Dental CariesNCT06685640
Comparison of Clinical Success of Stainless Steel Crowns and Zirconia Crowns in Primary Molars
A study testing prefabricated stainless steel crowns and prefabricated zirconia crowns in people with Dental Caries and Pulpotomy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Evaluation and understanding of clinical success, parental satisfaction and effects on periodontal tissues are the main expected benefits of prefabricated zirconia crowns and prefabricated stainless steel crowns. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Pulpotomy
- What is being tested?
- prefabricated stainless steel crowns and prefabricated zirconia crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age range of children from 4 to 5 years.
- Systemically healthy.
- Children who are positive and extremely positive according to the Frankl behavior scale.
- Asymptomatic primary mandibular second molars with multi-surface deep caries requiring pulpotomy treatment.
- No history of spontaneous pain.
- Primary mandibular second molars where bleeding at the pulpotomy site can be controlled within 3 to 5 minutes.
Show all 10Show fewer
- Having opposing teeth in occlusal contact.
- Patients without any periodontal-related attachment loss.
- Patients without abscesses or fistulas on primary second molars.
- Children who verbally and in writing agree to participate in the study and are willing to attend regular follow-up appointments will be included.
Who cannot join
- Having a systemic disease.
- Periapical infection, abscess, or mobility in primary second molars.
- Those with active periodontal disease.
- Malocclusion or missing opposing tooth.
- Primary second molars with pathological internal or external resorption.
- Physiological root resorption exceeding 1/3 of the root.
- Children with bruxism or unilateral chewing habits will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adnan Menderes University
Aydin, Aydın, 09100
Kadriye Görkem Ulu Güzel, +90 505 764 63 72, gorkem.ulu@adu.edu.tr
Şerifenur Yetiş, +90 554 175 31 75, dt.serifenuryetis@gmail.com
About this study
Official title: Evaluation of Clinical Success and Parental Satisfaction of Prefabricated Stainless Steel Crowns and Zirconia Crowns Applied to Primary Molar Teeth
Evaluation and understanding of clinical success, parental satisfaction and effects on periodontal tissues are the main expected benefits of prefabricated zirconia crowns and prefabricated stainless steel crowns. For a long time, stainless steel crowns have been the restorative material of choice for children's primary and permanent posterior teeth. Today, prefabricated zirconia crowns are more popular than other options because they meet aesthetic expectations and have high mechanical strength. The aim of this study is to evaluate and compare the periodontal health, plaque accumulation, opposing tooth wear, parental satisfaction, and clinical performance (color match, retention, marginal integrity, marginal discoloration, anatomic form, secondary caries, surface roughness, surface gloss and postoperative sensitivity) of pediatric prefabricated stainless steel and zirconia crowns applied after pulpotomy to asymptomatic, multifaceted, deep carious primary mandibular second molars.
Read the detailed description
MATERIALS AND METHODS/RESEARCH TECHNIQUES:
Material:
In the study, two different prefabricated crowns will be applied to the right and left primary mandibular second molars after pulpotomy using a split-mouth design. One will be a prefabricated zirconia crown and the other will be a prefabricated stainless steel crown. The sample size was calculated by G*Power analysis program as 12 teeth, 6 teeth in each group. Since this sample size would reduce the validity and reliability of future statistical tests, it was decided to conduct the study with a total of 20 samples, 10 in each group, taking into account possible data loss and the power of the study. Teeth will be randomly divided into two groups according to crown type.
The study will be terminated when the last visit of the last patient providing the sample is completed and the data is finalized.
Method:
- Before the treatment of primary mandibular second molars that meet the inclusion criteria, topical anesthesia (Vemcaine Pump Spray, VEM İlaç, Turkey) containing 10% lidocaine will be applied to the anesthesia area with a cotton pellet. After topical anesthesia, local anesthesia (Maxicaine Ampoule, VEM İlaç, Turkey) containing 40 mg articaine hydrochloride and 0.006 mg epinephrine hydrochloride in 1 ml will be administered.
- Then, the area will be cleaned under rubber dam isolation, and the coronal pulp will be removed. Hemostasis will be provided with a sterile cotton pellet moistened with serum for 5 minutes, and hemostasis will be achieved with ferric sulfate (ViscoStat™, Ultradent, Germany) for 15 seconds.
- The pulp chamber will be filled with MTA (NeoMTA Putty, NuSmile, TX, USA), then a 0.5 mm layer of resin-modified glass ionomer will be applied to the cavity floor, and the restoration will be completed with composite.
