Cavities of TeethNCT05248204

Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal

A study testing Scotchbond™ Universal Plus Adhesive and Scotchbond™ Universal Adhesive in people with Cavities of Teeth and Dental Decay, run by Solventum US LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Cavities of Teeth, Dental Decay
What is being tested?: Scotchbond™ Universal Plus Adhesive and Scotchbond™ Universal Adhesive
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 14 Jun 2022to 6 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The Subject is between the ages of 18 and 70 years old at time of consent.
The Subject requires at least two direct composite restorations for posterior Class I or Class II carious lesions in vital teeth that are asymptomatic and with minimal mobility (< 1 mm in the buccolingual direction).
Study teeth have a minimum buccolingual diameter of the occlusal surface that is at least 1/3 of the distance between the buccal and lingual cusps
Teeth selected for Class II restorations need to have an adjacent tooth in a position that will allow for a contact relationship to be established.
The Subject is able and willing to sign Informed Consent Form in English without assistance.
The Subject is able and willing to be available for all scheduled study visits.

Show all 9Show fewer

The Subject is in good general health (ie, meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria).
The selected teeth need to have occlusal contact with an antagonistic natural tooth.
The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months.

Who cannot join

The Subject has a history of adverse reaction to any materials used in this study.
The Subject is pregnant or breast feeding at the time of screening.
The Subject has fewer than 20 teeth.
The Subject is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study.
The Subject has advanced periodontal disease (ie, Grace \& Smales Mobility Index grade ≥ 2) that involve the study teeth.
The Subject had orthodontic appliance treatment within the previous 3 months.

Show all 16Show fewer

The Subject has pronounced enamel wear facets, indicating severe, on-going bruxism.
The Subject has severe xerostomia.
The study tooth has a history of or existing, prolonged tooth hypersensitivity.
The study tooth is an abutment for fixed or removable prostheses.
The study tooth has a fracture or is visibly cracked such that it may impact the longevity of the tooth.
The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring system.
The Subject is unable to understand study procedures or provide consent in English.
The Subject is an employee or student of the study investigator(s).
Intraoperative Exclusion Criteria:
1) The Subject has pulp exposure of either study tooth during the restoration procedure.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota School of Dentristry
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Prospective, Randomized, Split-mouth Study Evaluating Clinical Performance of 3M™ Scotchbond™ Universal Plus Adhesive Compared to 3M Scotchbond Universal Adhesive for Posterior Class I & II Restorations With 3M Filtek™ Universal Restorative

This research study is looking at a new bond-promoting substance (a dental adhesive called 3M™ Scotchbond™ Universal Plus Adhesive) used between the tooth and dental restoration (filling). This is a randomized, split-mouth study designed to evaluate whether Scotchbond™ Universal Plus Adhesive (SBU+) is as effective at bonding dental fillings as Scotchbond™ Universal Adhesive (SBU) for preparation of posterior Class I and Class II restorations in adult patients. Participants must have at least two (2) back teeth that need a filling either on the chewing surface alone (Class I) and/or on the chewing surface and between your teeth (Class II). One tooth will be restored using SBU+ and the other tooth will be restored using SBU adhesive, both filled using Filtek™ Universal Restorative as the filling material.

Read the detailed description

This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study. The study is designed to compare the clinical efficacy of Scotchbond™ Universal Plus Adhesive with Scotchbond™ Universal Adhesive when used in self-etch mode for preparation of posterior Class I and Class II restorations using Filtek™ Universal Restorative material in adult patients.

Selected endpoints are based partly on the FDI World Dental Federation criteria. Subjects who meet all inclusion and none of the exclusion criteria and who have provided informed consent will be eligible for enrollment and must be treated within 21 days of screening. Either two pre-molars or two molars from each Subject will be randomized in a 1:1 ratio such that one of the teeth will be randomized to undergo restoration using SBU+ Adhesive (Treatment), and the other tooth will undergo restoration using SBU Adhesive (Control). Both study teeth will be restored using Filtek™ Universal Restorative material as the filling material. Individual subject participation is expected to last 2 years (± 45 days) with scheduled study visits at screening, day of restoration/baseline, and follow-up visits at 6 months (± 14 days), 1 year (± 30 days), and 2 years (± 45 days) after restoration. The entire duration of the study is expected to last approximately 3 years, with individual Subject participation expected to last up to 2 years (± 45 days).

