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

Primary Purpose

Tooth Decay

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
restorative materials
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Decay

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al Azhar Univerisity

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

GROUP A

group b

group c

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

fracture and retention score
EXCELLENT GOOD POOR
gingival index
SCORE 0;1;2;3
radiographic pathology
PRESENT OR NOT

Secondary Outcome Measures

Full Information

First Posted
June 9, 2023
Last Updated
June 16, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05908136
Brief Title
Clinical and Radiographical Evaluation of Two Types of Composite Materialsstrip Crown in Primary Molars
Official Title
Restoration of the Primary Molars With Strip Crowns and Two Types of Composites
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP A
Arm Type
Active Comparator
Arm Description
• Group A: 12 primary molars received stainless steel crowns (SSCs).
Arm Title
group b
Arm Type
Active Comparator
Arm Description
• Group B: 12 primary molars received resin composite strip crowns (RCSCs).
Arm Title
group c
Arm Type
Active Comparator
Arm Description
• Group C: 12 primary molars received zirconium-filled composite strip crowns (ZFSCs).
Intervention Type
Other
Intervention Name(s)
restorative materials
Other Intervention Name(s)
composite materials, strip crown
Intervention Description
two types of composite with strip crown in primary molars
Primary Outcome Measure Information:
Title
fracture and retention score
Description
EXCELLENT GOOD POOR
Time Frame
6 months
Title
gingival index
Description
SCORE 0;1;2;3
Time Frame
6 months
Title
radiographic pathology
Description
PRESENT OR NOT
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Al Azhar Univerisity
City
Cairo
State/Province
Nasr City
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
PLAN FOR SHARE with other researchers
IPD Sharing Time Frame
6 MONTHS
IPD Sharing Access Criteria
NO ACCESS
Citations:
PubMed Identifier
24490090
Citation
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.
Results Reference
result

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

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