Early Childhood CariesNCT04758221
Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: 3 Years Results
A study testing Treatment by composite coronal build-up in people with Early Childhood Caries and Pediatric Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Prospective single arm study was to evaluate the clinical success and/ or failure of resin-bonded composite coronal build-up retained by macro-retentive grooves for restoring mutilated primary maxillary incisors after 36 months. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Early Childhood Caries, Pediatric Disease, Dental Caries
- What is being tested?
- Treatment by composite coronal build-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2016to Jul 2020
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Only children in the age group of 2-5 years.
- Teeth affected due to caries or trauma with one or two or three surfaces affected or more.
Who cannot join
- • Any tooth nearing exfoliation or not fit for restoration.
- Patients with systemic problems which may interfere with general anesthesia.
- Teeth with excessive pathologic mobility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: Prospective Single Arm Study
Prospective single arm study was to evaluate the clinical success and/ or failure of resin-bonded composite coronal build-up retained by macro-retentive grooves for restoring mutilated primary maxillary incisors after 36 months.
Design: Forty two primary incisors out of 14 children, aged 2-5years, treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6, 12, 18, 24 and 36 months included in the study. The parameters recorded at the baseline and at the follow-up intervals were: retention, colour match, the number and location of the decayed surfaces (recurrent caries), chipping /fracture of the restoration and loss of restoration (failure).
Materials and Methods: A total of (14) pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study. A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micro-mechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth. The patients returned at the end of 6, 12, 18, 24 and 36 months and received clinical examinations. Another dentist (co-author) who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service (USPHS) criteria.
Read the detailed description
Purpose: The purpose of this study was to evaluate the clinical success and/ or failure of resin-bonded composite coronal build-up retained by macro-retentive grooves for restoring mutilated primary maxillary incisors after 36 months.
Design: Forty two primary incisors out of 14 children, aged 2-5years, treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6, 12, 18, 24 and 36 months included in the study. The parameters recorded at the baseline and at the follow-up intervals were: retention, colour match, the number and location of the decayed surfaces (recurrent caries), chipping /fracture of the restoration and loss of restoration (failure).
Materials and Methods: A total of (14) pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study. A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth. The patients returned at the end of 6, 12, 18, 24 and 36 months and received clinical examinations. Another dentist (co-author) who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service (USPHS) criteria. The USPHS system is primarily for posterior teeth, so a new system was developed for anterior teeth. The definitions and criteria for the rating system are detailed in Table (1). Briefly, it was a photographic examination including an evaluation of the color, shape, and integrity of the strip crown.
All patients were recalled, and restorations were evaluated for anatomic form, surface texture, recurrent caries, color match and retention in accordance with Ryge's Direct (US Public Health Service) evaluation criteria at baseline (immediately postoperative), and intervals of 6, 12, 24, and 36 months.
The crown was considered to be clinically successful, if the surface appeared smooth, the colour remained good or acceptable, without chipping/ fracture or recurrent caries at tooth/restoration interface and there is no loss of the restoration.
Data are analyzed using percentages, frequencies and cumulative frequencies. The Z-test will be used for comparison between failure rates of the two types of failures (Failure due to trauma \& failure of bonding), significance level is set at P< 0·05. The Chi squared test will be used for association between the number of affected surfaces and the total failures. The level of significance (P-value) is set at P< 0·05.
- Being tested
- Treatment by composite coronal build-up
- Keywords
- Child, Esthetics, Dental caries, Primary incisors, Composite
- Medical subject headings
- Dental Caries, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment by composite coronal build-upOther
A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth.
| Study group | Role | What they receive |
|---|---|---|
| Single arm : Composite coronal build up strip crown | Experimental | A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth. Receives: Other: Treatment by composite coronal build-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the clinical performance of composite strip crowns.
Evaluation of the clinical performance of composite strip crowns. By Clinical photographs.
Measured: 36 months
Secondary outcomes (1)
Assessment of success and failure of the composite coronal build-up after 3 years follow-up.
