Carious TeethNCT06161103
Comparison of 3D Printed Composite Resin Crowns With Stainless Steel Crowns
A study testing 3D Printed Prefabricated Composite Resin Crown Group and Prefabricated stainless steel crown group in people with Carious Teeth, run by Marmara University.
Trial summary
The goal of this splith - mouth clinical trial is to compare 3D Printed Prefabric Composite Resin Crowns with Stainless Steel Crowns in healthy 50 children age between 5 and 9 with caries on more than one surface of the primary second molars. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Teeth
- What is being tested?
- 3D Printed Prefabricated Composite Resin Crown Group and Prefabricated stainless steel crown group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2023to 1 Jun 2026
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 5-9 years with caries on second primary molars
- Children without systemic disease or developmental dental anomalies that may affect caries susceptibility.
- Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962).
- Those with deep dentin caries that do not extend to the pulp in the teeth to be treated
- The molars will be treated with a crown indication.
- Presence of symmetry of the primary molar to be treated in the opposite arch.
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- The molar to be treated is in occlusion with the antagonist.
- Presence of caries on at least two surfaces of the molars to be treated.
- Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated
- Patients whose parents and themselves agree to participate in the treatment
Who cannot join
- Children whose treatment cannot be continued on the dental chair due to cooperation
- Molars that will soon be exfoliated, 1/2 of the root has been resorbed
- The presence of bruxism
- The presence of erosion or attrition-related wear on the opposing molar
- The patient does not come to the control appointment or does not want to continue to the research
- Have allergy to local anesthetic, nickel or chromium
- Complications during treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Clinical Success of 3D Printed Prefabricated Composite Resin Crowns With Stainless Steel Crowns: A Randomised Controlled Trial
The goal of this splith - mouth clinical trial is to compare 3D Printed Prefabric Composite Resin Crowns with Stainless Steel Crowns in healthy 50 children age between 5 and 9 with caries on more than one surface of the primary second molars.
The main question[s] it aims to answer are:
- 3D printed composite resin crown's survival rate is as succesful as stainless steel crowns
- 3D printed composite resin crowns periodontal integrity is as succesful as stainless steel crowns
Condition or disease : Carious Teeth
Intervention/treatment:
Procedure/Surgery: 3D Printed Prefabricated composite resin crown group Procedure/Surgery: Prefabricated stainless steel crown group
Read the detailed description
In this study, 3D Printed prefabricated composite resin crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.
- Conditions
- Carious Teeth
- Being tested
- 3D Printed Prefabricated Composite Resin Crown Group, Prefabricated stainless steel crown group
- Keywords
- 3D printing, stainless steel crowns, composite resin crowns
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Prefabricated Composite Resin Crown GroupProcedure or surgery
3D Crown application: After preparing the molars, the crown was cemented by passive seating with modified glass ionomer cement (GC FujiCEM Evolve, GC America, Alsip, USA).
Prefabricated stainless steel crown groupProcedure or surgery
Stainless steel crown application: After preparing the molars, the crown was filled with type-1 glass ionomer cement (Aqua Meron, Voco, Cuxhaven, Germany) and cemented.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 3D Printed Prefabricated Composite Resin Crown group | Experimental | (Custom Composite Resin (Custom Resin Solutions, CRSCAM TEKNOLOJİ AŞ., ANTALYA, TURKEY) Receives: Procedure: 3D Printed Prefabricated Composite Resin Crown Group |
| Active Comparator: Prefabricated stainless steel crown group | Experimental | Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea) Receives: Procedure: Prefabricated stainless steel crown group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical success
According to the criteria reported by Santamaria et al. (2004), clinical success will be categorized as successful, major failure, and minor failure.
Successful:
No clinical signs or symptoms of pulp pathology Tooth has exfoliated (without any minor/major failures) No deformations in the crown/restoration No pathology observed in radiographs
Minor failure:
Reversible pulpitis (No need for root canal treatment or extraction) Crown/restoration loss that can be restored Presence of deformations/fractures/perforations in the crown/restoration Permanent crown remaining submerged Presence of new caries at the margins
Major failure:
Irreversible pulpitis Crown/restoration loss that cannot be restored Inter-radicular radiolucency Internal root resorption
Measured: 24 Month
United States Public Health Service (USPHS): Retention, marginal compliance and gingival health criteria
Restorations were evaluated to determine success according to modified United States Public Health Service (USPHS) criteria for marginal adaptation, marginal discolouration, secondary caries, anatomical form, retention, postoperative sensitivity and colour matching. Restorations with an "Alpha (A)" score were considered successful, those with a "Bravo (B)" score were considered acceptable, and those with a "Charlie (C)" score were considered unsuccessful. The scoring of the restorations was decided by agreement of both dentists (Ryge G. et al., 1980).
