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

NCT05908136 | Completed

• 1 other identifier: crowns in pediatric dentistry
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Decay

Outcome Measures

Primary Outcomes (3)

• fracture and retention score

  EXCELLENT GOOD POOR

  6 months

• gingival index

  SCORE 0;1;2;3

  6 months

• radiographic pathology

  PRESENT OR NOT

  6 months

Study Arms (3)

GROUP A

ACTIVE COMPARATOR

• Group A: 12 primary molars received stainless steel crowns (SSCs).

Other: restorative materials

group b

ACTIVE COMPARATOR

• Group B: 12 primary molars received resin composite strip crowns (RCSCs).

Other: restorative materials

group c

ACTIVE COMPARATOR

• Group C: 12 primary molars received zirconium-filled composite strip crowns (ZFSCs).

Other: restorative materials

Interventions

restorative materials OTHER

two types of composite with strip crown in primary molars

Also known as: composite materials, strip crown

GROUP A; group b; group c

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Badly decayed non-restorable tooth indicated for extraction.
• Patients with parafunctional habits like bruxism.
• Systemic diseases with oral manifestation or blood diseases.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar Univerisity

Cairo, NASR CITY, Egypt

Location

Related Publications (1)

• Jeong MA, Kim AH, Shim YS, An SY. Restoration of strip crown with a resin-bonded composite cement in early childhood caries. Case Rep Dent. 2013;2013:581934. doi: 10.1155/2013/581934. Epub 2013 Sep 24.

  PMID: 24490090 RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 MONTHS
• Access Criteria: NO ACCESS

Locations

EG (1)