Assessment of success and failure of the composite coronal build-up after 3 years follow-up in terms of:
- Retention
- Color match
- Recurrent Caries
- Fracture/Chipping
- Loss of restoration (Failure)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study startJun 2016
- Primary completionJun 2017
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Associate Professor Dr. Rania Abdallah Nasr, Cairo University
- Investigators
- Rania Nasr, Assoc. Prof., Principal investigator, Faculty of Dentistry, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758221
- Sponsor's protocol ID
- 41720
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of any private data of participants with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: Prospective Single Arm Study
- ClinicalTrials.gov ID
- NCT04758221
- Acronym / sponsor ID
- 41720
- Keywords
- Child, Esthetics, Dental caries, Primary incisors, Composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 17 Feb 2021 (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.
Prospective single arm study was to evaluate the clinical success and/ or failure of resin-bonded composite coronal build-up retained by macro-retentive grooves for restoring mutilated primary maxillary incisors after 36 months.
Design: Forty two primary incisors out of 14 children, aged 2-5years, treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6, 12, 18, 24 and 36 months included in the study. The parameters recorded at the baseline and at the follow-up intervals were: retention, colour match, the number and location of the decayed surfaces (recurrent caries), chipping /fracture of the restoration and loss of restoration (failure).
Materials and Methods: A total of (14) pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study. A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micro-mechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth. The patients returned at the end of 6, 12, 18, 24 and 36 months and received clinical examinations. Another dentist (co-author) who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service (USPHS) criteria.
Detailed description
Purpose: The purpose of this study was to evaluate the clinical success and/ or failure of resin-bonded composite coronal build-up retained by macro-retentive grooves for restoring mutilated primary maxillary incisors after 36 months.
Design: Forty two primary incisors out of 14 children, aged 2-5years, treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6, 12, 18, 24 and 36 months included in the study. The parameters recorded at the baseline and at the follow-up intervals were: retention, colour match, the number and location of the decayed surfaces (recurrent caries), chipping /fracture of the restoration and loss of restoration (failure).
Materials and Methods: A total of (14) pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study. A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth. The patients returned at the end of 6, 12, 18, 24 and 36 months and received clinical examinations. Another dentist (co-author) who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service (USPHS) criteria. The USPHS system is primarily for posterior teeth, so a new system was developed for anterior teeth. The definitions and criteria for the rating system are detailed in Table (1). Briefly, it was a photographic examination including an evaluation of the color, shape, and integrity of the strip crown.
All patients were recalled, and restorations were evaluated for anatomic form, surface texture, recurrent caries, color match and retention in accordance with Ryge's Direct (US Public Health Service) evaluation criteria at baseline (immediately postoperative), and intervals of 6, 12, 24, and 36 months.
The crown was considered to be clinically successful, if the surface appeared smooth, the colour remained good or acceptable, without chipping/ fracture or recurrent caries at tooth/restoration interface and there is no loss of the restoration.
Data are analyzed using percentages, frequencies and cumulative frequencies. The Z-test will be used for comparison between failure rates of the two types of failures (Failure due to trauma \& failure of bonding), significance level is set at P< 0·05. The Chi squared test will be used for association between the number of affected surfaces and the total failures. The level of significance (P-value) is set at P< 0·05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm : Composite coronal build up strip crown | Experimental | Other: Treatment by composite coronal build-upA total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Only children in the age group of 2-5 years.
Key exclusion criteria (3 listed)
- • Any tooth nearing exfoliation or not fit for restoration.
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 |
|---|---|---|
| Treatment by composite coronal build-upA total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth. | Other | Single arm : Composite coronal build up strip crown |
Primary outcome
Evaluation of the clinical performance of composite strip crowns.
Time frame: 36 months
Evaluation of the clinical performance of composite strip crowns. By Clinical photographs.
1 secondary outcome
Assessment of success and failure of the composite coronal build-up after 3 years follow-up.
Time frame: 36 months
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 17 Feb 2021.
- Individual participant dataSharing planned: No. No sharing of any private data of participants 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.
Rania Nasr, Assoc. Prof. principal investigator
Faculty of Dentistry, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment by composite coronal build-up in people with Early Childhood Caries and Pediatric Disease, run by Cairo 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 2 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 17 Feb 2021. 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?
Evaluation of the clinical performance of composite strip crowns. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2021.