One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations (NCT06265116) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations
Egypt48 participantsStarted 2024-01-23
Plain-language summary
to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period.
Who can participate
Age range20 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must present with at least four posterior primary compound proximal caries involving two surfaces, specifically occluso-mesial or occluso-distal cavities, with a corresponding International Caries Detection and Assessment System (ICDAS) score of 4 or 5.
* The buccolingual width of the lesion should be approximately less than two-thirds of the intercuspal distance.
* Teeth to be restored must be in normal occlusion with the natural antagonist teeth.
* Vital teeth with no signs of pulpal inflammation or pathological lesions.
* Normal periodontal status and good oral hygiene.
* Good likelihood of recall availability.
Exclusion Criteria:
* Patients with proximal cavities that extend beyond two surfaces or have a lesion buccolingual width greater than two-thirds of the intercuspal distance, or requiring cusp coverage.
* Partly erupted or endodontic treated teeth.
* Poor oral hygiene or severe periodontitis.
* Absence of neighboring or antagonist teeth.
* Patients with known allergy to any component of the study materials.
* Patients with unstable medical conditions.
* Patients with known unavailability to attend recall visits.
* Pregnant or lactating females.
* Patients with heavy para-functional habits, fractured, or visibly cracked teeth.
What they're measuring
1
Percentage of functional and biological properties for each group