- The first step in applying stainless steel crowns will be to select the crown length. First, high-speed rotary tools will be used to prepare 1.5-2 mm occlusal reduction with diamond burs; a 1-2 mm subgingival preparation will be made from the gingival margin. The proximal surfaces will be reduced approximately 1 mm thick, starting from the occlusal and buccally, lingually, and gingivally from the mesial and distal contact points of the tooth.
- In order to achieve full adaptation to the tooth, after any necessary corrections, the crown edge will be curved with the help of forceps, and the edge will be trimmed with scissors or a bur until cervical adaptation is achieved. The shortened crown edges will be polished with the help of discs and rubbers.
- The teeth to be coated with zirconium will be prepared subgingivally from 2 mm occlusal and 1-2 mm from the gingival margin in accordance with the manufacturer's instructions.
- Since zirconia crowns are not flexible, the mesial and distal walls will be prepared parallel to the adjacent teeth, taking into account the distance to ensure passive adaptation.
- A conical diamond bur will be used in proximal reduction to ensure passive seating of the selected crown. The appropriate size crown will be found by trial.
- After the appropriate crown is selected for zirconia crowns, a cotton pellet moistened with sterile serum is applied to the area for 5 minutes to control bleeding, and the bleeding will be stopped. If necessary, bleeding control agents or retraction cords will be used to prevent active bleeding during cementation.
- The crowns in both groups are cemented with FujiCEM Evolve (GC, Tokyo, Japan). This cement in the RMCIS group is in paste form. It is applied directly into the crown in an injectable form with its own special tip and polymerized with a light device for 10 seconds. The cement residue accumulated at the gingival margin is cleaned with a probe, and a setting time of 4-5 minutes is waited in accordance with the manufacturer's instructions. Occlusion is checked. After the cementation is completed with the appropriate application technique, the cement residue accumulated at the gingival margin is cleaned with a probe tip. If a scratch occurs on the crowns during this process, this mark is cleaned with a bur, and the surface is polished with polishing discs.
In general, in the evaluation of success:
- Teeth that have been extracted due to abscess development in control appointments.
- Dissolution of cement and decementation of the crown.
- Internal and external root resorption seen in radiographic evaluation.
- Teeth with lesions in the furcation region.
- Teeth with widening in the periodontal ligament space will be evaluated as unsuccessful.
Plaque Index and Gingival Index in pediatric prefabricated stainless steel and zirconia crowns applied to asymptomatic primary mandibular second molars after pulpotomy will be evaluated at baseline and at the 1-month, 3-month, 6-month, and 12-month follow-ups. Tooth Wear Index, Modified United States Public Health Service (USPHS) Criteria, and parental satisfaction will also be assessed at the 1-month, 3-month, 6-month and 12-month follow-ups. Intraoral photographs will be taken immediately after treatment and at each follow-up appointment.
- Conditions
- Dental Caries, Pulpotomy
- Being tested
- prefabricated stainless steel crowns, prefabricated zirconia crowns
- Keywords
- primary molars, stainless steel crowns, zirconia
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prefabricated stainless steel crownsOther
Full coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy
prefabricated zirconia crownsOther
Full coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| prefabricated stainless steel crowns (Group A) | Experimental | Groups that received prefabricated stainless steel crowns Receives: Other: prefabricated stainless steel crowns |
| Prefabricated zirconia crowns (Group B) | Experimental | Groups that received prefabricated zirconia crowns Receives: Other: prefabricated zirconia crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periodontal health (Gingiva)
Gingival evaluation of the patients will be made according to the Loe and Silness Gingival Index.
According to this index system:
0 : Normal (absence of inflammation)
- : Mild gingivitis (slight change in color, slight edema; no bleeding on probing)
- : Moderate gingivitis (redness, edema, and glazing; bleeding on probing)
- : Severe gingivitis (marked redness and edema; ulceration; tendency to spontaneous bleeding)
Measured: baseline, 1 months, 3 months, 6 months, 12 months
Change in periodontal health (Plaque)
Plaque evaluation of the patients will be performed according to Silness and Loe Plaque Index. After the teeth isolated with cotton before the evaluation are air dried, the amount of plaque in the area near the gingival margin of each tooth will be examined by inspection and examination probe.
According to this index system::
0: No plaque.
- A thin layer of plaque is visible along the gingival margin. This thin layer can be detected with the examination probe.
