Tooth DecayNCT05908136
Clinical and Radiographical Evaluation of Two Types of Composite Materialsstrip Crown in Primary Molars
A study testing restorative materials in people with Tooth Decay, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Tooth Decay
- What is being tested?
- restorative materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Badly decayed non-restorable tooth indicated for extraction.
- Patients with parafunctional habits like bruxism.
- Systemic diseases with oral manifestation or blood diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read more
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.
Read the 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.
- Conditions
- Tooth Decay
- Being tested
- restorative materials
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restorative materialsOther
Also called composite materials, strip crown
two types of composite with strip crown in primary molars
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Active comparator | • Group A: 12 primary molars received stainless steel crowns (SSCs). Receives: Other: restorative materials |
| group b | Active comparator | • Group B: 12 primary molars received resin composite strip crowns (RCSCs). Receives: Other: restorative materials |
| group c | Active comparator | • Group C: 12 primary molars received zirconium-filled composite strip crowns (ZFSCs). Receives: Other: restorative materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
fracture and retention score
EXCELLENT GOOD POOR
Measured: 6 months
gingival index
SCORE 0;1;2;3
Measured: 6 months
radiographic pathology
PRESENT OR NOT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibraheem Mohammed Mohamed Elshenawe, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908136
- Sponsor's protocol ID
- crowns in pediatric dentistry
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PLAN FOR SHARE with other researchers
Publications
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.
PubMed 24490090
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of the Primary Molars With Strip Crowns and Two Types of Composites
- ClinicalTrials.gov ID
- NCT05908136
- Acronym / sponsor ID
- crowns in pediatric dentistry
- Conditions
- Tooth Decay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Active comparator | Other: restorative materials• Group A: 12 primary molars received stainless steel crowns (SSCs). |
| group b | Active comparator | Other: restorative materials• Group B: 12 primary molars received resin composite strip crowns (RCSCs). |
| group c | Active comparator | Other: restorative materials• Group C: 12 primary molars received zirconium-filled composite strip crowns (ZFSCs). |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Badly decayed non-restorable tooth indicated for extraction.
- Patients with parafunctional habits like bruxism.
- Systemic diseases with oral manifestation or blood diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| restorative materialsAlso: composite materials, strip crowntwo types of composite with strip crown in primary molars | Other | GROUP A, group b, group c |
Primary outcome
fracture and retention score
Time frame: 6 months
EXCELLENT GOOD POOR
gingival index
Time frame: 6 months
SCORE 0;1;2;3
radiographic pathology
Time frame: 6 months
PRESENT OR NOT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 24490090Jeong 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.
- Individual participant dataSharing planned: Yes. PLAN FOR SHARE with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restorative materials in people with Tooth Decay, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fracture and retention score (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05908136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.