Caries,DentalNCT06690229

Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns

A study testing glass ionomer cement, self-adhesive resin cement and resin modified glass ionomer cement in people with Caries,Dental, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Today, with increasing aesthetic demands; the need for materials that are both durable and compatible with the appearance of natural teeth is increasing in paediatric dentistry. Prefabricated zirconium crowns have attracted significant interest in recent years because they meet aesthetic expectations and have offer… Read more about this study

Who is it for?: Ages 3 to 4 years
Conditions the study is for: Caries,Dental
What is being tested?: glass ionomer cement, self-adhesive resin cement and resin modified glass ionomer cement
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 5 Jun 2024to 31 Dec 2026
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 3 to 4 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients with consenting parents,
Patients with carious lesions on 2 or more faces of maxillary incisors or interface caries
Those whose related teeth have not undergone pulp treatment,
Patients without periodontal-related attachment loss, without tooth loss as a result of periodontal pathology,
Those requiring treatment with general anaesthesia
Score 1 and score 2 on the Frankl behaviour scale

Show all 18Show fewer

Those without a history of allergy (such as local anaesthesia, medication, resin-based restorative materials),
Not requiring endocarditis prophylaxis,
No hypoplasia and hypomineralisation of teeth,
Patients whose permanent teeth are more than 1 year away from eruption
Patients with vital teeth and no complaints of percussion, palpation tenderness, nocturnal waking pain and no abscess and/or fistula
Teeth with a healthy lamina dura and periapical appearance
Teeth without mobility and pathological gingival pockets
Teeth with physiological root resorption not exceeding the apical 1/3 level,
No more than 2 mm alveolar bone loss in the interproximal region on the radiograph of the tooth,
No pathological internal or external root resorption,
It has a permanent tooth underneath and its position is normal,
Patients with a flush terminal closure relationship will be included in the study.

Who cannot join

Teeth with periapical infection, abscess or mobility,
In cases where the depth of the gingival pocket exceeds 3 mm,
In the presence of pathological mobility,
In the presence of congenital developmental defects (amelogenesis imperfecta, dentinogenesis imperfecta),
In teeth in infraocclusion,
Patients with abnormal bite due to dental or skeletal orthodontic anomalies,

Show all 17Show fewer

In the presence of pathological internal or external resorption,
In cases where radiographic bone loss of more than 2 mm in the interdental region is observed
Those with active periodontal disease,
Traumatised teeth,
In cases where the overjet is more than 2 mm,
Patients with deep bite
Cases where the opposite tooth is missing,
Patients with systemic diseases (diseases of the cardiovascular system, endocrine system, urinary system, central nervous system, mental disorders, etc.),
Dangerous medical conditions or harmful oral habits,
Children with bruxism or unilateral chewing habits will not be included in the study.
Those who wish to withdraw from the study at any stage will be excluded from the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Aydin Adnan Menderes University
Aydin, Efeler, 09100

Other trials in Turkey (Türkiye)

About this study

The aim of this study is to clinically evaluate prefabricated zirconia crowns cemented to the primary maxillary incisors with three different adhesive cements in terms of periodantal health, plaque accumulation, opposing tooth wear, parental satisfaction, color harmony, retention, marginal integrity and contact compatibility, at the 1-week, 3-month, 6-month, 12-month follow-ups.

Read the detailed description

The sample size was calculated as 30 with the G*Power analysis program. Considering the case losses, the sample size will be increased by 20% and a total of 36 teeth will be included. In the study, 3 different cements will be applied to each cement group, 12 teeth.

In this study, 36 teeth will be included from patients aged 3-4 years who have two or more surface carious lesions on their maxillary incisors. After necessary caries removal and pulpectomy treatment, prefabricated zirconia crowns will be prepared and cemented under general anesthesia, using one of three randomly selected cements.

12 teeth will be cemented with FujiCEM Evolve (GC, Tokyo, Japan) 12 teeth with RelyX U200 (3M ESPE, St. Paul, USA) 12 teeth with Ketac Cem (3M ESPE, USA) Patients will be called for follow-up examinations one week after the completion of all dental treatments and at 3, 6, and 12 months. During these follow-ups, Gingival Index, Plaque Index, Tooth Wear Index, and Ryge (USPHS) Criteria will be evaluated on the teeth, and a parental satisfaction scale will be completed.