- A moderate layer of plaque is visible along the gingival margin. This plaque can be visually detected.
- Heavy plaque accumulation is detected at the gingival margin and in the interdental area.
Measured: baseline, 1 months, 3 months, 6 months, 12 months
Wear of opposing natural teeth
The Smith and Knight Tooth Wear Index classification, which is used to grade tooth wear, will be applied. The Smith and Knight Tooth Wear Index criteria are as follows: 0 Points (Buccal/lingual/occlusal/incisal): No loss of enamel surface characteristics (Cervical): No contour loss. Score 1 (Buccal/lingual/occlusal/incisal): Loss of enamel surface features (cervical): Minimal contour loss. Score 2 (Buccal/lingual/occlusal): Dentin opening with enamel loss of less than 1/3 of the surface (incisal): Dentin exposure with enamel loss (cervical): Less than 1 mm defect. Score 3 (Buccal/lingual/occlusal): More than 1/3 of the dentin surface exposed with enamel loss (incisal): Enamel loss and significant dentin loss (cervical): 1-2 mm defect. Score 4 (Buccal/lingual/occlusal): Complete loss of enamel or exposure of pulp/secondary dentin (incisal): Opening of pulp or secondary dentin (cervical): Defect larger than 2 mm or pulp/secondary dentin dehiscence.
Measured: 1 months, 3 months, 6 months, 12 months
Change in clinical performance
Modified United States Public Health Service (USPHS) criteria will be used to evaluate color match, retention, marginal integrity, marginal discoloration, anatomic form, secondary caries, surface roughness, surface gloss and postoperative sensitivity. Restorations are evaluated and scored alphabetically. When evaluated in terms of any criterion; A: ideal restorations, B: restorations that are not ideal but within acceptable limits, C: restorations that are clinically unacceptable and need to be replaced, D: restorations that are already mobile or damage tissues receive a score of D. During clinical examination and recording, phonetically similar nomenclature is used to avoid misunderstanding of the score in terms of the letter pronounced by the physician: 'A'lfa, 'B'ravo, 'C'harlie, 'D'elta.
Measured: 1 months, 3 months, 6 months, 12 months
Secondary outcomes (1)
Measuring of parental satisfaction
Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction.
- very dissatisfied
- dissatisfied
- neutrally satisfied
- satisfied
- very satisfied.
Measured: 1 months, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start30 Jul 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadriye Görkem Ulu Güzel, Aydin Adnan Menderes University
- Investigators
- Kadriye Görkem Ulu Güzel, Doç. Prof., Study director, Adnan Menderes Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685640
- Sponsor's protocol ID
- AADÜDHF 2023/36
- Status last verified
- Dec 2025
- First submitted
- 11 Nov 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient Data (IPD) will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Success and Parental Satisfaction of Prefabricated Stainless Steel Crowns and Zirconia Crowns Applied to Primary Molar Teeth
- ClinicalTrials.gov ID
- NCT06685640
- Acronym / sponsor ID
- AADÜDHF 2023/36
- Conditions
- Dental Caries, Pulpotomy
- Keywords
- primary molars, stainless steel crowns, zirconia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 12 Nov 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.
Evaluation and understanding of clinical success, parental satisfaction and effects on periodontal tissues are the main expected benefits of prefabricated zirconia crowns and prefabricated stainless steel crowns. For a long time, stainless steel crowns have been the restorative material of choice for children's primary and permanent posterior teeth. Today, prefabricated zirconia crowns are more popular than other options because they meet aesthetic expectations and have high mechanical strength. The aim of this study is to evaluate and compare the periodontal health, plaque accumulation, opposing tooth wear, parental satisfaction, and clinical performance (color match, retention, marginal integrity, marginal discoloration, anatomic form, secondary caries, surface roughness, surface gloss and postoperative sensitivity) of pediatric prefabricated stainless steel and zirconia crowns applied after pulpotomy to asymptomatic, multifaceted, deep carious primary mandibular second molars.
Detailed description
MATERIALS AND METHODS/RESEARCH TECHNIQUES:
Material:
In the study, two different prefabricated crowns will be applied to the right and left primary mandibular second molars after pulpotomy using a split-mouth design. One will be a prefabricated zirconia crown and the other will be a prefabricated stainless steel crown. The sample size was calculated by G*Power analysis program as 12 teeth, 6 teeth in each group. Since this sample size would reduce the validity and reliability of future statistical tests, it was decided to conduct the study with a total of 20 samples, 10 in each group, taking into account possible data loss and the power of the study. Teeth will be randomly divided into two groups according to crown type.
