Primary TeethRCTNCT06478004

Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates

A study testing Direct composite restoration of carious primary anterior teeth using custom 3D printed templates and Direct composite restoration of carious primary anterior teeth using conventional strip crowns in people with Primary Teeth, run by Minia University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 5 years
Conditions the study is for: Primary Teeth
What is being tested?: Direct composite restoration of carious primary anterior teeth using custom 3D printed templates and Direct composite restoration of carious primary anterior teeth using conventional strip crowns
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteEgypt
Study dates: 15 Feb 2023to 15 Apr 2024
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 3 to 5 years
All sexes
No healthy volunteers
Child

Who may be able to join

Presence of at least two vital carious primary maxillary incisors.
Teeth had at least two carious surfaces requiring complete coronal restoration.

Who cannot join

Children with malocclusion or parafunctional oral habits
Teeth beyond restoration.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Minia University
Minya

Other trials in Egypt

About this study

Official title: Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates: A 12-Month Parallel Randomized Controlled Clinical Trial

Esthetic restoration of primary anterior teeth is challenging. Aim of the study: Evaluation of the 12-month clinical performance of direct resin composite restoration of carious vital primary anterior teeth using custom 3D printed templates compared to conventional strip crowns. Subjects and methods: A parallel arms randomized controlled clinical trial was performed in which 98 carious vital primary anterior teeth in 32 children were directly restored with resin composite either with the help of custom 3D printed templates (Group: A) or strip crowns (Group: B). Restorations were assessed for surface luster, anatomical form, material fracture, marginal adaptation, and periodontal response using the revised FDI criteria on three occasions; a week after placement (T0), after six months (T1), and after twelve months (T2). Comparisons between groups were evaluated. A statistically significant level was considered when p value less than or equal 0.05. The tooth was the unit of analysis.

Read the detailed description

The present study is a single-center randomized controlled clinical trial with 1:1 allocation ratio. This trial entailed directly restoring carious primary anterior teeth with resin composite either with the help of custom 3D printed templates obtained from digitally waxed-up patients' dental models (Group: A) or conventional strip crowns (Group: B). Restorations were assessed for clinical performance on three occasions; postoperatively (T0), after six months (T1), and after twelve months (T2).

Conditions: Primary Teeth
Being tested: Direct composite restoration of carious primary anterior teeth using custom 3D printed templates, Direct composite restoration of carious primary anterior teeth using conventional strip crowns
Keywords: Early childhood caries, Strip Crown, 3D Printing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Direct composite restoration of carious primary anterior teeth using custom 3D printed templatesOther
A patient dental model is acquired by digital scan then digital waxing-up is performed using the Exocad software to 3D print clear templates for direct composite resin restoration.
Direct composite restoration of carious primary anterior teeth using conventional strip crownsOther
Direct composite resin restoration using celluloid crown forms

Study groups in NCT06478004
Study group	Role	What they receive
Direct resin composite with the help of custom 3D printed templates	Experimental	Directly restoring carious primary anterior teeth with resin composite with the help of custom 3D printed templates obtained from digitally waxed-up patients' dental models. Receives: Other: Direct composite restoration of carious primary anterior teeth using custom 3D printed templates
Direct resin composite using conventional strip crowns.	Active comparator	Directly restoring carious primary anterior teeth with resin composite using conventional strip crowns. Receives: Other: Direct composite restoration of carious primary anterior teeth using conventional strip crowns

What is being measured

The primary outcome is the main question the study is designed to answer.

Surface luster
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Measured: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Anatomical form
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Measured: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Material fracture
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Measured: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Marginal adaptation
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Measured: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Periodontal response
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Measured: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202315 Apr 2024

First posted27 Jun 2024
Study start15 Feb 2023
Primary completion1 Apr 2024
Study completion15 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary TeethStudies of the same condition, open and under way.
More trials run by Minia 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
Model description: Single-center, prospective randomized controlled clinical trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06478004
Sponsor's protocol ID: #841/2023
Acronym: RCT
Status last verified: Jun 2024
First submitted: 15 Jun 2024
Last updated: 1 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates: A 12-Month Parallel Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT06478004
Acronym / sponsor ID: RCT / #841/2023
Conditions: Primary Teeth
Keywords: Early childhood caries, Strip Crown, 3D Printing
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Minia UniversityUniversity, hospital or other
Study start: 15 Feb 2023 (actual)
Primary completion: 1 Apr 2024 (actual)
Study completion: 15 Apr 2024 (actual)
First posted: 27 Jun 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Single-center, prospective randomized controlled clinical trial

Arm	Type	Receives
Direct resin composite with the help of custom 3D printed templates	Experimental	Other: Direct composite restoration of carious primary anterior teeth using custom 3D printed templatesDirectly restoring carious primary anterior teeth with resin composite with the help of custom 3D printed templates obtained from digitally waxed-up patients' dental models.
Direct resin composite using conventional strip crowns.	Active comparator	Other: Direct composite restoration of carious primary anterior teeth using conventional strip crownsDirectly restoring carious primary anterior teeth with resin composite using conventional strip crowns.

Who may qualify

Ages: 3 to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Presence of at least two vital carious primary maxillary incisors.
Teeth had at least two carious surfaces requiring complete coronal restoration.

Key exclusion criteria (2 listed)

Children with malocclusion or parafunctional oral habits
Teeth beyond 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
Direct composite restoration of carious primary anterior teeth using custom 3D printed templatesA patient dental model is acquired by digital scan then digital waxing-up is performed using the Exocad software to 3D print clear templates for direct composite resin restoration.	Other	Direct resin composite with the help of custom 3D printed templates
Direct composite restoration of carious primary anterior teeth using conventional strip crownsDirect composite resin restoration using celluloid crown forms	Other	Direct resin composite using conventional strip crowns.

Primary outcome

Surface luster
Time frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Anatomical form
Time frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Material fracture
Time frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Marginal adaptation
Time frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)
Periodontal response
Time frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)

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 1 Jul 2024.

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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.

Mina Yassa, Doctor principal investigator

Faculty of Dentistry, Minia University, Minia, Egypt.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 1 Jul 2024. 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?

Surface luster (time frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)). The study lists 5 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 NCT06478004.

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 1 Jul 2024.