The Effect of Different Adhesion Strategies on the Clinical Success

The Effect of Different Adhesion Strategies on the Clinical Success of Non-caries Cervical Restorations.

The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. They have to be treated for a minimum of four non-cancerous cervical lesions in their mouths.Four non-carious cervical lesions from patients will be separated into four groups, and adhesive material will be applied to the lesions in each group using different procedures. Evaluation will be performed based on World Dental Federation (FDI) criteria after initial, ½, 1, 2, 3, 4, and 5 years.

Study Overview

• Status: Not yet recruiting
• Conditions: Secondary Caries; Dental Restoration Failure of Marginal Integrity; Poor Aesthetic of Existing Restoration of Tooth; Unacceptable Morphology of Tooth Restoration
• Intervention / Treatment: Procedure: Treatment of cervical lesions

Detailed Description

The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. They have to be treated for a minimum of four non-cancerous cervical lesions in their mouths.Four non-carious cervical lesions from patients will be separated into four groups, and adhesive material will be applied to the lesions in each group using different procedures. Evaluation will be performed based on World Dental Federation (FDI) criteria after initial, ½, 1, 2, 3, 4, and 5 years. In each evaluation period, esthetic (surface gloss, surface coloration, marginal discoloration, color match and translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity and vitality, caries recurrence) will be evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 41
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Over the age of 18 years
• Good oral hygiene normal occlusal relationship with natural dentition
• At least 20 teeth are in occlusion The tooth with the lesion must be vital. non-mobile and non-carious
• Accepts Healthy Volunteers

Exclusion Criteria:

under the age of 18

• Poor oral hygiene poor general health condition
• Bruxism or uncontrolled parafunction
• Patients with periodontal or gingival diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adhesion Strategies; Four non-carious cervical lesions from patients will be separated into four groups according to differnet adhesion strategies	Procedure: Treatment of cervical lesions; Four non-carious cervical lesions from patients will be separated into four groups according to according to the adhesion trategies described below: adhesive material will be applied in total-etch mode,; adhesive material will be applied in self-etch,; universal adhesive material will be applied for 10 sec. in total-etch mode, which includes rubbing,; universal adhesive material will be applied for 10 sec. in self-etch mode, which includes rubbing,; Other Names: differnet adhesion procedures
Other: Different procedure; All lesions to which adhesives are applied according to different adhesion strategies will be restored with the same type of composite material.	Procedure: Treatment of cervical lesions; Four non-carious cervical lesions from patients will be separated into four groups according to according to the adhesion trategies described below: adhesive material will be applied in total-etch mode,; adhesive material will be applied in self-etch,; universal adhesive material will be applied for 10 sec. in total-etch mode, which includes rubbing,; universal adhesive material will be applied for 10 sec. in self-etch mode, which includes rubbing,; Other Names: differnet adhesion procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention rate of restorations	survival of restorations discoloration, color match, translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity). and vitality, caries recurrence)	Restorations will be evaluated 1 week, 6 months, 12 months and 24 months after finishing.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention rate of restorations	survival of restorations discoloration, color match, translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity). and vitality, caries recurrence)	Restorations will be evaluated 36 months, 48 months and 60 months after finishing.

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: 2018/58

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No