The study will be terminated when the last visit of the last patient providing the sample is completed and the data is finalized.
Method:
- Before the treatment of primary mandibular second molars that meet the inclusion criteria, topical anesthesia (Vemcaine Pump Spray, VEM İlaç, Turkey) containing 10% lidocaine will be applied to the anesthesia area with a cotton pellet. After topical anesthesia, local anesthesia (Maxicaine Ampoule, VEM İlaç, Turkey) containing 40 mg articaine hydrochloride and 0.006 mg epinephrine hydrochloride in 1 ml will be administered.
- Then, the area will be cleaned under rubber dam isolation, and the coronal pulp will be removed. Hemostasis will be provided with a sterile cotton pellet moistened with serum for 5 minutes, and hemostasis will be achieved with ferric sulfate (ViscoStat™, Ultradent, Germany) for 15 seconds.
- The pulp chamber will be filled with MTA (NeoMTA Putty, NuSmile, TX, USA), then a 0.5 mm layer of resin-modified glass ionomer will be applied to the cavity floor, and the restoration will be completed with composite.
- The first step in applying stainless steel crowns will be to select the crown length. First, high-speed rotary tools will be used to prepare 1.5-2 mm occlusal reduction with diamond burs; a 1-2 mm subgingival preparation will be made from the gingival margin. The proximal surfaces will be reduced approximately 1 mm thick, starting from the occlusal and buccally, lingually, and gingivally from the mesial and distal contact points of the tooth.
- In order to achieve full adaptation to the tooth, after any necessary corrections, the crown edge will be curved with the help of forceps, and the edge will be trimmed with scissors or a bur until cervical adaptation is achieved. The shortened crown edges will be polished with the help of discs and rubbers.
- The teeth to be coated with zirconium will be prepared subgingivally from 2 mm occlusal and 1-2 mm from the gingival margin in accordance with the manufacturer's instructions.
- Since zirconia crowns are not flexible, the mesial and distal walls will be prepared parallel to the adjacent teeth, taking into account the distance to ensure passive adaptation.
- A conical diamond bur will be used in proximal reduction to ensure passive seating of the selected crown. The appropriate size crown will be found by trial.
- After the appropriate crown is selected for zirconia crowns, a cotton pellet moistened with sterile serum is applied to the area for 5 minutes to control bleeding, and the bleeding will be stopped. If necessary, bleeding control agents or retraction cords will be used to prevent active bleeding during cementation.
- The crowns in both groups are cemented with FujiCEM Evolve (GC, Tokyo, Japan). This cement in the RMCIS group is in paste form. It is applied directly into the crown in an injectable form with its own special tip and polymerized with a light device for 10 seconds. The cement residue accumulated at the gingival margin is cleaned with a probe, and a setting time of 4-5 minutes is waited in accordance with the manufacturer's instructions. Occlusion is checked. After the cementation is completed with the appropriate application technique, the cement residue accumulated at the gingival margin is cleaned with a probe tip. If a scratch occurs on the crowns during this process, this mark is cleaned with a bur, and the surface is polished with polishing discs.
In general, in the evaluation of success:
- Teeth that have been extracted due to abscess development in control appointments.
- Dissolution of cement and decementation of the crown.
- Internal and external root resorption seen in radiographic evaluation.
- Teeth with lesions in the furcation region.
- Teeth with widening in the periodontal ligament space will be evaluated as unsuccessful.
Plaque Index and Gingival Index in pediatric prefabricated stainless steel and zirconia crowns applied to asymptomatic primary mandibular second molars after pulpotomy will be evaluated at baseline and at the 1-month, 3-month, 6-month, and 12-month follow-ups. Tooth Wear Index, Modified United States Public Health Service (USPHS) Criteria, and parental satisfaction will also be assessed at the 1-month, 3-month, 6-month and 12-month follow-ups. Intraoral photographs will be taken immediately after treatment and at each follow-up appointment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prefabricated stainless steel crowns (Group A) | Experimental | Other: prefabricated stainless steel crownsGroups that received prefabricated stainless steel crowns |
| Prefabricated zirconia crowns (Group B) | Experimental | Other: prefabricated zirconia crownsGroups that received prefabricated zirconia crowns |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age range of children from 4 to 5 years.
- Systemically healthy.
