Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05557682 |
| Other study ID # |
FDBUEREC21-30 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
British University In Egypt |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Aim of the study
The aim of the presented study is to evaluate:
I- The clinical performance of flowable polyacid-modified composite resin 'compomer' and
resin-modified glass-ionomer cement in prepared Class II cavities in primary molars over a
period of 6 months.
II- Psychological impact of the coloured material used on the child's behavior towards the
dental procedure.
Materials and Methods Forty primary molars from healthy children between ages of four and
seven years will be included in this study, parents will be asked to sign an informed consent
on behalf of the children. Statistical power analysis was performed using G-power program. An
alpha type error of 0.05, a beta power of 0.95 and a N2/N1 ratio of 1 was used. This study
have the approval of the research ethics committee BUE. This study will be executed in the
Faculty of Dentistry, BUE, Department of Pediatric Dentistry. Subjects will be selected from
children who are seeking dental treatment at the Pediatric Dentistry and Dental Public Health
clinic in the Faculty of Dentistry, BUE. Children with detectable caries for Class II cavity
preparation will be classified randomly under the different treatment groups. Group A:
Colored polyacid modified composite resin , Group B: Glass ionomer cement All groups will be
restored according to material used. Restorations will be assessed for marginal adaptation,
marginal discoloration, anatomic form, and secondary caries. The assessment of all
restorations will be carried out at 24-hours, 3, 6 months post-operatively under normal
clinical conditions with a dental operating light, a mouth mirror and a dental explorer. The
impact of the color of the material used on the child's attitude will be assessed once
through a questionnaire given to the child at the beginning of the first dental visit in
which each child will be asked to choose from pictures that indicate their preference
regarding the use of colored and non-colored restorative materials and how their choice will
affect their attitude whether they will be happy, sad or neutral.
As per the scheduled follow up visits, these are the regular follow up intervals for any
child undergoing dental treatment. Accordingly, it won't be of an extra burden on the
patient/ parent.
Statistical analysis Data will be collected, tabulated and statistically analyzed using
statistical package for Social Science (SPSS 15.0.1 for windows; SPSS Inc, Chicago, IL,
2001). Data will be presented and suitable analysis will be done according to the type of
data obtained for each parameter.
Description:
Aim of the study
The aim of the presented study is to evaluate:
I- The clinical performance of flowable polyacid-modified composite resin 'compomer' and
resin-modified glass-ionomer cement in prepared Class II cavities in primary molars over a
period of 6 months.
II- Psychological impact of the coloured material used on the child's behavior towards the
dental procedure.
Materials and Methods Forty primary molars from children between ages of four and seven years
will be included in this study, parents will be asked to sign an informed consent on behalf
of the children. Statistical power analysis was performed using G-power program. An alpha
type error of 0.05, a beta power of 0.95 and a N2/N1 ratio of 1 was used. This study will
have the approval of the research ethics committee BUE and will be registered in clinical
trial website.
This study will be executed in the Faculty of Dentistry, ,BUE,Department of Pediatric
Dentistry. Subjects will be selected from children who are seeking dental treatment at the
Pediatric Dentistry and Dental Public Health clinic in the Faculty of Dentistry, BUE.
Children with detectable caries for Class II cavity preparation will be classified randomly
under the different treatment groups.
Group A: Colored polyacid modified composite resin Group B: Glass ionomer cement
Children will be recruited according to the following inclusion and exclusion criteria:
Table 1: Inclusion and exclusion criteria Inclusion criteria Exclusion criteria Radiographic
examination (bite-wing radiograph) showing evidence of proximal caries. Radiographic
examination (bite-wing radiograph) showing evidence of occlusal caries only, or showing
evidence of proximal caries extending to the pulp.
Proximal contact with adjacent healthy or restored tooth. Isolated tooth No signs or symptoms
of pulp involvement Signs or symptom of pulp involvement.
No signs of periapical pathosis Signs of periapical pathosis No signs of periodontal
involvement Signs of periodontal involvement 2 years at least till normal exfoliation Less
than 2 years for exfoliation 2/3 of the root is still present Less than 2/3 of the root is
present No restoration present Restoration present No cuspal involvement Cuspal involvement
All groups will be restored according to material used. Restorations will be assessed for
marginal adaptation, marginal discoloration, anatomic form, and secondary caries. The
assessment of all restorations will be carried out at 24-hours, 3, 6 months post-operatively
under normal clinical conditions with a dental operating light, a mouth mirror and a dental
explorer.
The impact of the color of the material used on the child's attitude will be assessed once
through a questionnaire given to the child at the beginning of the first dental visit in
which each child will be asked to choose from pictures that indicate their preference
regarding the use of colored and non-colored restorative materials and how their choice will
affect their attitude whether they will be happy, sad or neutral.
It is worth mentioning that the children selected for this study will be given meticulous
oral hygiene measures instructions and will undergo full dental treatment during the course
of the study thus, there are absolutely no risks on the human participants especially that
only the decayed molars will be filled using the two different materials used in this study.
However, chances of loss of the filling material, secondary caries, loss of the anatomical
form, marginal discolouration and loss of the marginal adaptation might still be a subject of
concern.
If these materials have been proved to be durable, more accepted by the children and less
technique sensitive to the clinician then the patient/parent will be informed by the results
and given the choice in case he/she wishes to change the restoration at any point and time.
As per the scheduled follow up visits, these are the regular follow up intervals for any
child undergoing dental treatment. Accordingly, it won't be of an extra burden on the
patient/ parent.
Statistical analysis Data will be collected, tabulated and statistically analyzed using
statistical package for Social Science (SPSS 15.0.1 for windows; SPSS Inc, Chicago, IL,
2001). Data will be presented and suitable analysis will be done according to the type of
data obtained for each parameter.
1. Descriptive Statistics: frequency and percentage of non-numerical data
2. Analytical Statistics: The Cochran Q procedure tests the null hypothesis that multiple
related proportions are the same. The Cochran test is a multivariate extension of the
McNemar test used for two related samples.
