Dental CariesNCT02991573
Clinical Study Class II on Ceram.x Universal and Prime&Bond
A study testing Prime & Bond Universal, Ceram X and Prime & Bond XP in people with Dental Caries, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Damage to teeth from decay or previous old silver fillings can be repaired with tooth-coloured filling materials that stick to the tooth. These materials have been around for some years and have become more sophisticated; with greater ease of placement by the dentist and better durability for the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries
- What is being tested?
- Prime & Bond Universal, Ceram X and Prime & Bond XP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to 31 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either gender and at least 18 years old at the start of the study (enrollment), who are seeking treatment at the dental clinic involved, will be invited to participate in the study if they are in need of at least one eligible Class II posterior restoration in a permanent molar.
- Tooth inclusion criteria:
- Per patient, a maximum of three Class II restorations will be included. If three restorations are indicated and eligible, one of each material will be included.
- Vital, non-symptomatic permanent teeth with Class II lesions are suitable for inclusion into the study if the following criteria are met:
- - location: first or second molars (ADA guidelines[1]);
- - restoration size: moderate: no cusp replacements;
Show all 11Show fewer
- - cavity size: occlusal width ≥ 1/3 of intercuspal distance (ADA guidelines[1]);
- - cavity outline: preparation to include a proximal box with or without an occlusal step;
- - box: cervical outline in enamel;
- - occlusion: at least one opposing contact point in enamel.
- Enrollment of patients will continue until the specified minimum number of restorations per group (N=25) and/or the minimum number of patients (N=50) have been reached.
Who cannot join
- The exclusion criteria (i.e. contraindications) as described in the Instructions for Use of the test, control and restorative materials apply:
- Use with patients who have a history of severe allergic reaction methacrylate resins or any of the components; direct application to dental pulp (direct pulp capping).
- Patients who are unable to give informed consent or vulnerable population as defined in ISO 14155[4] will not be enrolled.
- Tooth exclusion criteria:
- As a rule, the materials are not to be used in situations as specified in the Instructions for Use - Section Contraindications.
- direct or indirect pulp-capping Furthermore, teeth with class II lesions are excluded when involved with
Show all 10Show fewer
- inflammation or pulpitis (pain),
- periodontitis with probing depth > 6 mm,
- extraction of tooth to be expected within the next 12 months,
- signs of strong parafunctions or erosion (exposed dentin on occlusal surface and/or wear facets > 6 mm2)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Professor Nicolas Martin
Sheffield, South Yorkshire, S10 2TA
About this study
Official title: Clinical Post-Market Surveillance Study of Ceram.x Universal and Prime&Bond Universal When Used for Class II Restorations at the University of Sheffield
Damage to teeth from decay or previous old silver fillings can be repaired with tooth-coloured filling materials that stick to the tooth. These materials have been around for some years and have become more sophisticated; with greater ease of placement by the dentist and better durability for the patient. The fillings are designed to be used in combination with a specific glue (adhesive) that is designed to stick to the different parts of the tooth to provide a good seal, the outer enamel and the inner dentine.
This study will examine the performance of a state-of-the-art modern tooth coloured filling material (Ceram X) in combination with an existing adhesive (control adhesive) and a new adhesive (Prime \& Bond Universal) used in two different techniques; both of which are known to work but one is easier to apply. This results in three treatment groups.
Read more
At the start of the study, the test material Prime\&Bond Universal is CE-marked, as are all other medical devices used. Thus, this study is not conducted to meet any regulatory requirements. The rationale of this study is the extension of knowledge primarily concerning the clinical performance of Prime\&Bond Universal in molars.
Two investigators (to be confirmed) will place a minimum of 25 restorations per group (75 restorations in total) to assess the performance of the materials in a comparative design. The study restorations will be monitored for a period of 18 months (with the option to extend the evaluation period to 48 months).
After placement of restorations under controlled clinical conditions, the primary objective of the study is the determination of post-operative sensitivity and pulp vitality, marginal adaptation and staining of margins of the restorations. In addition, fracture of material and retention, recurrent caries, occlusal contour and wear, approximal anatomical form will be determined as well as the failure rate as defined by the ADA.
- Conditions
- Dental Caries
- Being tested
- Prime & Bond Universal, Ceram X, Prime & Bond XP, technique 1, technique 2
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prime & Bond UniversalDevice
Prime \& Bond Universal
Ceram XDevice
Prime & Bond XPDevice
Control
technique 1Procedure or surgery
technique 2Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| existing adhesive (control) | Active comparator | control adhesive Receives: Device: Ceram X; Device: Prime & Bond XP |
| new adhesive: technique 1 | Experimental | Prime \& Bond Universal: technique 1 Receives: Device: Prime & Bond Universal; Device: Ceram X; Procedure: technique 1 |
| new adhesive: technique 2 | Experimental | Prime \& Bond Universal: technique 2 Receives: Device: Prime & Bond Universal; Device: Ceram X; Procedure: technique 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related postoperative sensitivity recorded as a change from baseline to that reported at 14 days, 6 months, 12 months and 48 months, assessed using a visual analog scale.