To help minimize or avoid bias in the study, randomization of study teeth will occur after teeth preparation but before the initial application of any adhesive. All assessments will be performed by two dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms. All examiners will be trained and calibrated for the scoring criteria before any Subject assessment occurs, and examiners will be retrained and recalibrated if any new evaluator is added to the list of assessors. After the second examiner has completed their assessments, then the examiners will compare their evaluations and a consensus will be reached for each of the scoring criteria at each visit. A consensus will be reached before the Subject leaves the visit, and the consensus assessments will be entered into the Case Report Form (CRF).

Conditions: Cavities of Teeth, Dental Decay
Being tested: Scotchbond™ Universal Plus Adhesive, Scotchbond™ Universal Adhesive
Keywords: dental materials, dental adhesives, dental fillings, dental cavities, Scotchbond Universal Plus, Scotchbond Universal, Filtek Universal Restorative
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Scotchbond™ Universal Plus AdhesiveDevice
Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative
Scotchbond™ Universal AdhesiveDevice
Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative

Study groups in NCT05248204
Study group	Role	What they receive
Scotchbond Universal Plus Treatment	Experimental	Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Receives: Device: Scotchbond™ Universal Plus Adhesive
Scotchbond Universal Comparator	Active comparator	Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Receives: Device: Scotchbond™ Universal Adhesive

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration materials
Measured: 24 months post-restoration
Fracture of Restorative Material
Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria.
Measured: 24 months post-restoration
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.
Measured: 24 months post-restoration

Secondary outcomes (7)

Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration materials
Measured: 6 months post-restoration
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration materials
Measured: 12 months post-restoration
Fracture of Restorative Material
Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria.
Measured: 6 months post-restoration
Fracture of Restorative Material
Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria.
Measured: 12 months post-restoration
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.
Measured: baseline day of restoration
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.
Measured: 6 months post-restoration
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.
Measured: 12 months post-restoration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 20226 Mar 2025

First posted21 Feb 2022
Study start14 Jun 2022
Primary completion6 Mar 2025
Study completion6 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cavities of TeethStudies 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: This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05248204
Sponsor's protocol ID: EM-11-050069
Status last verified: Oct 2025
First submitted: 10 Feb 2022
Last updated: 17 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PubMed 20628774
Perdigao J, Dutra-Correa M, Anauate-Netto C, Castilhos N, Carmo AR, Lewgoy HR, Amore R, Cordeiro HJ. Two-year clinical evaluation of self-etching adhesives in posterior restorations. J Adhes Dent. 2009 Apr;11(2):149-59.
PubMed 19492717

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)

All Cavities of Teeth trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Split-mouth Study Evaluating Clinical Performance of 3M™ Scotchbond™ Universal Plus Adhesive Compared to 3M Scotchbond Universal Adhesive for Posterior Class I & II Restorations With 3M Filtek™ Universal Restorative
ClinicalTrials.gov ID: NCT05248204
Acronym / sponsor ID: EM-11-050069
Conditions: Cavities of Teeth, Dental Decay
Keywords: dental materials, dental adhesives, dental fillings, dental cavities, Scotchbond Universal Plus, Scotchbond Universal, Filtek Universal Restorative
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Study start: 14 Jun 2022 (actual)
Primary completion: 6 Mar 2025 (actual)
Study completion: 6 Mar 2025 (actual)
First posted: 21 Feb 2022 (actual)
Results: Posted 17 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study.

Arm	Type	Receives
Scotchbond Universal Plus Treatment	Experimental	Device: Scotchbond™ Universal Plus AdhesiveStudy tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).
Scotchbond Universal Comparator	Active comparator	Device: Scotchbond™ Universal AdhesiveStudy tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

The Subject is between the ages of 18 and 70 years old at time of consent.
The Subject requires at least two direct composite restorations for posterior Class I or Class II carious lesions in vital teeth that are asymptomatic and with minimal mobility (< 1 mm in the buccolingual direction).
Study teeth have a minimum buccolingual diameter of the occlusal surface that is at least 1/3 of the distance between the buccal and lingual cusps
Teeth selected for Class II restorations need to have an adjacent tooth in a position that will allow for a contact relationship to be established.
The Subject is able and willing to sign Informed Consent Form in English without assistance.

