5-year Clinical Evaluation of Cavity Lining on the Restoration

NCT03802539 | Unknown

• 1 other identifier: HEK 11/54-8
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this double-blind, randomized trial is to compare the clinical performance of a composite restorations in root surface carious lesions with or without resin modified glass ionomer lining.

Conditions

Teeth; Lesion; Dental Root Caries

Keywords

Root caries; Cavity lining; Composite resin restorations; Self-etch adhesive

Outcome Measures

Primary Outcomes (1)

• Retention Outcome

  1.Retention Alpha for at least 90% of the restorations The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA (American Dental Association) guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assessed as alpha (retentive restoration) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.

  5 years

Study Arms (2)

Glass Liner

EXPERIMENTAL

Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin

Device: Glass Liner

No liner

NO INTERVENTION

Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin

Interventions

Glass Liner DEVICE

restoration of root caries according to two different protocols

Glass Liner

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-hospitalized, healthy patients that were seeking dental treatment for caries lesions on the root surface

You may not qualify if:

• Patients who were under the age of 18 years
• Complex medical history
• Severe or chronic periodontitis
• Extreme carious activity
• Heavy bruxism
• Very deep or superficial carious lesions
• Previously restored and abutment teeth

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (1)

• Koc Vural U, Gokalp S, Kiremitci A. Effect of cavity lining on the restoration of root surface carious lesions: a split-mouth, 5-year randomized controlled clinical trial. Clin Oral Investig. 2020 Feb;24(2):979-989. doi: 10.1007/s00784-019-03001-z. Epub 2019 Jul 4.

  PMID: 31273529 DERIVED

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2019
• First Posted: January 14, 2019
• Study Start: January 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: January 1, 2020
• Last Updated: January 14, 2019

Record last verified: 2019-01