Clinical and Radiographical Evaluation of Two Types of Composite Materialsstrip Crown in Primary Molars

June 16, 2023 updated by: Ibraheem Mohammed Mohamed Elshenawe, Al-Azhar University

Restoration of the Primary Molars With Strip Crowns and Two Types of Composites

Alterations in oral health of children interfere with their quality of life. Dental caries is the most common public health problem of children . The disease is the result of a complex interaction between acid producing tooth-adherent bacteria and fermentable carbohydrates. Over time, the acids in the dental plaque demineralize enamel and dentin in the fissures and the smooth surfaces of the tooth. The earliest visual sign of dental caries is white spot lesion. If demineralization continues, the surfaces of the white spot will cavitate, resulting in a cavity. If demineralization environment is reduced or eliminated, white spot lesions may remineralize and not progress. Risk factors include high numbers of cariogenic bacteria, high frequency sugar consumption, inadequate salivary flow, insufficient fluoride exposure, poor oral hygiene, and poverty.

The early diagnosis and management of caries still a challenge of dental care for children . The prefabricated metal crowns are often the first choice for the repair of severely damaged primary teeth and have been one of the most effective and efficient methods of tooth restoration in pediatric dentistry since Humphrey first used them in pediatric patients in 1950 . They are used to restore primary or permanent teeth with extensive or multisurface cavities, cervical decalcification, and/or developmental defects .

The prefabricated metal crowns have many advantages over other crown types and dental restorative materials . Their life span is the same as that of an intact primary tooth, they provide protection to the residual tooth structure that may have been weakened after excessive caries removal, the technique sensitivity or the risk of making errors during their application is low and their cost is low .

Despite many advantages, the metal appearance of these crowns is unpleasant to the parents and children and they prefer tooth-colored restorations to silver-colored fillings regardless of location of restorations . Inflammation of the surrounding gingival tissue is a problem frequently associated with prefabricated metal crowns. The incidence of gingivitis has been reported to be higher around poorly fitting crowns than around the crowns considered to be well adapted .

Considering the increasing demand for esthetic restorations, several treatment options have been proposed for primary teeth to overcome this problem such as strip crowns, pre-veneered stainless steel crowns and zirconia crowns .

Strip crown was introduced by Webber et al., in 1979 . strip crowns are available in different brands but the most commonly used resin composite strip crowns worldwide is 3M ESPE crown (3M ESPE Dental). Composite resin strip crowns (SC) have been utilized for over 2 decades to restore carious primary teeth . In spite of a long time of using, there is a paucity of literature concerning the clinical success of these crowns .

Incorporation of ceramic nanofibers in dental composites can significantly improve their mechanical properties and fracture toughness and thus may extend their service life.

This study aimed to assess clinically and radiographicaly of primary teeth restored with stability of the glassionomer and two composite material crown restoration using the preformed strip crown technique in primary molars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Alterations in oral health of children interfere with their quality of life. Dental caries is the most common public health problem of children . The disease is the result of a complex interaction between acid producing tooth-adherent bacteria and fermentable carbohydrates. Over time, the acids in the dental plaque demineralize enamel and dentin in the fissures and the smooth surfaces of the tooth. The earliest visual sign of dental caries is white spot lesion. If demineralization continues, the surfaces of the white spot will cavitate, resulting in a cavity. If demineralization environment is reduced or eliminated, white spot lesions may remineralize and not progress. Risk factors include high numbers of cariogenic bacteria, high frequency sugar consumption, inadequate salivary flow, insufficient fluoride exposure, poor oral hygiene, and poverty.

The early diagnosis and management of caries still a challenge of dental care for children . The prefabricated metal crowns are often the first choice for the repair of severely damaged primary teeth and have been one of the most effective and efficient methods of tooth restoration in pediatric dentistry since Humphrey first used them in pediatric patients in 1950 . They are used to restore primary or permanent teeth with extensive or multisurface cavities, cervical decalcification, and/or developmental defects .

The prefabricated metal crowns have many advantages over other crown types and dental restorative materials . Their life span is the same as that of an intact primary tooth, they provide protection to the residual tooth structure that may have been weakened after excessive caries removal, the technique sensitivity or the risk of making errors during their application is low and their cost is low .

Despite many advantages, the metal appearance of these crowns is unpleasant to the parents and children and they prefer tooth-colored restorations to silver-colored fillings regardless of location of restorations . Inflammation of the surrounding gingival tissue is a problem frequently associated with prefabricated metal crowns. The incidence of gingivitis has been reported to be higher around poorly fitting crowns than around the crowns considered to be well adapted .

Considering the increasing demand for esthetic restorations, several treatment options have been proposed for primary teeth to overcome this problem such as strip crowns, pre-veneered stainless steel crowns and zirconia crowns .

Strip crown was introduced by Webber et al., in 1979 . strip crowns are available in different brands but the most commonly used resin composite strip crowns worldwide is 3M ESPE crown (3M ESPE Dental). Composite resin strip crowns (SC) have been utilized for over 2 decades to restore carious primary teeth . In spite of a long time of using, there is a paucity of literature concerning the clinical success of these crowns .

Incorporation of ceramic nanofibers in dental composites can significantly improve their mechanical properties and fracture toughness and thus may extend their service life.

This study aimed to assess clinically and radiographicaly of primary teeth restored with stability of the glassionomer and two composite material crown restoration using the preformed strip crown technique in primary molars.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nasr City
      • Cairo, Nasr City, Egypt
        • Al Azhar Univerisity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Primary molars indicated for crown restoration (pulp treated molars indicated for crown

Co-operative child(Frankel scale +ve and ++ve)

The age ranged from 4 to 7 years regardless of sex or socioeconomic background.

Exclusion Criteria:

Badly decayed non-restorable tooth indicated for extraction.

Patients with parafunctional habits like bruxism.

Systemic diseases with oral manifestation or blood diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP A
• Group A: 12 primary molars received stainless steel crowns (SSCs).
two types of composite with strip crown in primary molars
Other Names:
  • composite materials
  • strip crown
Active Comparator: group b
• Group B: 12 primary molars received resin composite strip crowns (RCSCs).
two types of composite with strip crown in primary molars
Other Names:
  • composite materials
  • strip crown
Active Comparator: group c
• Group C: 12 primary molars received zirconium-filled composite strip crowns (ZFSCs).
two types of composite with strip crown in primary molars
Other Names:
  • composite materials
  • strip crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fracture and retention score
Time Frame: 6 months
EXCELLENT GOOD POOR
6 months
gingival index
Time Frame: 6 months
SCORE 0;1;2;3
6 months
radiographic pathology
Time Frame: 6 months
PRESENT OR NOT
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • crowns in pediatric dentistry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

PLAN FOR SHARE with other researchers

IPD Sharing Time Frame

6 MONTHS

IPD Sharing Access Criteria

NO ACCESS

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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