Conditions: Caries,Dental
Being tested: glass ionomer cement, self-adhesive resin cement, resin modified glass ionomer cement
Keywords: Early childhood caries, Zirconia crown, Cementation
Medical subject headings: Dental Caries

What participants receive

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

glass ionomer cementDrug
Also called Ketac Cem (3M ESPE, USA)
A cement used for crown cementation
self-adhesive resin cementDrug
Also called RelyX U200 (3M ESPE, St. Paul, USA)
A cement used for crown cementation
resin modified glass ionomer cementDrug
Also called FujiCEM Evolve (GC, Tokyo, Japan)
A cement used for crown cementation

Study groups in NCT06690229
Study group	Role	What they receive
glass ionomer cement	Experimental	Prefabricated zirconia crowns cemented with glass ionomer cement (Ketac Cem (3M ESPE, USA)) on primary maxillary incisors will be clinically evaluated at 1-week, 3-month, 6-month, and 12-month follow-ups in terms of periodontal health, plaque accumulation, wear of opposing teeth, parental satisfaction, color match, retention, marginal integrity, and contact harmony Receives: Drug: glass ionomer cement
dual-cure self-adhesive resin cement	Experimental	Prefabricated zirconia crowns will be cemented with dual-cure self-adhesive resin cement (RelyX U200 (3M ESPE, St. Paul, USA)) on primary maxillary incisors and will be evaluated during follow-up sessions. Receives: Drug: self-adhesive resin cement
resin modified glass ionomer cement	Experimental	Prefabricated zirconia crowns will be cemented with resin modified glass ionomer cement (FujiCEM Evolve (GC, Tokyo, Japan)) on primary maxillary incisors and will be evaluated during follow-up sessions. Receives: Drug: resin modified glass ionomer cement

What is being measured

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

Change in clinical performance.
Modified United States Public Health Service (USPHS) criteria will be used to evaluate retention, marginal integrity, secondary caries, color match, and crown fracture.
Restorations are evaluated using an alphabetical grading scale. When assessing based on specific criteria:
Alpha (A), represents ideal restorations, Bravo (B), denotes restorations that are not ideal but remain within acceptable limits, Charlie (C), refers to restorations that fall outside clinically acceptable boundaries and require replacement, Delta (D) is assigned to restorations that are either currently mobile or causing damage to surrounding tissues.
Measured: 1 week, 3 months, 6 months, 12 months
Change in periodontal health (Plaque)
Periodontal health will be assessed using the Plaque index (PI).
Each of the four surfaces of a tooth will be assigned an index score from 0 to 3 based on the amount of plaque observed:
0: No plaque is present.
1. A thin layer of plaque is observed along the gingival margin; this thin layer can be detected with a probe.
2. A moderate layer of plaque is observed along the gingival margin, visible to the eye.
3. A substantial amount of plaque is observed at the gingival margin, with interdental areas visibly filled with plaque.
Measured: 1 week, 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 incisal surfaces of all teeth will be examined.
Score 0:
(Buccal/Lingual/Occlusal/Incisal): No loss of enamel surface characteristics. (Cervical): No loss of contour.
Score 1:
(B/L/O/I): Loss of enamel surface characteristics. (C): Minimal loss of contour.
Score 2:
(B/L/O): Loss of enamel exposing dentine for less than one third of surface. (I): Loss of enamel just exposing dentine. (C): Defect less than 1 mm deep.
Score 3:
(B/L/O): Loss of enamel exposing dentine for more than one third of surface. (I): Loss of enamel and substantial loss of dentine (C): Defect less than 1-2 mm deep.
Score 4:
(B/L/O): Complete enamel loss-pulp exposure- secondary dentin exposure. (I): Pulp exposure or exposure of secondary dentine. (C): Defect more than 2 mm deep-pulp exposure- secondary dentine exposure.
Measured: 1 week, 3 months, 6 months, 12 months
Measuring of parental satisfaction
Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction.
1. Very dissatisfied
2. Dissatisfied
3. Undecided
4. Satisfied
5. Very satisfied
Measured: 1 week, 3 months, 6 months, 12 months
Change in periodontal health (Gingiva)
Periodontal health will be assessed using the Gingival index (GI).
The degree of inflammation and bleeding at each of the four surfaces of a tooth will be assessed using the following index system:
0: No visible signs of inflammation.
1. Mild inflammation with slight color change and edema; no bleeding.
2. Visible, moderate inflammation with a tendency to bleed when a periodontal probe is gently passed along the soft tissue wall of the gingival sulcus.
3. Severe inflammation with marked redness, edema, and spontaneous bleeding.
Measured: 1 week, 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.

