Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03321474 |
| Other study ID # |
CEBD-CU-2017-10-24 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2019 |
| Est. completion date |
May 2020 |
Study information
| Verified date |
March 2019 |
| Source |
Cairo University |
| Contact |
zeinab saeed Elshamy, MDS |
| Phone |
01125195692 |
| Email |
zeinab.alshamy[@]dentistry.cu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Patient with discolored anterior teeth and need conservative restoration treated with all
ceramic esthetic laminate veneers. The Patient will be satisfied with restoration mimic the
surrounding natural teeth, but conventional preparation shows approximately 60% of veneer
failure in form of color change and nearly 67% Fractures of laminate veneers so the modified
gull wing preparation is a significant factor affecting the final esthetic especially in
discolored teeth and improve fracture resistance of the restoration.
Description:
This trial will be conducted on patient from the outpatient clinic in the fixed
prosthodontics clinic, faculty of oral and dental medicine, Cairo University Adherence
session will take place in the presence of the patients in the initial visit. This include
that patient will be informed by Z Elshamy about the study steps and maintenance of oral
hygiene instructions. Participants will be asked by Z Elshamy if they have any problems.
Motivation and enforcing the maintenance of oral hygiene measures by ZElshamy.
The visits will be designated as follow:
Visit 1: Preoperative records, face-to-face adherence reminder session, clinical,
radiographic examination, intraoral photographs, and primary impression for diagnostic cast
construction. Visit 2: teeth preparation, secondary impression using addition silicone rubber
base material and temporary restoration. Visit 3: one week after the second visit, try in for
the restoration will be done.
Visit 4: placement and permanent cementation of the final restoration. Visit 5: Every 2
months post operatively follow-up visit for one year. Sample size: Since no previously
published effect size data regarding the effectiveness of neither the intervention nor the
control exist, an estimated sample of (20 restorations) would be used with allocation ratio
1:1 Recruitment: The patients fulfilled the inclusion criteria will be selected from the
outpatient clinic of the fixed prosthodontics department - Cairo University. Screening of
patients will be carried out until the target population is reached.
Methods: Assignment of interventions (for controlled trial) Sequence generation. The
participant teeth will be allocated into two groups with 1:1 allocation ratio by using
computerized Sequence generation.
Plans to promote participant retention &complete follow up :
Telephone numbers and address of the patient included in the study will be Recorded. All
patients will be given a phone call before the next appointment.
Data management: All data will be entered electronically. Patient files are to be stored in
Numerical order in a secured place. This will be carried out by ZElshamy Statistical methods
Data analysis All Data will be collected, checked, revised, tabulated and entered into the
computer by ZElshamy. Quantitative variables from the normal distribution will be expressed
as mean and standard deviation (SD) values. To test the significant differences between two
groups at different follow-up period's student t-test will be used. Significant level will be
set at P ≤ 0.05 Statistical analysis will be done using Statistical Package for Social
Sciences, Version 21.0 (SPSS, IBM, Chicago, III, USA) for Windows. Data monitoring: The main
supervisor is responsible for data monitoring if harms arise, an interim analysis will be
done. (El Mahallawi O).
Harms: Any adverse effect of pain or even failure will be recorded, documented and treated.
Consent: Researcher will discuss the trial with all patients. Patients will then be able to
have an informed discussion with the researcher. A researcher will obtain written consent
from patients willing to participate in the trial. All consent forms will be in the Arabic
language Confidentiality :All study-related information will be stored securely. All
participants' information will be stored in locked file cabinets in areas with limited
access. All data collection, process, and administrative forms will be identified by a coded
ID [identification] number only to maintain participant confidentiality. All records that
contain names or other personal identifiers will be stored separately from study records
identified by code number. All local databases will be secured with password-protected access
systems.
Access to data :The investigator and supervisors will be given access to the data sets. All
data sets will be password protected. To ensure confidentiality, Participant study
information will become confidentially Ancillary and post-trial care :All patients will be
followed up until complete period study& patients' satisfactions occur. As any prosthetic
treatment post insertion adjustment is necessary and in this trial recalls maintenance.
Dissemination policy : Study results will be published as partial fulfillment of the
requirements for PHD degree in fixed prosthodontics.
- Topics suggested for presentation or publication will be circulated to the authors.
Data collection methods:
Primary outcome: The fracture of the restoration of the two groups will be assessed using the
modified United States public health service ( USPHS) criteria Secondary outcome: Color
changes of the two groups will be assessed using the modified United States public health
service (USPHS) criteria