Measured: 24 Month
Marginal Crown Gap
(0) ¼ at the gingival margin, (1) ¼ below the gingival line (apical to the gingival margin) or (2) ¼ above the gingival line (occlusal to the gingival margin) [Muhamed Altinawia et al., 1980].
Measured: 24 Month
Plaque Index (PI) (Silness and Loe, 1964)
In this index, the thickness of dental plaque on the mesial, distal, vestibular, lingual tooth surfaces of all teeth or selected teeth and in relation to the gingiva is evaluated by probing. The values determined on the surfaces are summed and the plaque index value of the individual is obtained by taking the mathematical average.
0-No plaque in the area adjacent to the gingiva
- There is a thin film on the edge of the gingival margin. This formation can only be detected with the help of a probe.
- There is plaque in the gingival pocket and gingival margin at a level that can be determined by eye. There is no plaque in the aproximal area.
- A large amount of plaque layer is observed in the gingival pocket and gingival margin. Interdental areas are filled with plaque.
Measured: 24 Month
Gingival Index (GI) (Löe & Silness, 1963)
It evaluates bleeding, which is the most basic sign of inflammation. The mesial, distal, vestibule and lingual sides of the teeth are evaluated. These values are then summed and divided by four.
0- Healthy gingiva, no inflammation
- Mild inflammation, discolouration and mild oedema of the gums, no bleeding on probing
- Moderate inflammation, redness and oedema of the gums, bleeding on probing
- There is advanced inflammation, redness, oedema in the gum, spontaneous bleeding is observed.
Measured: 24 Month
Simplified Oral Hygiene Index (OHI-S)
Simplified Oral Hygiene Index (OHI-S) will be used to evaluate the plaque and calculus deposits of the patient and control groups. In this index, in order to simplify the oral hygiene index, six index teeth, which are considered representative of all anterior and posterior teeth, are evaluated. These teeth are teeth numbered 16, 26, 11, 31, 36, 46. The facial surfaces of teeth 16-26-11-31 and the lingual surfaces of teeth 36-46 are evaluated. This facilitation process is used both in the calculation of the debris index and in the calculation of the calculus index. After calculating the debris and calculus assessment indices, a simplified oral hygiene index is obtained (REF: 29.Greene, J.C., Vermillion, J.R.: The Simplified Oral Hygiene Index, J. Amer. Dent. Ass 68 : 7, 1960).
The Simplified Oral Hygiene Index (OHI-S) Debris Index 0- No debris.
- There is debris less than 1/3 of the tooth surface.
- There is debris more than 1/3 and less than 2/3 of the tooth surface.
- More
Measured: 24 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start30 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious TeethStudies of the same condition, open and under way.
- More trials run by Marmara 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161103
- Sponsor's protocol ID
- MUPediatricDentistry 3D Crown
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Success of 3D Printed Prefabricated Composite Resin Crowns With Stainless Steel Crowns: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06161103
- Acronym / sponsor ID
- MUPediatricDentistry 3D Crown
- Conditions
- Carious Teeth
- Keywords
- 3D printing, stainless steel crowns, composite resin crowns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Dec 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.
The goal of this splith - mouth clinical trial is to compare 3D Printed Prefabric Composite Resin Crowns with Stainless Steel Crowns in healthy 50 children age between 5 and 9 with caries on more than one surface of the primary second molars.
The main question[s] it aims to answer are:
- 3D printed composite resin crown's survival rate is as succesful as stainless steel crowns
- 3D printed composite resin crowns periodontal integrity is as succesful as stainless steel crowns
Condition or disease : Carious Teeth
Intervention/treatment:
Procedure/Surgery: 3D Printed Prefabricated composite resin crown group Procedure/Surgery: Prefabricated stainless steel crown group
Detailed description
In this study, 3D Printed prefabricated composite resin crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 3D Printed Prefabricated Composite Resin Crown group | Experimental | Procedure: 3D Printed Prefabricated Composite Resin Crown Group(Custom Composite Resin (Custom Resin Solutions, CRSCAM TEKNOLOJİ AŞ., ANTALYA, TURKEY) |
| Active Comparator: Prefabricated stainless steel crown group | Experimental | Procedure: Prefabricated stainless steel crown groupStainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea) |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Healthy children aged 5-9 years with caries on second primary molars
- Children without systemic disease or developmental dental anomalies that may affect caries susceptibility.
- Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962).
- Those with deep dentin caries that do not extend to the pulp in the teeth to be treated
- The molars will be treated with a crown indication.
