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

NCT05557682 | Completed DMC

• 1 other identifier: FDBUEREC21-30
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• healing

  The assessment of all restorations will be carried out at 24-hours operatively under normal clinical conditions with a dental operating light, a mouth mirror and a dental explorer.

  3 months post-operatively

• healing

  The assessment of all restorations will be carried out at 3 months operatively under normal clinical conditions with a dental operating light, a mouth mirror and a dental explorer.

  3 months post-operatively

• healing

  The assessment of all restorations will be carried out at 6 months operatively under normal clinical conditions with a dental operating light, a mouth mirror and a dental explorer.

  6 months post-operatively

Secondary Outcomes (3)

• impact of colour

  24-hours, 3, 6 months post-operatively

• impact of colour

  3 months post-operatively

• impact of colour

  6 months post-operatively

Study Arms (2)

clinical performance

restoration of caries primary molars using two different restorative materials

Other: composite restorative treatment

psychological impact

evaluation of colour of restoration on the satisfaction of the children and impact on their hygiene

Interventions

composite restorative treatment OTHER

Restorative treatment using dental materials

Also known as: glass ionomer restorative treatment

clinical performance

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy children between ages of four and seven years will be included in this study

You may qualify if:

• Radiographic examination (bite-wing radiograph) showing evidence of proximal caries.
• Proximal contact with adjacent healthy or restored tooth.
• No signs or symptoms of pulp involvement
• No signs of periapical pathosis
• No signs of periodontal involvement
• years at least till normal exfoliation
• /3 of the root is still present
• No restoration present
• No cuspal involvement

You may not qualify if:

• Radiographic examination (bite-wing radiograph) showing evidence of occlusal caries only, or showing evidence of proximal caries extending to the pulp.
• Isolated tooth
• Signs or symptom of pulp involvement.
• Signs of periapical pathosis
• Signs of periodontal involvement
• Less than 2 years for exfoliation
• Less than 2/3 of the root is present
• Cuspal involovement
• Restoration present

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

the British University in Egypt

Cairo, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Dentistry

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: September 28, 2022
• Study Start: November 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)