Measured: 14 days, 6 months, 12 months and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startNov 2015
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply International
- Responsible party
- Sponsor
- Investigators
- Nicolas Martin, Professor, Principal investigator, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991573
- Sponsor's protocol ID
- STH18842 CIP 14.1515
- Status last verified
- Sep 2019
- First submitted
- 4 Dec 2015
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Post-Market Surveillance Study of Ceram.x Universal and Prime&Bond Universal When Used for Class II Restorations at the University of Sheffield
- ClinicalTrials.gov ID
- NCT02991573
- Acronym / sponsor ID
- STH18842 CIP 14.1515
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Dentsply International
- Study start
- Nov 2015 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
Damage to teeth from decay or previous old silver fillings can be repaired with tooth-coloured filling materials that stick to the tooth. These materials have been around for some years and have become more sophisticated; with greater ease of placement by the dentist and better durability for the patient. The fillings are designed to be used in combination with a specific glue (adhesive) that is designed to stick to the different parts of the tooth to provide a good seal, the outer enamel and the inner dentine.
This study will examine the performance of a state-of-the-art modern tooth coloured filling material (Ceram X) in combination with an existing adhesive (control adhesive) and a new adhesive (Prime \& Bond Universal) used in two different techniques; both of which are known to work but one is easier to apply. This results in three treatment groups.
At the start of the study, the test material Prime\&Bond Universal is CE-marked, as are all other medical devices used. Thus, this study is not conducted to meet any regulatory requirements. The rationale of this study is the extension of knowledge primarily concerning the clinical performance of Prime\&Bond Universal in molars.
Two investigators (to be confirmed) will place a minimum of 25 restorations per group (75 restorations in total) to assess the performance of the materials in a comparative design. The study restorations will be monitored for a period of 18 months (with the option to extend the evaluation period to 48 months).
After placement of restorations under controlled clinical conditions, the primary objective of the study is the determination of post-operative sensitivity and pulp vitality, marginal adaptation and staining of margins of the restorations. In addition, fracture of material and retention, recurrent caries, occlusal contour and wear, approximal anatomical form will be determined as well as the failure rate as defined by the ADA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| existing adhesive (control) | Active comparator | Device: Ceram X, Device: Prime & Bond XPcontrol adhesive |
| new adhesive: technique 1 | Experimental | Device: Prime & Bond Universal, Device: Ceram X, Procedure: technique 1Prime \& Bond Universal: technique 1 |
| new adhesive: technique 2 | Experimental | Device: Prime & Bond Universal, Device: Ceram X, Procedure: technique 2Prime \& Bond Universal: technique 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients of either gender and at least 18 years old at the start of the study (enrollment), who are seeking treatment at the dental clinic involved, will be invited to participate in the study if they are in need of at least one eligible Class II posterior restoration in a permanent molar.
- Per patient, a maximum of three Class II restorations will be included. If three restorations are indicated and eligible, one of each material will be included.
- Vital, non-symptomatic permanent teeth with Class II lesions are suitable for inclusion into the study if the following criteria are met:
- Enrollment of patients will continue until the specified minimum number of restorations per group (N=25) and/or the minimum number of patients (N=50) have been reached.
Key exclusion criteria (10 listed)
- The exclusion criteria (i.e. contraindications) as described in the Instructions for Use of the test, control and restorative materials apply:
- Use with patients who have a history of severe allergic reaction methacrylate resins or any of the components; direct application to dental pulp (direct pulp capping).
- Patients who are unable to give informed consent or vulnerable population as defined in ISO 14155[4] will not be enrolled.
- As a rule, the materials are not to be used in situations as specified in the Instructions for Use - Section Contraindications.
- direct or indirect pulp-capping Furthermore, teeth with class II lesions are excluded when involved with
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 |
|---|---|---|
| Prime & Bond UniversalPrime \& Bond Universal | Device | new adhesive: technique 1, new adhesive: technique 2 |
| Ceram X | Device | existing adhesive (control), new adhesive: technique 1, new adhesive: technique 2 |
| Prime & Bond XPControl | Device | existing adhesive (control) |
| technique 1 | Procedure or surgery | new adhesive: technique 1 |
| technique 2 | Procedure or surgery | new adhesive: technique 2 |
Primary outcome
Number of participants with treatment-related postoperative sensitivity recorded as a change from baseline to that reported at 14 days, 6 months, 12 months and 48 months, assessed using a visual analog scale.
Time frame: 14 days, 6 months, 12 months and 48 months
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 15 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
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.
Nicolas Martin, Professor principal investigator
Sheffield Teaching Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prime & Bond Universal, Ceram X and Prime & Bond XP in people with Dental Caries, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 11 inclusion and 10 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 15 Nov 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 United Kingdom. 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?
Number of participants with treatment-related postoperative sensitivity recorded as a change from baseline to that reported at 14 days, 6 months, 12 months and 48 months, assessed using a visual analog scale. (time frame: 14 days, 6 months, 12 months and 48 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 15 Nov 2023.