5 Jun 202431 Dec 2026

First posted15 Nov 2024
Study start5 Jun 2024
Primary completion31 Aug 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Caries,DentalStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06690229
Sponsor's protocol ID: 2023/037
Status last verified: Sep 2025
First submitted: 11 Nov 2024
Last updated: 21 Nov 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

Publications

Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.
PubMed 6935165
Smith BG, Knight JK. An index for measuring the wear of teeth. Br Dent J. 1984 Jun 23;156(12):435-8. doi: 10.1038/sj.bdj.4805394. No abstract available.
PubMed 6590081
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PubMed 14158464
LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956
Cohn C. Zirconia-Prefabricated Crowns for Pediatric Patients With Primary Dentition: Technique and Cementation for Esthetic Outcomes. Compend Contin Educ Dent. 2016 Sep;37(8):554-8.
PubMed 27608199
Srinivasan SR, Mathew MG, Jayaraman J. Comparison of Three Luting Cements for Prefabricated Zirconia Crowns in Primary Molar Teeth: a 36-month Randomized Clinical Trial. Pediatr Dent. 2023 Mar 15;45(2):117-124.
PubMed 37106541
Alrashdi M, Ardoin J, Liu JA. Zirconia crowns for children: A systematic review. Int J Paediatr Dent. 2022 Jan;32(1):66-81. doi: 10.1111/ipd.12793. Epub 2021 Apr 25.
PubMed 33772904
Alzanbaqi SD, Alogaiel RM, Alasmari MA, Al Essa AM, Khogeer LN, Alanazi BS, Hawsah ES, Shaikh AM, Ibrahim MS. Zirconia Crowns for Primary Teeth: A Systematic Review and Meta-Analyses. Int J Environ Res Public Health. 2022 Feb 28;19(5):2838. doi: 10.3390/ijerph19052838.
PubMed 35270531

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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns
ClinicalTrials.gov ID: NCT06690229
Acronym / sponsor ID: 2023/037
Conditions: Caries,Dental
Keywords: Early childhood caries, Zirconia crown, Cementation
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 36 participants (estimated)
Lead sponsor: Aydin Adnan Menderes UniversityUniversity, hospital or other
Study start: 5 Jun 2024 (actual)
Primary completion: 31 Aug 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 15 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
glass ionomer cement	Experimental	Drug: glass ionomer cementPrefabricated zirconia crowns cemented with glass ionomer cement (Ketac Cem (3M ESPE, USA)) on primary maxillary incisors will be clinically evaluated at 1-week, 3-month, 6-month, and 12-month follow-ups in terms of periodontal health, plaque accumulation, wear of opposing teeth, parental satisfaction, color match, retention, marginal integrity, and contact harmony
dual-cure self-adhesive resin cement	Experimental	Drug: self-adhesive resin cementPrefabricated zirconia crowns will be cemented with dual-cure self-adhesive resin cement (RelyX U200 (3M ESPE, St. Paul, USA)) on primary maxillary incisors and will be evaluated during follow-up sessions.
resin modified glass ionomer cement	Experimental	Drug: resin modified glass ionomer cementPrefabricated zirconia crowns will be cemented with resin modified glass ionomer cement (FujiCEM Evolve (GC, Tokyo, Japan)) on primary maxillary incisors and will be evaluated during follow-up sessions.

Who may qualify

Ages: 3 to 4 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (18 listed)

Patients with consenting parents,
Patients with carious lesions on 2 or more faces of maxillary incisors or interface caries
Those whose related teeth have not undergone pulp treatment,
Patients without periodontal-related attachment loss, without tooth loss as a result of periodontal pathology,
Those requiring treatment with general anaesthesia

Key exclusion criteria (17 listed)

Teeth with periapical infection, abscess or mobility,
In cases where the depth of the gingival pocket exceeds 3 mm,
In the presence of pathological mobility,
In the presence of congenital developmental defects (amelogenesis imperfecta, dentinogenesis imperfecta),
In teeth in infraocclusion,

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
glass ionomer cementAlso: Ketac Cem (3M ESPE, USA)A cement used for crown cementation	Drug	glass ionomer cement
self-adhesive resin cementAlso: RelyX U200 (3M ESPE, St. Paul, USA)A cement used for crown cementation	Drug	dual-cure self-adhesive resin cement
resin modified glass ionomer cementAlso: FujiCEM Evolve (GC, Tokyo, Japan)A cement used for crown cementation	Drug	resin modified glass ionomer cement

