Dental CariesNCT06558747
Comparison of the Clinical Success of Pediatric Zirconia Crowns Applied with Different Luting Cements
A study testing Tooth Preperation and Cementation in people with Dental Caries and Dental Plaque, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate and compare the clinical outcomes of prefabricated zirconia crowns (PZCs) for primary molars cemented with different luting cements. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Plaque, Dental Caries in Children
- What is being tested?
- Tooth Preperation and Cementation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2017to 8 Mar 2019
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients:
- no history of allergies
- a Frankl scale score of 3 or 4
- has at least one carious primary molar
- Teeth:
- No percussion or palpation sensitivity
Show all 17Show fewer
- No pathological root resorption
- No abscess and/or fistula
- No radiolucency at the furcation area
- No prior pulpal treatment
- Presence of permanent successor
- No mobility or periodontal disease
- Normal position of permanent successor
- An interproximal decay and/or extensive decay with at least 2 surfaces
- If present, physiological root resorption no more than one-third of the root
- Opposing teeth in occlusal contact
- Normal lamina dura and periodontal space
Who cannot join
- congenital and/or developmental defects
- history of bruxism
- skeletal and/or dental malocclusion
- history of trauma
- infraocclusion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Pediatric Dentistry, Akdeniz University
Antalya
About this study
This randomized controlled trial aims to evaluate and compare the clinical outcomes of prefabricated zirconia crowns (PZCs) for primary molars cemented with different luting cements. The main questions to answer are:
Will there be any difference in the clinical success regarding retention among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding periodontal health among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding pulpal survival among the PZCs cemented with different luting cements? Fifty-three children (60 teeth), between 5 and 11 years old enrolled for the study. Researchers will compare the retention status, plaque index (PI), gingival index (GI), and probing depth (PD) scores, and endodontic/periodontal pathology of PZCs.
Read more
Participants will:
- visit the clinic 1st,3rd,6th,12th months after the restoration.
- Conditions
- Dental Caries, Dental Plaque, Dental Caries in Children
- Being tested
- Tooth Preperation, Cementation
- Medical subject headings
- Dental Caries, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth PreperationProcedure or surgery
After the caries were removed, the teeth were prepared by shaving according to the manufacturer's recommendations for NuSmile ZR.
CementationProcedure or surgery
Pediatric zirconia crowns were placed on the prepared teeth with finger pressure, following the manufacturer's instructions for the luting cement to be used. For each cement, the recommended setting time was observed, and excess cement residues were removed accordingly.
| Study group | Role | What they receive |
|---|---|---|
| Device: Bioactive Cement | Experimental | BioCem™ (NuSmile, Texas, USA) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth. Crowns were stabilized for 20 seconds before applying halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) to the buccal and lingual/palatal surfaces for three seconds each. Receives: Procedure: Tooth Preperation; Procedure: Cementation |
| Device: Resin Cement | Experimental | The inner surface of the crowns was treated with 'G-Multi Primer' using a brush and subsequently air-dried. The surfaces of the prepared teeth were treated with 37% orthophosphoric acid. The tooth surfaces were rinsed with an air-water spray to remove the acid from the surfaces. After the etching process, the 'G-Premio Bond' was applied to the teeth surfaces with a brush, rubbed for 10 seconds, and then air-dried for five seconds. Then the teeth were exposed to halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) for 10 seconds. G-CEM Linkforce (GC, USA) resin cement was gently applied to crowns, and then crowns were pressed onto the prepared teeth with finger pressure. Receives: Procedure: Tooth Preperation; Procedure: Cementation |
| Device: Glass-ionomer cement | Experimental | The capsule was attached to the mixer and mixed for 10 seconds. The cement was evenly distributed to the crowns paying attention that there were no air voids. Then crowns were placed by pressing them onto the prepared teeth with finger pressure. Receives: Procedure: Tooth Preperation; Procedure: Cementation |
| Device: Resin-modified glass-ionomer cement | Experimental | The cement was placed into the crown with the self-mixing syringe, ensuring no air voids were created. The crowns were then seated onto the teeth with finger pressure. Receives: Procedure: Tooth Preperation; Procedure: Cementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Status
The clinical success of the crowns regarding the retention status was evaluated as either present or absent based on whether the crown remained on the restored tooth at each follow-up appointment. Crowns that were still in place during the follow-up visit were considered successful in terms of retention, while those that had decemented were considered unsuccessful.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Secondary outcomes (4)
Pulpal Survival
Maintaining pulpal vitality is also a criterion for the success of a restoration and is assessed not by a graded score but by the presence or absence of symptoms and findings. In this study, pulpal vitality was clinically evaluated based on the presence or absence of percussion sensitivity, palpation sensitivity, gingival redness, fistula or abscess. If percussion sensitivity, palpation sensitivity, or the formation of a fistula or abscess were present, the restoration was classified as unsuccessful regarding pulpal vitality. In cases of gingival redness or unclear clinical symptoms, a periapical radiograph was taken. If presence or absence of radiolucency in the periapical or furcal area was detected in the radiograph, the restoration was classified as unsuccessful regarding pulpal vitality.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Plaque Index
The clinical success of a full-coverage restoration is also related to periodontal health. The impact of the luting cement on periodontal health was investigated by recording the plaque index (PI), at all follow-up visits. The PI was recorded based on the criteria established by Silness and Löe, with 0 being the best and 3 being the worst. The recorded scores were compared among the groups.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Gingival Index
The clinical success of a full-coverage restoration is also related to periodontal health. The impact of the luting cement on periodontal health was investigated by recording the gingival index (GI) at all follow-up visits. The GI were recorded based on the criteria established by Silness and Löe, with 0 being the best and 3 being the worst. The recorded scores were compared among the groups.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Probing Depth
The clinical success of a full-coverage restoration is also related to periodontal health. The impact of the luting cement on periodontal health was investigated by measuring the probing depth (PD) of each crown at all follow-up visits. PD was measured using a universal periodontal probe by probing the gingival sulcus. The gingival sulcus is the space between the free gingiva and the tooth. It has a V-shape and allows the periodontal probe to enter. Clinically, a healthy gingival sulcus depth ranges from 0.5 to 2 mm on the buccal and lingual surfaces, while a pocket depth of up to 3 mm is considered normal in the proximal areas. A deeper pocket depth is considered an indication of periodontal disease. The recorded scores were compared among the groups.
