Digital Radiography in Detection of Recurrent Caries Underneath Chlorhexidine Containing Adhesive Versus Conventional Adhesive After One Year Follow up: Randomized Clinical Trial

NCT ID: NCT03139409

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-20
• Study Completion Date: 2018-07-27

Brief Summary

This study will be conducted to compare the effect of chlorexidine containing adhesive versus conventional one in prevention of secondary caries lesion underneath composite restoration over one year follow up null hypothesis

Detailed Description

each patient will have at least 2 class II cavities.one will be restored using the intervention and the other using the control.

Digital radiographs will be taken and the images will be processed using a digital system. Then the teeth will be evaluated by expert in dental radiology who had no awareness of the results of the visual inspection. The examiner will use a radiograph viewer and a radiographic film magnifier to determine the presence or absence of radiolucency underlying the restoration. The clinical and radiographic examination will be assessed according to the FDI World Dental Federation clinical criteria for the evaluation of direct and indirect restorations The aim of this equivalent trial is to examine if the chlorhexidine containing adhesive is effective as the conventional adhesive in prevention of recurrent caries under resin composite restoration after one year follow up in high caries risk patients with class II cavities. Based on the previous papers by Papagiannoulis et al .,1999 and kohler et al.,2000, the success rate reported was about 95% (absence of caries). If there is truly no difference between the standard and experimental treatment, then 37 patients are required to be 80% sure that the limits of a two-sided 90% confidence interval will exclude a difference between the standard and experimental group of more than 15 %. The sample size was calculated by sealed envelope online.

Data will be analyzed using IBM SPSS advanced statistics (statistical package for social sciences), version 21 ( SPSS Inc. Chicago , IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Comparisons between categorical variables will be performed using the chi square test. An equivalent limit will be tested. A P -value less than or equal 0.05 will be considered statistically significant. All tests will be two tailed

Conditions

Recurrent Caries Incidence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

conventonal adhesive

peak lc bond

Group Type: ACTIVE_COMPARATOR

adhesive bond with chlorhexidine

Intervention Type: PROCEDURE

Peak® Universal Bond (ultradent, 505 West 10200 South, South Jordan, UT 84095،USA ) light-Cured Adhesive with Chlorhexidine (0.2%), 7.5% filler, phosphate and containing hydroxyethyl methacrylate with ethyl alcohol as the carrier. its viscosity has been optimized for minimal film thickness (2μm) and superior strength. using self etch adhesive with chlorexidine as one step in the bonding component may give chance to proper penetration of resin tags, decrease the micro-organisms due to the antibacterial effect of chlorexidine (Bin-Shuwaish, 2016) and also the addition of chlorexidine in bonding system may be an excellent tool to increase the stability of collagen fibrils within the hybrid layer against host-derived metaloproteinases (MMP) without the need for additional steps for the bonding protocol (Stanislawczuk, et al., 2009), which results in better durability and good restorations with decreasing the incidence of recurrent caries

Time variable

Diagnosis and follow up will be immediate ,6 months later and 1 year

Group Type: OTHER

Time variable

Intervention Type: OTHER

Diagnosis and follow up will be immediate , 6 months later and 1 year

Interventions

adhesive bond with chlorhexidine

Peak® Universal Bond (ultradent, 505 West 10200 South, South Jordan, UT 84095،USA ) light-Cured Adhesive with Chlorhexidine (0.2%), 7.5% filler, phosphate and containing hydroxyethyl methacrylate with ethyl alcohol as the carrier. its viscosity has been optimized for minimal film thickness (2μm) and superior strength. using self etch adhesive with chlorexidine as one step in the bonding component may give chance to proper penetration of resin tags, decrease the micro-organisms due to the antibacterial effect of chlorexidine (Bin-Shuwaish, 2016) and also the addition of chlorexidine in bonding system may be an excellent tool to increase the stability of collagen fibrils within the hybrid layer against host-derived metaloproteinases (MMP) without the need for additional steps for the bonding protocol (Stanislawczuk, et al., 2009), which results in better durability and good restorations with decreasing the incidence of recurrent caries

Intervention Type: PROCEDURE

Time variable

Diagnosis and follow up will be immediate , 6 months later and 1 year

Intervention Type: OTHER

Other Intervention Names

peak universal bond

Eligibility Criteria

Inclusion Criteria

• Patients should be 20-25 years of age with high caries risk. Patients should have an acceptable oral hygiene level. Patients must have at least two proximal lesions to be restored.

Exclusion Criteria

Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion. Lack of compliance

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Katreen Tawfik

Internal Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Oral Medicine and Dentistry

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CEBC-CU-2017-044-16

Identifier Type: -

Identifier Source: org_study_id