Primary outcome

Change in clinical performance.
Time frame: 1 week, 3 months, 6 months, 12 months
Modified United States Public Health Service (USPHS) criteria will be used to evaluate retention, marginal integrity, secondary caries, color match, and crown fracture. Restorations are evaluated using an alphabetical grading scale. When assessing based on specific criteria: Alpha (A), represents ideal restorations, Bravo (B), denotes restorations that are not ideal but remain within acceptable limits, Charlie (C), refers to restorations that fall outside clinically acceptable boundaries and require replacement, Delta (D) is assigned to restorations that are either currently mobile or causing damage to surrounding tissues.
Change in periodontal health (Plaque)
Time frame: 1 week, 3 months, 6 months, 12 months
Periodontal health will be assessed using the Plaque index (PI). Each of the four surfaces of a tooth will be assigned an index score from 0 to 3 based on the amount of plaque observed: 0: No plaque is present. 1. A thin layer of plaque is observed along the gingival margin; this thin layer can be detected with a probe. 2. A moderate layer of plaque is observed along the gingival margin, visible to the eye. 3. A substantial amount of plaque is observed at the gingival margin, with interdental areas visibly filled with plaque.
Wear of opposing natural teeth
Time frame: 1 week, 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 incisal surfaces of all teeth will be examined. Score 0: (Buccal/Lingual/Occlusal/Incisal): No loss of enamel surface characteristics. (Cervical): No loss of contour. Score 1: (B/L/O/I): Loss of enamel surface characteristics. (C): Minimal loss of contour. Score 2: (B/L/O): Loss of enamel exposing dentine for less than one third of surface. (I): Loss of enamel just exposing dentine. (C): Defect less than 1 mm deep. Score 3: (B/L/O): Loss of enamel exposing dentine for more than one third of surface. (I): Loss of enamel and substantial loss of dentine (C): Defect less than 1-2 mm deep. Score 4: (B/L/O): Complete enamel loss-pulp exposure- secondary dentin exposure. (I): Pulp exposure or exposure of secondary dentine. (C): Defect more than 2 mm deep-pulp exposure- secondary dentine exposure.
Measuring of parental satisfaction
Time frame: 1 week, 3 months, 6 months, 12 months
Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction. 1. Very dissatisfied 2. Dissatisfied 3. Undecided 4. Satisfied 5. Very satisfied
Change in periodontal health (Gingiva)
Time frame: 1 week, 3 months, 6 months, 12 months
Periodontal health will be assessed using the Gingival index (GI). The degree of inflammation and bleeding at each of the four surfaces of a tooth will be assessed using the following index system: 0: No visible signs of inflammation. 1. Mild inflammation with slight color change and edema; no bleeding. 2. Visible, moderate inflammation with a tendency to bleed when a periodontal probe is gently passed along the soft tissue wall of the gingival sulcus. 3. Severe inflammation with marked redness, edema, and spontaneous bleeding.

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 21 Nov 2025.
Background: PubMed 6935165Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.
Background: PubMed 6590081Smith BG, Knight JK. An index for measuring the wear of teeth. Br Dent J. 1984 Jun 23;156(12):435-8. doi: 10.1038/sj.bdj.4805394. No abstract available.
Background: PubMed 14158464SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
Background: PubMed 27608199Cohn C. Zirconia-Prefabricated Crowns for Pediatric Patients With Primary Dentition: Technique and Cementation for Esthetic Outcomes. Compend Contin Educ Dent. 2016 Sep;37(8):554-8.
Background: PubMed 37106541Srinivasan SR, Mathew MG, Jayaraman J. Comparison of Three Luting Cements for Prefabricated Zirconia Crowns in Primary Molar Teeth: a 36-month Randomized Clinical Trial. Pediatr Dent. 2023 Mar 15;45(2):117-124.
Background: PubMed 33772904Alrashdi M, Ardoin J, Liu JA. Zirconia crowns for children: A systematic review. Int J Paediatr Dent. 2022 Jan;32(1):66-81. doi: 10.1111/ipd.12793. Epub 2021 Apr 25.
Background: PubMed 35270531Alzanbaqi SD, Alogaiel RM, Alasmari MA, Al Essa AM, Khogeer LN, Alanazi BS, Hawsah ES, Shaikh AM, Ibrahim MS. Zirconia Crowns for Primary Teeth: A Systematic Review and Meta-Analyses. Int J Environ Res Public Health. 2022 Feb 28;19(5):2838. doi: 10.3390/ijerph19052838.
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. This study is not recruiting at the moment.

Kadriye Görkem Ulu Güzel, Assoc. Prof. study director

gorkemulu@yahoo.com

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 18 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 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?

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?

Change in clinical performance. (time frame: 1 week, 3 months, 6 months, 12 months). 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 NCT06690229, which also lists 8 linked publications.

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 21 Nov 2025.