Measured: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start20 Nov 2017
- Primary completion8 Mar 2018
- Study completion8 Mar 2019
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 Akdeniz 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hüseyin Karayılmaz, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558747
- Sponsor's protocol ID
- TDK-2016-1761
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Success of Pediatric Zirconia Crowns Applied with Different Luting Cements
- ClinicalTrials.gov ID
- NCT06558747
- Acronym / sponsor ID
- TDK-2016-1761
- Conditions
- Dental Caries, Dental Plaque, Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 19 Aug 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.
This randomized controlled trial aims to evaluate and compare the clinical outcomes of prefabricated zirconia crowns (PZCs) for primary molars cemented with different luting cements. The main questions to answer are:
Will there be any difference in the clinical success regarding retention among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding periodontal health among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding pulpal survival among the PZCs cemented with different luting cements? Fifty-three children (60 teeth), between 5 and 11 years old enrolled for the study. Researchers will compare the retention status, plaque index (PI), gingival index (GI), and probing depth (PD) scores, and endodontic/periodontal pathology of PZCs.
Participants will:
- visit the clinic 1st,3rd,6th,12th months after the restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Device: Bioactive Cement | Experimental | Procedure: Tooth Preperation, Procedure: CementationBioCem™ (NuSmile, Texas, USA) was evenly distributed to the inner surface of the crown with the syringe and immediately placed onto the teeth. Crowns were stabilized for 20 seconds before applying halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) to the buccal and lingual/palatal surfaces for three seconds each. |
| Device: Resin Cement | Experimental | Procedure: Tooth Preperation, Procedure: CementationThe inner surface of the crowns was treated with 'G-Multi Primer' using a brush and subsequently air-dried. The surfaces of the prepared teeth were treated with 37% orthophosphoric acid. The tooth surfaces were rinsed with an air-water spray to remove the acid from the surfaces. After the etching process, the 'G-Premio Bond' was applied to the teeth surfaces with a brush, rubbed for 10 seconds, and then air-dried for five seconds. Then the teeth were exposed to halogen/LED light (800-1200mW/cm2) (Valo Cordless, Ultradent) for 10 seconds. G-CEM Linkforce (GC, USA) resin cement was gently applied to crowns, and then crowns were pressed onto the prepared teeth with finger pressure. |
| Device: Glass-ionomer cement | Experimental | Procedure: Tooth Preperation, Procedure: CementationThe capsule was attached to the mixer and mixed for 10 seconds. The cement was evenly distributed to the crowns paying attention that there were no air voids. Then crowns were placed by pressing them onto the prepared teeth with finger pressure. |
| Device: Resin-modified glass-ionomer cement | Experimental | Procedure: Tooth Preperation, Procedure: CementationThe cement was placed into the crown with the self-mixing syringe, ensuring no air voids were created. The crowns were then seated onto the teeth with finger pressure. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- no history of allergies
- a Frankl scale score of 3 or 4
- has at least one carious primary molar
- No percussion or palpation sensitivity
- No pathological root resorption
Key exclusion criteria (5 listed)
- congenital and/or developmental defects
- history of bruxism
- skeletal and/or dental malocclusion
- history of trauma
- 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 |
|---|---|---|
| Tooth PreperationAfter the caries were removed, the teeth were prepared by shaving according to the manufacturer's recommendations for NuSmile ZR. | Procedure or surgery | Device: Bioactive Cement, Device: Glass-ionomer cement, Device: Resin Cement, Device: Resin-modified glass-ionomer cement |
| CementationPediatric zirconia crowns were placed on the prepared teeth with finger pressure, following the manufacturer's instructions for the luting cement to be used. For each cement, the recommended setting time was observed, and excess cement residues were removed accordingly. | Procedure or surgery | Device: Bioactive Cement, Device: Glass-ionomer cement, Device: Resin Cement, Device: Resin-modified glass-ionomer cement |
Primary outcome
Retention Status
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
The clinical success of the crowns regarding the retention status was evaluated as either present or absent based on whether the crown remained on the restored tooth at each follow-up appointment. Crowns that were still in place during the follow-up visit were considered successful in terms of retention, while those that had decemented were considered unsuccessful.
4 secondary outcomes
Pulpal Survival
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Plaque Index
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Gingival Index
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Probing Depth
Time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth Preperation and Cementation in people with Dental Caries and Dental Plaque, run by Akdeniz 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 17 inclusion and 5 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 Oct 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 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?
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?
Retention Status (time frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.