search
Back to results

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

Primary Purpose

Recurrent Caries Incidence

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
adhesive bond with chlorhexidine
Time variable
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Caries Incidence

Eligibility Criteria

20 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Oral Medicine and Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

conventonal adhesive

Time variable

Arm Description

peak lc bond

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

Outcomes

Primary Outcome Measures

recurrent caries incidence
FDI clinical and radiographic criteria

Secondary Outcome Measures

Full Information

First Posted
April 30, 2017
Last Updated
July 22, 2019
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT03139409
Brief Title
Digital Radiography in Detection of Recurrent Caries Underneath Chlorhexidine Containing Adhesive Versus Conventional Adhesive After One Year Follow up: Randomized Clinical Trial
Official Title
Digital Radiography in Detection of Recurrent Caries Underneath Chlorhexidine Containing Adhesive Versus Conventional Adhesive After One Year Follow up.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
July 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Caries Incidence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventonal adhesive
Arm Type
Active Comparator
Arm Description
peak lc bond
Arm Title
Time variable
Arm Type
Other
Arm Description
Diagnosis and follow up will be immediate ,6 months later and 1 year
Intervention Type
Procedure
Intervention Name(s)
adhesive bond with chlorhexidine
Other Intervention Name(s)
peak universal bond
Intervention Description
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
Other
Intervention Name(s)
Time variable
Intervention Description
Diagnosis and follow up will be immediate , 6 months later and 1 year
Primary Outcome Measure Information:
Title
recurrent caries incidence
Description
FDI clinical and radiographic criteria
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Faculty of Oral Medicine and Dentistry
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs