Dental CariesNCT07611734
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
A study testing Cementation with Fuji IX GP Extra Glass Ionomer Cement, Cementation with BioCem™ Universal BioActive Cement and Cementation with RelyX™ Universal Resin Cement in people with Dental Caries and Tooth Injuries, run by Murad Alrashidi at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to compare the long-term clinical performance of three different luting cements used to bond prefabricated zirconia crowns (PZCs) on primary front teeth in young children. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Tooth Injuries, Primary Tooth Restoration
- What is being tested?
- Cementation with Fuji IX GP Extra Glass Ionomer Cement, Cementation with BioCem™ Universal BioActive Cement and Cementation with RelyX™ Universal Resin Cement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 May 2026to Jul 2029
- 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 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 2 to 7 years
- One or more primary maxillary or mandibular incisors requiring full-coverage restoration due to caries or trauma
- Adequate remaining tooth structure following preparation, defined as greater than 50% of the clinical crown
- Parent or legal guardian able and willing to provide written informed consent and to commit to the 36-month follow-up schedule
Who cannot join
- Active periodontal disease at the index tooth, defined as a Löe Gingival Index score of 2 or higher
- Parafunctional habits such as bruxism, severe thumb-sucking, or tongue-thrust documented at screening
- Known allergy or hypersensitivity to zirconia, resin, glass ionomer, or any component of the assigned cement
- Inconsistent oral hygiene, defined as less than twice-daily toothbrushing per parental report
- Systemic disease affecting bone metabolism, tooth development, or wound healing
- Current participation in another interventional dental clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Self-Adhesive Resin, Conventional Glass Ionomer, and Bioactive Resin-Modified Glass Ionomer Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth: A Randomized Controlled Trial
The goal of this clinical trial is to compare the long-term clinical performance of three different luting cements used to bond prefabricated zirconia crowns (PZCs) on primary front teeth in young children. The trial will determine whether any single cement offers superior retention, gum health, or marginal sealing compared to the others over a 3-year period.
Main Questions:
Read more
The study aims to answer the following:
Are conventional glass ionomer cement (GIC), bioactive resin-modified glass ionomer cement (BioCem™), and self-adhesive resin cement (SARC) equivalent in retaining prefabricated zirconia crowns on primary incisors over 36 months? Do these cements differ in their effect on gingival health, plaque accumulation, or marginal discoloration around the cemented crown?
Comparison:
Researchers will compare three parallel groups of children whose primary incisors are restored with identical prefabricated zirconia crowns but cemented with one of the three different luting cements.
Participants will: Receive a clinical and radiographic dental examination at screening. Undergo placement of one or more prefabricated zirconia crowns on primary anterior teeth using their randomly assigned cement. Return to the clinic for blinded follow-up evaluations at 12, 24, and 36 months for assessment of crown retention, gingival health, plaque, and marginal staining.
Read the detailed description
This prospective, parallel-group, three-arm, randomized controlled trial evaluates the long-term clinical performance of three commercially available luting cements when used to bond prefabricated zirconia crowns (PZCs) on primary anterior teeth in pediatric patients. Although PZCs are increasingly preferred over stainless steel crowns for anterior restorations due to their superior esthetics and biocompatibility, their retention relies entirely on the luting cement because of their passive fit and conservative preparation design. Comparative clinical evidence on cement performance in this specific anatomical and functional context remains limited.
Trial Design:
The trial is conducted at the Pediatric Dental Clinic of Qassim University, Riyadh, Saudi Arabia. Eligible children aged 2 to 7 years requiring full-coverage restoration of one or more primary incisors are randomized in a 1:1:1 ratio to one of three cement groups using a computer-generated randomization sequence. Allocation labels are reshuffled after each assignment to preserve equal group sizes. An independent outcome assessor is blinded to group allocation throughout the trial, and standardized cheek retractors are used to mask cement margins during evaluations. Operators cannot be blinded due to material-specific application protocols.
Intervention Protocols:
Tooth preparation follows standardized anterior-specific minimal reduction principles (1.0-1.5 mm incisal, 0.5-0.8 mm uniform labial, feather-edge proximal margins) under rubber dam isolation. NuSmile® prefabricated zirconia crowns are used for all participants. Cement application follows manufacturer instructions for each group:
Group 1 (GIC): Fuji IX GP Extra (GC America) - tooth conditioned with 20% polyacrylic acid for 20 seconds, rinsed, gently air-dried; cement hand-mixed, loaded into crown, seated under finger pressure for 3 minutes.
Group 2 (BioCem™): BioCem™ Universal BioActive Cement (NuSmile®) - tooth cleaned with pumice and water, rinsed, dried; cement auto-mixed into crown, seated, briefly light-cured (2-3 s) for excess removal, then fully light-cured 20 s per surface.
Group 3 (SARC): RelyX™ Universal Resin Cement (3M) - tooth cleaned with pumice and water, rinsed, dried; cement loaded, crown seated, tack-cured 2-3 s, excess removed, full light-curing 20 s per surface.
All crowns are placed by a single calibrated pediatric dentist. Post-cementation periapical radiographs verify marginal integrity. Parents receive standardized oral hygiene instructions and a 7-day course of 0.12% chlorhexidine mouthwash.
Follow-Up and Safety:
Clinical evaluations occur at baseline, 12, 24, and 36 months. Retention is assessed by visual/tactile examination with a sharp explorer and LED transillumination (DEXIS CariVu®). Failed crowns are recemented and excluded from subsequent analyses. Adverse events including soft-tissue irritation, crown fracture, debonding, and aspiration risk are continuously recorded.
Statistical Methodology:
Sample size was calculated using G*Power 3.1.9.7 assuming a medium effect size (f = 0.25) for ANOVA, 90% power, and α = 0.05, yielding 28 participants per group; this was inflated to 40 per group (total 120) to accommodate an anticipated 30% attrition over 36 months. The primary retention outcome will be analyzed by Kaplan-Meier survival analysis with between-group comparison using the log-rank test, supplemented by Fisher's exact test for proportional retention and Cox proportional hazards regression for hazard ratios. Gingival Index and Plaque Index will be compared between groups by one-way ANOVA and within groups by repeated-measures ANOVA. Margin discoloration distribution will be compared by chi-square (with Cramér's V as effect size) and within-group transitions by McNemar's test. Significance is set at p < 0.05. Analyses will follow an intention-to-treat principle, with per-protocol sensitivity analyses.
- Conditions
- Dental Caries, Tooth Injuries, Primary Tooth Restoration
- Being tested
- Cementation with Fuji IX GP Extra Glass Ionomer Cement, Cementation with BioCem™ Universal BioActive Cement, Cementation with RelyX™ Universal Resin Cement
- Keywords
- Prefabricated Zirconia Crown, Luting Cement, Glass Ionomer Cement, Bioactive Cement, Self-Adhesive Resin Cement, Crown Retention
- Medical subject headings
- Dental Caries, Tooth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cementation with Fuji IX GP Extra Glass Ionomer CementProcedure or surgery
Cementation with Fuji IX GP Extra Glass Ionomer Cement Hand-mixed conventional glass ionomer luting cement applied per manufacturer protocol; crown seated under finger pressure for 3 minutes; excess removed after initial set.
Cementation with BioCem™ Universal BioActive CementProcedure or surgery
Cementation with BioCem™ Universal BioActive Cement Auto-mixed bioactive resin-modified luting cement applied per manufacturer protocol; brief tack-cure to facilitate excess removal followed by full light-curing for 20 seconds per surface.
Cementation with RelyX™ Universal Resin CementProcedure or surgery
Cementation with RelyX™ Universal Resin Cement Self-adhesive dual-cure resin luting cement applied per manufacturer protocol; tack-cured for 2-3 seconds for excess removal, followed by full light-curing for 20 seconds per surface.
| Study group | Role | What they receive |
|---|---|---|
| Glass Ionomer Cement (GIC) Group | Active comparator | Glass Ionomer Cement (GIC) Group: Participants receive a NuSmile® prefabricated zirconia crown cemented with conventional glass ionomer cement (Fuji IX GP Extra, GC America) following a standardized polyacrylic-acid-conditioning protocol. Receives: Procedure: Cementation with Fuji IX GP Extra Glass Ionomer Cement |
| Bioactive Resin-Modified Glass Ionomer Cement (BioCem™) Group | Experimental | Bioactive Resin-Modified Glass Ionomer Cement (BioCem™) Group: Participants receive an identical NuSmile® prefabricated zirconia crown cemented with BioCem™ Universal BioActive Cement (NuSmile®, Houston, TX, USA). Receives: Procedure: Cementation with BioCem™ Universal BioActive Cement |
| Self-Adhesive Resin Cement (SARC) Group | Experimental | Self-Adhesive Resin Cement (SARC) Group: Participants receive an identical NuSmile® prefabricated zirconia crown cemented with RelyX™ Universal Resin Cement (3M). Receives: Procedure: Cementation with RelyX™ Universal Resin Cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crown Retention (Survival)
The primary outcome is the cumulative retention of prefabricated zirconia crowns over a 36-month follow-up period. Retention is assessed by a single blinded examiner at each scheduled visit using two complementary methods: (a) visual/tactile inspection with a sharp dental explorer applied circumferentially along the crown margin to detect dislodgement, mobility, or marginal gap; and (b) LED transillumination using the DEXIS CariVu® system to detect cracks, debonding, or marginal microleakage. A crown is classified as "failed" (debonded) if any complete loss of cement seal, dislodgement, or detectable marginal gap is observed. Retention is reported as the proportion of crowns surviving at each time point and as the time-to-failure for survival analysis. Higher retention proportions and longer survival times indicate better clinical performance.
Measured: Baseline, 12, 24, and 36 months post-cementation
Secondary outcomes (3)
Plaque Accumulation Measured by the Silness & Löe Plaque Index (1964)
Plaque accumulation at the gingival margin of each cemented crown is assessed using the Silness \& Löe Plaque Index. The same four sites per tooth (mesial, distal, buccal, lingual) are scored by a blinded examiner on a 4-point ordinal scale: 0 = no plaque; 1 = a film of plaque adhering to the free gingival margin, recognizable only by running a probe across the surface; 2 = moderate accumulation of soft deposits visible to the naked eye; 3 = abundance of soft matter. A mean PI score is calculated per tooth and per participant; the participant-level mean ranges from a minimum of 0 to a maximum of 3, with higher scores indicating greater plaque accumulation.
Measured: Baseline, 12, 24, and 36 months post-cementation
Gingival Health Measured by the Löe Gingival Index (1967)
Gingival inflammation around each cemented crown is assessed at baseline and at every follow-up visit using the Löe Gingival Index (1967). A single blinded examiner scores four gingival sites per tooth (mesial, distal, buccal, and lingual) on a 4-point ordinal scale: 0 = no clinical inflammation (normal gingiva); 1 = mild inflammation (slight color change, slight edema, no bleeding on probing); 2 = moderate inflammation (redness, edema, glazing, bleeding on probing); 3 = severe inflammation (marked redness and edema, ulceration, tendency to spontaneous bleeding). A mean GI score is calculated per tooth and per participant; the participant-level mean therefore ranges from a minimum of 0 to a maximum of 3, with higher scores indicating worse gingival health.
Measured: Baseline, 12, 24, and 36 months post-cementation
Marginal Discoloration Measured by the Modified United States Public Health Service (USPHS) Criteria
Discoloration at the crown-tooth interface is evaluated under standardized LED operatory lighting (1,000-1,400 lux) without magnification using the modified USPHS criteria, supplemented by high-resolution intraoral photography with cross-polarized filters. Each crown is assigned one of four ordinal ratings: Alpha (A) = no visible discoloration (best outcome); Bravo (B) = slight discoloration confined to the margin, not penetrating internally; Charlie (C) = obvious discoloration penetrating along the margin; Delta (D) = severe discoloration with secondary caries or restoration failure (worst outcome). The outcome is reported as the proportion of crowns in each category at each time point, with a higher proportion of Alpha ratings indicating better marginal integrity.
Measured: Baseline (immediately post-cementation), 12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start12 May 2026
- Primary completionJun 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murad Alrashidi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murad Alrashidi, Qassim University
- Investigators
- MURAD ALRASHIDI, BDS, MSC, Principal investigator, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611734
- Sponsor's protocol ID
- 26-19-6
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share de-identified individual participant data underlying the results reported in the final publication. Shared data may include retention status at each time point, time-to-failure, Gingival Index and Plaque Index scores, USPHS marginal discoloration ratings, and adverse event records. The study protocol and statistical analysis plan will also be made available.
Publications
Leuciuc FV, Petrariu I, Pricop G, Rohozneanu DM, Popovici IM. Toward an Anthropometric Pattern in Elite Male Handball. Int J Environ Res Public Health. 2022 Feb 28;19(5):2839. doi: 10.3390/ijerph19052839.
PubMed 35270532Wu M, Liu X, Li Z, Huang X, Guo H, Guo X, Yang X, Li B, Xuan K, Jin Y. SHED aggregate exosomes shuttled miR-26a promote angiogenesis in pulp regeneration via TGF-beta/SMAD2/3 signalling. Cell Prolif. 2021 Jul;54(7):e13074. doi: 10.1111/cpr.13074. Epub 2021 Jun 7.
PubMed 34101281
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Self-Adhesive Resin, Conventional Glass Ionomer, and Bioactive Resin-Modified Glass Ionomer Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07611734
- Acronym / sponsor ID
- 26-19-6
- Conditions
- Dental Caries, Tooth Injuries, Primary Tooth Restoration
- Keywords
- Prefabricated Zirconia Crown, Luting Cement, Glass Ionomer Cement, Bioactive Cement, Self-Adhesive Resin Cement, Crown Retention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Murad AlrashidiUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 28 May 2026 (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 clinical trial is to compare the long-term clinical performance of three different luting cements used to bond prefabricated zirconia crowns (PZCs) on primary front teeth in young children. The trial will determine whether any single cement offers superior retention, gum health, or marginal sealing compared to the others over a 3-year period.
Main Questions:
The study aims to answer the following:
Are conventional glass ionomer cement (GIC), bioactive resin-modified glass ionomer cement (BioCem™), and self-adhesive resin cement (SARC) equivalent in retaining prefabricated zirconia crowns on primary incisors over 36 months? Do these cements differ in their effect on gingival health, plaque accumulation, or marginal discoloration around the cemented crown?
Comparison:
Researchers will compare three parallel groups of children whose primary incisors are restored with identical prefabricated zirconia crowns but cemented with one of the three different luting cements.
Participants will: Receive a clinical and radiographic dental examination at screening. Undergo placement of one or more prefabricated zirconia crowns on primary anterior teeth using their randomly assigned cement. Return to the clinic for blinded follow-up evaluations at 12, 24, and 36 months for assessment of crown retention, gingival health, plaque, and marginal staining.
Detailed description
This prospective, parallel-group, three-arm, randomized controlled trial evaluates the long-term clinical performance of three commercially available luting cements when used to bond prefabricated zirconia crowns (PZCs) on primary anterior teeth in pediatric patients. Although PZCs are increasingly preferred over stainless steel crowns for anterior restorations due to their superior esthetics and biocompatibility, their retention relies entirely on the luting cement because of their passive fit and conservative preparation design. Comparative clinical evidence on cement performance in this specific anatomical and functional context remains limited.
Trial Design:
The trial is conducted at the Pediatric Dental Clinic of Qassim University, Riyadh, Saudi Arabia. Eligible children aged 2 to 7 years requiring full-coverage restoration of one or more primary incisors are randomized in a 1:1:1 ratio to one of three cement groups using a computer-generated randomization sequence. Allocation labels are reshuffled after each assignment to preserve equal group sizes. An independent outcome assessor is blinded to group allocation throughout the trial, and standardized cheek retractors are used to mask cement margins during evaluations. Operators cannot be blinded due to material-specific application protocols.
Intervention Protocols:
Tooth preparation follows standardized anterior-specific minimal reduction principles (1.0-1.5 mm incisal, 0.5-0.8 mm uniform labial, feather-edge proximal margins) under rubber dam isolation. NuSmile® prefabricated zirconia crowns are used for all participants. Cement application follows manufacturer instructions for each group:
Group 1 (GIC): Fuji IX GP Extra (GC America) - tooth conditioned with 20% polyacrylic acid for 20 seconds, rinsed, gently air-dried; cement hand-mixed, loaded into crown, seated under finger pressure for 3 minutes.
Group 2 (BioCem™): BioCem™ Universal BioActive Cement (NuSmile®) - tooth cleaned with pumice and water, rinsed, dried; cement auto-mixed into crown, seated, briefly light-cured (2-3 s) for excess removal, then fully light-cured 20 s per surface.
Group 3 (SARC): RelyX™ Universal Resin Cement (3M) - tooth cleaned with pumice and water, rinsed, dried; cement loaded, crown seated, tack-cured 2-3 s, excess removed, full light-curing 20 s per surface.
All crowns are placed by a single calibrated pediatric dentist. Post-cementation periapical radiographs verify marginal integrity. Parents receive standardized oral hygiene instructions and a 7-day course of 0.12% chlorhexidine mouthwash.
Follow-Up and Safety:
Clinical evaluations occur at baseline, 12, 24, and 36 months. Retention is assessed by visual/tactile examination with a sharp explorer and LED transillumination (DEXIS CariVu®). Failed crowns are recemented and excluded from subsequent analyses. Adverse events including soft-tissue irritation, crown fracture, debonding, and aspiration risk are continuously recorded.
Statistical Methodology:
Sample size was calculated using G*Power 3.1.9.7 assuming a medium effect size (f = 0.25) for ANOVA, 90% power, and α = 0.05, yielding 28 participants per group; this was inflated to 40 per group (total 120) to accommodate an anticipated 30% attrition over 36 months. The primary retention outcome will be analyzed by Kaplan-Meier survival analysis with between-group comparison using the log-rank test, supplemented by Fisher's exact test for proportional retention and Cox proportional hazards regression for hazard ratios. Gingival Index and Plaque Index will be compared between groups by one-way ANOVA and within groups by repeated-measures ANOVA. Margin discoloration distribution will be compared by chi-square (with Cramér's V as effect size) and within-group transitions by McNemar's test. Significance is set at p < 0.05. Analyses will follow an intention-to-treat principle, with per-protocol sensitivity analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glass Ionomer Cement (GIC) Group | Active comparator | Procedure: Cementation with Fuji IX GP Extra Glass Ionomer CementGlass Ionomer Cement (GIC) Group: Participants receive a NuSmile® prefabricated zirconia crown cemented with conventional glass ionomer cement (Fuji IX GP Extra, GC America) following a standardized polyacrylic-acid-conditioning protocol. |
| Bioactive Resin-Modified Glass Ionomer Cement (BioCem™) Group | Experimental | Procedure: Cementation with BioCem™ Universal BioActive CementBioactive Resin-Modified Glass Ionomer Cement (BioCem™) Group: Participants receive an identical NuSmile® prefabricated zirconia crown cemented with BioCem™ Universal BioActive Cement (NuSmile®, Houston, TX, USA). |
| Self-Adhesive Resin Cement (SARC) Group | Experimental | Procedure: Cementation with RelyX™ Universal Resin CementSelf-Adhesive Resin Cement (SARC) Group: Participants receive an identical NuSmile® prefabricated zirconia crown cemented with RelyX™ Universal Resin Cement (3M). |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children aged 2 to 7 years
- One or more primary maxillary or mandibular incisors requiring full-coverage restoration due to caries or trauma
- Adequate remaining tooth structure following preparation, defined as greater than 50% of the clinical crown
- Parent or legal guardian able and willing to provide written informed consent and to commit to the 36-month follow-up schedule
Key exclusion criteria (6 listed)
- Active periodontal disease at the index tooth, defined as a Löe Gingival Index score of 2 or higher
- Parafunctional habits such as bruxism, severe thumb-sucking, or tongue-thrust documented at screening
- Known allergy or hypersensitivity to zirconia, resin, glass ionomer, or any component of the assigned cement
- Inconsistent oral hygiene, defined as less than twice-daily toothbrushing per parental report
- Systemic disease affecting bone metabolism, tooth development, or wound healing
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 |
|---|---|---|
| Cementation with Fuji IX GP Extra Glass Ionomer CementCementation with Fuji IX GP Extra Glass Ionomer Cement Hand-mixed conventional glass ionomer luting cement applied per manufacturer protocol; crown seated under finger pressure for 3 minutes; excess removed after initial set. | Procedure or surgery | Glass Ionomer Cement (GIC) Group |
| Cementation with BioCem™ Universal BioActive CementCementation with BioCem™ Universal BioActive Cement Auto-mixed bioactive resin-modified luting cement applied per manufacturer protocol; brief tack-cure to facilitate excess removal followed by full light-curing for 20 seconds per surface. | Procedure or surgery | Bioactive Resin-Modified Glass Ionomer Cement (BioCem™) Group |
| Cementation with RelyX™ Universal Resin CementCementation with RelyX™ Universal Resin Cement Self-adhesive dual-cure resin luting cement applied per manufacturer protocol; tack-cured for 2-3 seconds for excess removal, followed by full light-curing for 20 seconds per surface. | Procedure or surgery | Self-Adhesive Resin Cement (SARC) Group |
Primary outcome
Crown Retention (Survival)
Time frame: Baseline, 12, 24, and 36 months post-cementation
The primary outcome is the cumulative retention of prefabricated zirconia crowns over a 36-month follow-up period. Retention is assessed by a single blinded examiner at each scheduled visit using two complementary methods: (a) visual/tactile inspection with a sharp dental explorer applied circumferentially along the crown margin to detect dislodgement, mobility, or marginal gap; and (b) LED transillumination using the DEXIS CariVu® system to detect cracks, debonding, or marginal microleakage. A crown is classified as "failed" (debonded) if any complete loss of cement seal, dislodgement, or detectable marginal gap is observed. Retention is reported as the proportion of crowns surviving at each time point and as the time-to-failure for survival analysis. Higher retention proportions and longer survival times indicate better clinical performance.
3 secondary outcomes
Plaque Accumulation Measured by the Silness & Löe Plaque Index (1964)
Time frame: Baseline, 12, 24, and 36 months post-cementation
Gingival Health Measured by the Löe Gingival Index (1967)
Time frame: Baseline, 12, 24, and 36 months post-cementation
Marginal Discoloration Measured by the Modified United States Public Health Service (USPHS) Criteria
Time frame: Baseline (immediately post-cementation), 12, 24, and 36 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 13 Oct 2026.
- Background: PubMed 35270532Leuciuc FV, Petrariu I, Pricop G, Rohozneanu DM, Popovici IM. Toward an Anthropometric Pattern in Elite Male Handball. Int J Environ Res Public Health. 2022 Feb 28;19(5):2839. doi: 10.3390/ijerph19052839.
- Background: PubMed 34101281Wu M, Liu X, Li Z, Huang X, Guo H, Guo X, Yang X, Li B, Xuan K, Jin Y. SHED aggregate exosomes shuttled miR-26a promote angiogenesis in pulp regeneration via TGF-beta/SMAD2/3 signalling. Cell Prolif. 2021 Jul;54(7):e13074. doi: 10.1111/cpr.13074. Epub 2021 Jun 7.
- Individual participant dataSharing planned: Yes. The investigators will share de-identified individual participant data underlying the results reported in the final publication. Shared data may include retention status at each time point, time-to-failure, Gingival Index and Plaque Index scores, USPHS marginal discoloration ratings, and adverse event records. The study protocol and statistical analysis plan will also be made available.
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.
MURAD ALRASHIDI, BDS, MSC principal investigator
Qassim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cementation with Fuji IX GP Extra Glass Ionomer Cement, Cementation with BioCem™ Universal BioActive Cement and Cementation with RelyX™ Universal Resin Cement in people with Dental Caries and Tooth Injuries, run by Murad Alrashidi at 1 site in Saudi Arabia.
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 4 inclusion and 6 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 13 Oct 2026. 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 Saudi Arabia. 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?
Crown Retention (Survival) (time frame: Baseline, 12, 24, and 36 months post-cementation). 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 NCT07611734, which also lists 2 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 13 Oct 2026.