Key exclusion criteria (7 listed)
- Children whose treatment cannot be continued on the dental chair due to cooperation
- Molars that will soon be exfoliated, 1/2 of the root has been resorbed
- The presence of bruxism
- The presence of erosion or attrition-related wear on the opposing molar
- The patient does not come to the control appointment or does not want to continue to the research
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 |
|---|---|---|
| 3D Printed Prefabricated Composite Resin Crown Group3D Crown application: After preparing the molars, the crown was cemented by passive seating with modified glass ionomer cement (GC FujiCEM Evolve, GC America, Alsip, USA). | Procedure or surgery | Experimental: 3D Printed Prefabricated Composite Resin Crown group |
| Prefabricated stainless steel crown groupStainless steel crown application: After preparing the molars, the crown was filled with type-1 glass ionomer cement (Aqua Meron, Voco, Cuxhaven, Germany) and cemented. | Procedure or surgery | Active Comparator: Prefabricated stainless steel crown group |
Primary outcome
Comparison of clinical success
Time frame: 24 Month
According to the criteria reported by Santamaria et al. (2004), clinical success will be categorized as successful, major failure, and minor failure. Successful: No clinical signs or symptoms of pulp pathology Tooth has exfoliated (without any minor/major failures) No deformations in the crown/restoration No pathology observed in radiographs Minor failure: Reversible pulpitis (No need for root canal treatment or extraction) Crown/restoration loss that can be restored Presence of deformations/fractures/perforations in the crown/restoration Permanent crown remaining submerged Presence of new caries at the margins Major failure: Irreversible pulpitis Crown/restoration loss that cannot be restored Inter-radicular radiolucency Internal root resorption
United States Public Health Service (USPHS): Retention, marginal compliance and gingival health criteria
Time frame: 24 Month
Restorations were evaluated to determine success according to modified United States Public Health Service (USPHS) criteria for marginal adaptation, marginal discolouration, secondary caries, anatomical form, retention, postoperative sensitivity and colour matching. Restorations with an "Alpha (A)" score were considered successful, those with a "Bravo (B)" score were considered acceptable, and those with a "Charlie (C)" score were considered unsuccessful. The scoring of the restorations was decided by agreement of both dentists (Ryge G. et al., 1980).
Marginal Crown Gap
Time frame: 24 Month
(0) ¼ at the gingival margin, (1) ¼ below the gingival line (apical to the gingival margin) or (2) ¼ above the gingival line (occlusal to the gingival margin) [Muhamed Altinawia et al., 1980].
Plaque Index (PI) (Silness and Loe, 1964)
Time frame: 24 Month
In this index, the thickness of dental plaque on the mesial, distal, vestibular, lingual tooth surfaces of all teeth or selected teeth and in relation to the gingiva is evaluated by probing. The values determined on the surfaces are summed and the plaque index value of the individual is obtained by taking the mathematical average. 0-No plaque in the area adjacent to the gingiva 1. There is a thin film on the edge of the gingival margin. This formation can only be detected with the help of a probe. 2. There is plaque in the gingival pocket and gingival margin at a level that can be determined by eye. There is no plaque in the aproximal area. 3. A large amount of plaque layer is observed in the gingival pocket and gingival margin. Interdental areas are filled with plaque.
Gingival Index (GI) (Löe & Silness, 1963)
Time frame: 24 Month
It evaluates bleeding, which is the most basic sign of inflammation. The mesial, distal, vestibule and lingual sides of the teeth are evaluated. These values are then summed and divided by four. 0- Healthy gingiva, no inflammation 1. Mild inflammation, discolouration and mild oedema of the gums, no bleeding on probing 2. Moderate inflammation, redness and oedema of the gums, bleeding on probing 3. There is advanced inflammation, redness, oedema in the gum, spontaneous bleeding is observed.
Simplified Oral Hygiene Index (OHI-S)
Time frame: 24 Month
Simplified Oral Hygiene Index (OHI-S) will be used to evaluate the plaque and calculus deposits of the patient and control groups. In this index, in order to simplify the oral hygiene index, six index teeth, which are considered representative of all anterior and posterior teeth, are evaluated. These teeth are teeth numbered 16, 26, 11, 31, 36, 46. The facial surfaces of teeth 16-26-11-31 and the lingual surfaces of teeth 36-46 are evaluated. This facilitation process is used both in the calculation of the debris index and in the calculation of the calculus index. After calculating the debris and calculus assessment indices, a simplified oral hygiene index is obtained (REF: 29.Greene, J.C., Vermillion, J.R.: The Simplified Oral Hygiene Index, J. Amer. Dent. Ass 68 : 7, 1960). The Simplified Oral Hygiene Index (OHI-S) Debris Index 0- No debris. 1. There is debris less than 1/3 of the tooth surface. 2. There is debris more than 1/3 and less than 2/3 of the tooth surface. 3. More
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Printed Prefabricated Composite Resin Crown Group and Prefabricated stainless steel crown group in people with Carious Teeth, run by Marmara University.
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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Betül Şen Yavuz, DDS (+905399887646, dtbetulsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of clinical success (time frame: 24 Month). The study lists 6 primary outcomes in all. 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 7 Dec 2023.