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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04291872
Other study ID # MarmaraU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date September 2017

Study information

Verified date February 2020
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: The aim of this study was to assess the influence of heated in the clinical success of proximal high viscosity glass ionomer cement (GIC) restorations in primary molars.

Material & Method: This randomized, split mouth, multicenter study was performed in four different centers including 88 patients aged between 5-7 years old. Selection criteria included clinically and/or radiographically detected proximal caries extending into the dentin tissue. A total of 250 primary molars were restored with a bulk fill GIC (Equia Forte, GC, Europe) and randomly allocated to one of the following groups: 1) non-heated (n = 125) and 2) heated (n = 125). LED light (GC- D-Light DUO, Tokyo Japan) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec for heat application. All restorations were clinically evaluated using modified USPHS criteria at the baseline, 6 months and 12 months. Chi-square test, Fisher's Exact Chi-square test, Continuity (Yates) correction, Fisher Freeman Halton test and Mc Nemar test were used to compare qualitative data with descriptive statistical methods (frequency). Kaplan Meier and Life Tables were used for survival analysis. P value < 0.05 was considered statistically significant.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date September 2017
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 7 Years
Eligibility Inclusion Criteria:

- Subject is mentally and systemically healthy

- Subject has at least two approximal carious lesions at both sides of jaws

- Subject has a normal occlusal relationship with natural dentition

- Subject has at least one adjacent tooth contact

Exclusion Criteria:

- Subject has history of bruxism,

- Subject has allergies to ingredients of glass ionomer based restorative materials.

- Cavity/Caries has highly mineralized pigmented lesions, hypoplasia, fracture or cracks,

- Subject has abrasion, erosion, abfraction,

- Subject has fistula, abscess or pathological mobility,

- Subject has pain, pulp exposure

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Glass -Ionomer Cement with /without Led Light Cure
Teeth were restored as same protocole with non-Heated Group. LED light (GC- D-Light DUO) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical success assessment measurement All restorations were evaluated by using Modified US Public Health Service criteria (modified USPHS criteria). Marginal Integrity (MI)), Marginal Discoloration (MD), Secondary Caries (SC), Anatomic Form (AF), and retention (R) were evaluated. A restoration was considered a failure when codes Charlie (C) and D (Delta) were registered. Codes A (Alpha) and B (Bravo) was considered a success or acceptable. follow up period was baseline, 6th months, 12th months. 12 months.
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