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New dental glue tested for stronger fillings
NCT ID NCT05248204
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new dental adhesive (glue) used to bond fillings to teeth. 51 adults with at least two cavities in back teeth received one filling with the new adhesive and one with the standard adhesive. The goal was to see if the new adhesive works as well as the standard one in keeping fillings in place and preventing cracks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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51 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Mar 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The Subject is between the ages of 18 and 70 years old at time of consent. 2. 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). 3. 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 4. 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. 5. The Subject is able and willing to sign Informed Consent Form in English without assistance. 6. The Subject is able and willing to be available for all scheduled study visits. 7. The Subject is in good general health (ie, meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria). 8. The selected teeth need to have occlusal contact with an antagonistic natural tooth. 9. The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months. Exclusion Criteria: 1. The Subject has a history of adverse reaction to any materials used in this study. 2. The Subject is pregnant or breast feeding at the time of screening. 3. The Subject has fewer than 20 teeth. 4. The Subject is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study. 5. The Subject has advanced periodontal disease (ie, Grace \& Smales Mobility Index grade ≥ 2) that involve the study teeth. 6. The Subject had orthodontic appliance treatment within the previous 3 months. 7. The Subject has pronounced enamel wear facets, indicating severe, on-going bruxism. 8. The Subject has severe xerostomia. 9. The study tooth has a history of or existing, prolonged tooth hypersensitivity. 10. The study tooth is an abutment for fixed or removable prostheses. 11. The study tooth has a fracture or is visibly cracked such that it may impact the longevity of the tooth. 12. The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring system. 13. The Subject is unable to understand study procedures or provide consent in English. 14. 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Minnesota School of Dentristry
Minneapolis, Minnesota, 55455, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.