provide written consent to participate in the clinical study, and willing to attend the scheduled follow-up appointments. Exclusion criteria included the presence of teeth with severe periodontal problems, high caries risk, and bruxism.
Cavities were prepared according to common principles, which included an occlusal reduction of 1.5-2 mm with a wide isthmus and rounded occlusal-axial angles, and an axial wall of 1.5 mm in thickness. Where possible, the gingival margins were prepared entirely in enamel at the cemento-enamel junction, and cavities for overlays included both buccal and lingual/palatal cusps. Both cavity types (onlays and overlays) were prepared with rounded internal angles, with a divergence of 6-15° between the walls and margins with a 90° cave surface.
Full-arch impressions were made with a single impression/double mixing technique using polyether material (Impregum Penta H Duoso, 3M ESPE, Minn, USA) cavity preparations were provisionalized for 1 week with photo-polymerized provisional material (Clip, Voco, Cuxhaven, Germany). All onlays were definitively inserted within 1 week after impression. After the removal of provisional restorations, the teeth were thoroughly cleaned with a prophylaxis brush and pumice.
After adjustment when needed, the restorations were luted adhesively under a rubber dam, employing a total-etch system in group A. The prepared teeth were initially cleaned with pumice slurry and etched with 35% phosphoric acid gel (Ultra-etch, Ultradent, South Jordan, UT, USA). The dentin adhesive system (Syntac Classic, Ivoclar Vivadent, Liechtenstein) was then applied uniform and gently air thinned. The internal surface of the restorations was silanized (Monobond S, Ivoclar Vivadent), waited for its reaction for 60 s and the solvent was evaporated with oil-free compressed air. The onlays and overlays were luted adhesively with etch and rinse, dual cure resin cement (Variolink II, Ivoclar Vivadent). In Group B were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE).
Excess resin cement was removed in all cases with an explorer, a brush, and dental floss interproximally. Each only surface was light-cured for 40 s with a polymerization light (Elipar Highlight, 3M Espe, Seefeld, Germany). After placement and removal of the rubber dam, static and dynamic occlusion was adjusted using fine grit diamond burs, then inlays were finished with disks and strips (Sof-Lex, 3M Dental Products, St. Paul, MN, USA).
- Conditions
- Dental Restoration Failures
- Being tested
- To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.
- Keywords
- indirect composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.Procedure or surgery
Also called restorations made of laboratory-processed- luted using an etch and rinse resin cement (Variolink II, Ivoclar Vivadent) and 22 onlay restorations (Group B) were luted using a self-
resin cement (Variolink II, Ivoclar Vivadent)-self-adhesive resin cement (Relyx U200, 3M ESPE)
| Study group | Role | What they receive |
|---|---|---|
| In Group A,(Variolink II, Ivoclar Vivadent). | Experimental | In Group A, the onlays and overlays were luted adhesively with etch and rinse, dual cure resin cement (Variolink II, Ivoclar Vivadent). Receives: Procedure: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years. |
| In Group B, (Relyx U200, 3M ESPE). | Active comparator | In Group B the onlays and overlays were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE). Receives: Procedure: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocrowns FDI evaluation
this clinical trial aimed to evaluate posterior teeth restored with indirect resin composites and compare clinical performances of two resin cement (one etch and rinse and one self-adhesive) 2 weeks and 6, 12, 24 months, and 5 years after the luting of indirect resin composite restorations using the modified USPHS/FDI criteria.
Measured: 2 year
Secondary outcomes (1)
Aesthetic :Functional :Biological :Vitality-resin cement
Surface luster-Surface staining-Colour stability and translucency-Anatomic form.Fracture and retention-Marginal adaptation-Wear -Proximal contact-Patient's viewFracture and retention-Marginal adaptation-Wear -Proximal contact-Patient's view.Postoperative hypersensitivity-Recurrent of caries, erosion, abfraction-Tooth integrity-Vitality-resin cement
Measured: 2 weeks and 6, 12 months and 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start10 Feb 2017
- Primary completion10 May 2019
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration FailuresStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yeldaerdem, Istanbul Medipol University Hospital
- Investigators
- yelda erdem hepsenoglu, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551481
- Sponsor's protocol ID
- Indirect Resin Composite
- Status last verified
- Oct 2023
- First submitted
- 19 Aug 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2 Year Follow-up of Indirect Resin Composite Restorations Luted With Different Adhesive Resin Cement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05551481
- Acronym / sponsor ID
- Indirect Resin Composite
- Conditions
- Dental Restoration Failures
- Keywords
- indirect composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 22 Sep 2022 (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.
Objective: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.
Methods: From February 2017 to May 2017, a total of 43 patients (21 men, 22 women; mean age.), received 48 onlay restorations made of laboratory-processed indirect composite (Gradia, GC, Japan). 27 onlay restorations (Group A) were luted using an etch and rinse resin cement (Variolink II, Ivoclar Vivadent) and 22 onlay restorations (Group B) were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE). Patients were followed until May 2019. Two independent calibrated examiners evaluated the restorations at 3-time points: 2 weeks after placement (baseline), 6 months, and then annually, using the modified USPHS/FDI criteria.
