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Clinical Performance and Psychological Impact of Colored Restorations Cement in Primary Molars

NCT05557682 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-09-28

No results posted yet for this study

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.

Conditions

  • Pediatric Dentistry

Interventions

OTHER

composite restorative treatment

Restorative treatment using dental materials

Sponsors & Collaborators

  • British University In Egypt

    lead OTHER

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-04-01
Completion
2022-05-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557682 on ClinicalTrials.gov