Key exclusion criteria (16 listed)

The Subject has a history of adverse reaction to any materials used in this study.
The Subject is pregnant or breast feeding at the time of screening.
The Subject has fewer than 20 teeth.
The Subject is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study.
The Subject has advanced periodontal disease (ie, Grace \& Smales Mobility Index grade ≥ 2) that involve the study 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
Scotchbond™ Universal Plus AdhesiveEligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Device	Scotchbond Universal Plus Treatment
Scotchbond™ Universal AdhesiveEligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative	Device	Scotchbond Universal Comparator

Primary outcome

Retention of Restorative Material
Time frame: 24 months post-restoration
The percentage of restorations with partial or complete loss of the restoration materials
Fracture of Restorative Material
Time frame: 24 months post-restoration
Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria.
Marginal Adaptation
Time frame: 24 months post-restoration
Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.

7 secondary outcomes

Retention of Restorative Material
Time frame: 6 months post-restoration
Retention of Restorative Material
Time frame: 12 months post-restoration
Fracture of Restorative Material
Time frame: 6 months post-restoration
Fracture of Restorative Material
Time frame: 12 months post-restoration
Marginal Adaptation
Time frame: baseline day of restoration
Marginal Adaptation
Time frame: 6 months post-restoration
Marginal Adaptation
Time frame: 12 months post-restoration

Results and safety

Results posted to the registry on 17 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Scotchbond Universal Plus Treatment	51	37
Scotchbond Universal Comparator	51	38

Primary outcome: Retention of Restorative Material

Time frame: 24 months post-restoration. Number. Unit: percentage of restorations

Measure	Scotchbond Universal Plus Treatment n = 38	Scotchbond Universal Comparator n = 38
No loss of restorative material	97	100
Partial or complete loss of restorative material	3	0

Population analysed: 38 subjects completed the study; 1 subject in the treatment group had 1 tooth withdrawn prior to 24 months

Primary outcome: Fracture of Restorative Material

Time frame: 24 months post-restoration. Number. Unit: percentage of restorations

Measure	Scotchbond Universal Plus Treatment n = 38	Scotchbond Universal Comparator n = 38
1. Excellent/Very Good	97	100
2. Good	0	0
3. Sufficient/Satisfactory	3	0
4. Unsatisfactory	0	0

Population analysed: 38 subjects completed the study; 1 subject had 1 tooth withdrawn prior to 24 months Scoring categories for the fracture of restorative material are defined as follows: 1. Excellent/very good: No fractures/cracks 2. Good: Small hairline cracks 3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact 4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts

Primary outcome: Marginal Adaptation

Time frame: 24 months post-restoration. Number. Unit: percentage of restorations

Measure	Scotchbond Universal Plus Treatment n = 38	Scotchbond Universal Comparator n = 38
1. Excellent/Very Good	8	4
2. Good	92	94
3. Sufficient/Satisfactory	0	2
4. Unsatisfactory	0	0
5. Poor	0	0

Population analysed: Scoring categories for marginal adaptation are defined as follows: 1. Excellent/very good: No clinically detectable gap. 2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing. 3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area. 4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base. 5. Poor: Generalized major gap or irregularities; or the restoration is loose but in situ.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All device-related and serious adverse events were collected from the time of restoration through the 24-month follow-up visit. Non-serious, non-device related adverse events were collected from the time of restoration through the 6-month follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Scotchbond Universal Plus Treatment	0 of 51 (0%)	8 of 51 (15.7%)	0 of 51
Scotchbond Universal Comparator	0 of 51 (0%)	8 of 51 (15.7%)	0 of 51

Limitations and caveats (from the sponsor): Planned randomization of treating pairs of 2 molars or 2 premolars was not always followed. There were 16 subjects who had pairs of 1 molar and 1 premolar treated. These changes were not expected to impact the results of the study and no adjustments to the analysis plan were made.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20628774Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
Background: PubMed 19492717Perdigao J, Dutra-Correa M, Anauate-Netto C, Castilhos N, Carmo AR, Lewgoy HR, Amore R, Cordeiro HJ. Two-year clinical evaluation of self-etching adhesives in posterior restorations. J Adhes Dent. 2009 Apr;11(2):149-59.
Individual participant dataSharing planned: No

Related trials for Cavities of Teeth

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
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)

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.

Jorge Perdigao, DMD, MS, PhD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Scotchbond™ Universal Plus Adhesive and Scotchbond™ Universal Adhesive in people with Cavities of Teeth and Dental Decay, run by Solventum US LLC at 1 site in United States.

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 9 inclusion and 16 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 17 Dec 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 United States. 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?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Retention of Restorative Material (time frame: 24 months post-restoration). The study lists 3 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 NCT05248204, which also lists 2 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 17 Dec 2025.