- Children who are positive and extremely positive according to the Frankl behavior scale.
- Asymptomatic primary mandibular second molars with multi-surface deep caries requiring pulpotomy treatment.
- No history of spontaneous pain.
Key exclusion criteria (7 listed)
- Having a systemic disease.
- Periapical infection, abscess, or mobility in primary second molars.
- Those with active periodontal disease.
- Malocclusion or missing opposing tooth.
- Primary second molars with pathological internal or external resorption.
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 |
|---|---|---|
| prefabricated stainless steel crownsFull coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy | Other | prefabricated stainless steel crowns (Group A) |
| prefabricated zirconia crownsFull coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy | Other | Prefabricated zirconia crowns (Group B) |
Primary outcome
Change in periodontal health (Gingiva)
Time frame: baseline, 1 months, 3 months, 6 months, 12 months
Gingival evaluation of the patients will be made according to the Loe and Silness Gingival Index. According to this index system: 0 : Normal (absence of inflammation) 1. : Mild gingivitis (slight change in color, slight edema; no bleeding on probing) 2. : Moderate gingivitis (redness, edema, and glazing; bleeding on probing) 3. : Severe gingivitis (marked redness and edema; ulceration; tendency to spontaneous bleeding)
Change in periodontal health (Plaque)
Time frame: baseline, 1 months, 3 months, 6 months, 12 months
Plaque evaluation of the patients will be performed according to Silness and Loe Plaque Index. After the teeth isolated with cotton before the evaluation are air dried, the amount of plaque in the area near the gingival margin of each tooth will be examined by inspection and examination probe. According to this index system:: 0: No plaque. 1. A thin layer of plaque is visible along the gingival margin. This thin layer can be detected with the examination probe. 2. A moderate layer of plaque is visible along the gingival margin. This plaque can be visually detected. 3. Heavy plaque accumulation is detected at the gingival margin and in the interdental area.
Wear of opposing natural teeth
Time frame: 1 months, 3 months, 6 months, 12 months
The Smith and Knight Tooth Wear Index classification, which is used to grade tooth wear, will be applied. The Smith and Knight Tooth Wear Index criteria are as follows: 0 Points (Buccal/lingual/occlusal/incisal): No loss of enamel surface characteristics (Cervical): No contour loss. Score 1 (Buccal/lingual/occlusal/incisal): Loss of enamel surface features (cervical): Minimal contour loss. Score 2 (Buccal/lingual/occlusal): Dentin opening with enamel loss of less than 1/3 of the surface (incisal): Dentin exposure with enamel loss (cervical): Less than 1 mm defect. Score 3 (Buccal/lingual/occlusal): More than 1/3 of the dentin surface exposed with enamel loss (incisal): Enamel loss and significant dentin loss (cervical): 1-2 mm defect. Score 4 (Buccal/lingual/occlusal): Complete loss of enamel or exposure of pulp/secondary dentin (incisal): Opening of pulp or secondary dentin (cervical): Defect larger than 2 mm or pulp/secondary dentin dehiscence.
Change in clinical performance
Time frame: 1 months, 3 months, 6 months, 12 months
Modified United States Public Health Service (USPHS) criteria will be used to evaluate color match, retention, marginal integrity, marginal discoloration, anatomic form, secondary caries, surface roughness, surface gloss and postoperative sensitivity. Restorations are evaluated and scored alphabetically. When evaluated in terms of any criterion; A: ideal restorations, B: restorations that are not ideal but within acceptable limits, C: restorations that are clinically unacceptable and need to be replaced, D: restorations that are already mobile or damage tissues receive a score of D. During clinical examination and recording, phonetically similar nomenclature is used to avoid misunderstanding of the score in terms of the letter pronounced by the physician: 'A'lfa, 'B'ravo, 'C'harlie, 'D'elta.
1 secondary outcome
Measuring of parental satisfaction
Time frame: 1 months, 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No. Individual Patient Data (IPD) will not be shared 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.
Kadriye Görkem Ulu Güzel, Doç. Prof. study director
Adnan Menderes Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prefabricated stainless steel crowns and prefabricated zirconia crowns in people with Dental Caries and Pulpotomy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kadriye Görkem Ulu Güzel, Doç. Prof (505-764-6372, gorkem.ulu@adu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in periodontal health (Gingiva) (time frame: baseline, 1 months, 3 months, 6 months, 12 months). The study lists 4 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 22 Dec 2025.