Efficiency of Different Modes of Universal Adhesive

NCT04271150 | Unknown

• 1 other identifier: KA-180016
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate and compare the clinical performance of a Universal adhesive's different application modes.

Conditions

Dental Caries; Adhesion

Outcome Measures

Primary Outcomes (5)

• Marginal adaptation

  Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation will evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable) Bravo: Marginal gap (\> 100μ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.

  From baseline to 6 year the change of restorations will be evaluated

• Marginal discoloration

  Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal discoloration. Marginal discoloration will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.

  From baseline to 6 year the change of restorations will be evaluated

• Retention

  Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed

  From baseline to 6 year the change of restorations will be evaluated.

• Anatomic form

  Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding anatomic form. Anatomic form will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.

  From baseline to 6 year the change of restorations will be evaluated.

• Color change

  Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding color change. Color changes will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.

  From baseline to 6 year the change of restorations will be evaluated.

Study Arms (2)

Self-etch

EXPERIMENTAL

Self-etch mode of the universal adhesive will be used

Device: Self-etch

Total-etch

ACTIVE COMPARATOR

Total etch mode of the universal adhesive will be used

Device: Total-etch

Interventions

Self-etch DEVICE

Universal adhesive with self-etch mode

Self-etch

Total-etch DEVICE

Universal adhesive with total-etch mode

Total-etch

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a need for at least two but not more than four posterior tooth-colored restorations
• the presence of teeth to be restored in occlusion
• teeth that were symptomless and vital
• a normal periodontal status
• a good likelihood of recall availability.

You may not qualify if:

• partly erupted teeth
• absence of adjacent and antagonist teeth
• poor periodontal status
• adverse medical history
• potential behavioral problems

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Links

• PUBMED
• PUBMED

MeSH Terms

Conditions

Dental Caries; Tissue Adhesions

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayse R Yazici, DDS, PhD

  Hacettepe University School of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: May 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2025
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)