Detailed description
Study design The ethical committee of Istanbul Medipol University approved this clinical study. Patients were given written informed consent to participate before treatment and agreed to a recall program at baseline 2 weeks, 6 months, and thereafter annually. All restorative procedures were carried out by one experienced dentist from the Department of Restorative Dentistry at Istanbul Medipol University.
Inclusion and exclusion criteria
Patients in need of removal of old large amalgam restorations or having extensive caries lesions were recruited for the study. Inclusion and exclusion criteria were as follows:
Adults of at least 18 years of age, with good oral hygiene, having an antagonist tooth in occlusion, being mentally in a good state to provide written consent to participate in the clinical study, and willing to attend the scheduled follow-up appointments. Exclusion criteria included the presence of teeth with severe periodontal problems, high caries risk, and bruxism.
Cavities were prepared according to common principles, which included an occlusal reduction of 1.5-2 mm with a wide isthmus and rounded occlusal-axial angles, and an axial wall of 1.5 mm in thickness. Where possible, the gingival margins were prepared entirely in enamel at the cemento-enamel junction, and cavities for overlays included both buccal and lingual/palatal cusps. Both cavity types (onlays and overlays) were prepared with rounded internal angles, with a divergence of 6-15° between the walls and margins with a 90° cave surface.
Full-arch impressions were made with a single impression/double mixing technique using polyether material (Impregum Penta H Duoso, 3M ESPE, Minn, USA) cavity preparations were provisionalized for 1 week with photo-polymerized provisional material (Clip, Voco, Cuxhaven, Germany). All onlays were definitively inserted within 1 week after impression. After the removal of provisional restorations, the teeth were thoroughly cleaned with a prophylaxis brush and pumice.
After adjustment when needed, the restorations were luted adhesively under a rubber dam, employing a total-etch system in group A. The prepared teeth were initially cleaned with pumice slurry and etched with 35% phosphoric acid gel (Ultra-etch, Ultradent, South Jordan, UT, USA). The dentin adhesive system (Syntac Classic, Ivoclar Vivadent, Liechtenstein) was then applied uniform and gently air thinned. The internal surface of the restorations was silanized (Monobond S, Ivoclar Vivadent), waited for its reaction for 60 s and the solvent was evaporated with oil-free compressed air. The onlays and overlays were luted adhesively with etch and rinse, dual cure resin cement (Variolink II, Ivoclar Vivadent). In Group B were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE).
Excess resin cement was removed in all cases with an explorer, a brush, and dental floss interproximally. Each only surface was light-cured for 40 s with a polymerization light (Elipar Highlight, 3M Espe, Seefeld, Germany). After placement and removal of the rubber dam, static and dynamic occlusion was adjusted using fine grit diamond burs, then inlays were finished with disks and strips (Sof-Lex, 3M Dental Products, St. Paul, MN, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In Group A,(Variolink II, Ivoclar Vivadent). | Experimental | Procedure: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.In Group A, the onlays and overlays were luted adhesively with etch and rinse, dual cure resin cement (Variolink II, Ivoclar Vivadent). |
| In Group B, (Relyx U200, 3M ESPE). | Active comparator | Procedure: To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.In Group B the onlays and overlays were luted using a self-adhesive resin cement (Relyx U200, 3M ESPE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years.Also: restorations made of laboratory-processed- luted using an etch and rinse resin cement (Variolink II, Ivoclar Vivadent) and 22 onlay restorations (Group B) were luted using a self-resin cement (Variolink II, Ivoclar Vivadent)-self-adhesive resin cement (Relyx U200, 3M ESPE) | Procedure or surgery | In Group A,(Variolink II, Ivoclar Vivadent)., In Group B, (Relyx U200, 3M ESPE). |
Primary outcome
Endocrowns FDI evaluation
Time frame: 2 year
this clinical trial aimed to evaluate posterior teeth restored with indirect resin composites and compare clinical performances of two resin cement (one etch and rinse and one self-adhesive) 2 weeks and 6, 12, 24 months, and 5 years after the luting of indirect resin composite restorations using the modified USPHS/FDI criteria.
1 secondary outcome
Aesthetic :Functional :Biological :Vitality-resin cement
Time frame: 2 weeks and 6, 12 months and 2 year
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 5 Oct 2023.
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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.
yelda erdem hepsenoglu study chair
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To evaluate the clinical performance of indirect resin composite restorations, which were luted with two different resin cement, in posterior teeth for up to 2 years. in people with Dental Restoration Failures, run by Istanbul Medipol University Hospital 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?
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 5 Oct 2023. 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?
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?
Endocrowns FDI evaluation (time frame: 2 year). 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 5 Oct 2023.