NCT06500546

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
33mo left

Started Sep 2024

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Sep 2024Jan 2029

First Submitted

Initial submission to the registry

June 28, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

June 28, 2024

Last Update Submit

July 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • retention rate of restorations

    Restorations will be evaluated 36 months, 48 months and 60 months after finishing.

Study Arms (2)

Adhesion Strategies

OTHER

Four non-carious cervical lesions from patients will be separated into four groups according to differnet adhesion strategies

Procedure: Treatment of cervical lesions

Different procedure

OTHER

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

Interventions

Four non-carious cervical lesions from patients will be separated into four groups according to according to the adhesion trategies described below: 1. adhesive material will be applied in total-etch mode, 2. adhesive material will be applied in self-etch, 3. universal adhesive material will be applied for 10 sec. in total-etch mode, which includes rubbing, 4. universal adhesive material will be applied for 10 sec. in self-etch mode, which includes rubbing,

Also known as: differnet adhesion procedures
Adhesion StrategiesDifferent procedure

Eligibility Criteria

Age14 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • under the age of 18
  • Poor oral hygiene poor general health condition
  • Bruxism or uncontrolled parafunction
  • Patients with periodontal or gingival diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: comparison of restoration success
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 15, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 1, 2029

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share