ClinicalTrials.gg
Active, not recruitingNCT06575803Updated Aug 28, 2024

Recycling of Three Pressable Ceramics With Different Weight Percentage

An interventional study of clinical measurements and evaluation in Plaque, Patient Satisfaction and Caries, Cervical, sponsored by Faculty of Dental Medicine for Girls. Active, not recruiting at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Introduction: Green dentistry, is high-technology approach that reduces the environmental impact of dental practices, improper disposal of dental materials wastes results in environmental hazards.

Aim of the study: This studied will be performed o evaluate the effect of repressing of three different types of pressable ceramics, Ips Emax press, Lisi press and Celtra press with different weight percentages on patient satisfaction, mechanical properties, microstructural features and composition of these pressable ceramics.

Materials \& Methods:

Seventy five ( N=75) pressable ceramic discs will be constructed ,The samples will be divided to three groups (n=25 each) according to types and composition of pressed and repressed ceramics .Group 1: IPS Emax press .Group 2: Gc Lisipress Group 3: Celtrapress . Each group willbe divided into 5 sub-groups (n=5) according to the weight percentage of newly pressed and repressed ceramics. Subgroup A: 100% new ceramics. Subgroup B: 75% new and 25 % repressed ceramic .Subgroup C: 50% new and 50% repressed ceramics. Subgroup D:25%new and 75% repressed ceramics. Subgroup E: 100% repressed ceramics. Biaxial flexural strength will be measured using universal testing machine. X-ray diffraction will be performed to identify the crystalline phases, and a scanning electron microscope will be used to describe microstructural features. Energy dispersive X-ray analysis will be used to evaluate change in composition Also surface hardness will be evaluated. Patient satisfaction, plaque, cervical caries and marginal discoloration will be evaluated in a follow- up of one year (in vivo part).

Read the detailed description

Methods:

This study will be divided into two parts: I. In vitro and in vivo studies:

In vitro study

  1. Sample size calculation.
  2. Sample grouping.
  3. Fabrication of the ceramic discs.
  4. Testing procedures.
  5. Statistical analysis

Sample size estimation and statistical power:

ANOVA test was used according to a previous study by Salem et al (2019) (15), the mean values for the fracture strength ranged from 819.366N to 929.724 according to the weight percentage of the newly pressed and repressed ceramics. G power statistical power analysis program (version 3.1.9.2) will be used for sample size calculation . A total sample size of75 (3groups with 5 subgroups, 5 sample in each sub group) will be sufficient to detect a large effect size of 0.52, with an actual power (1-β error) of 0.95(95%) and a significance level (αerror) 0.05 (5%) for two-sided hypothesis test.

Sample preparation In this study, pressable and repressable ceramic discs will be fabricated. Lost wax technique will be used to manufacture disc-shaped ceramic specimens of three types of pressable ceramic.

Sample grouping:

A total of seventy five (N=75) pressable ceramic discs will be fabricated. The samples will be divided to three groups (n=25 each) according types and composition of pressable ceramics that will be used.

Group 1: IPS emax press (pressed and repressed) (n=25) Group 2: Gc Lisipress (pressed and repressed) (n=25) Group 3: Celtrapress (Pressed and repressed) (n=25) Each group will be divided into 5 sub-groups (n=5) according to the weight percentage of newly pressed and repressed ceramics. Subgroup A: Samples will be 100% new ceramics Subgroup B: Samples will be 75% new and 25 %repressed ceramic Subgroup C: Samples will be 50% new and 50% repressed ceramics Subgroup D: samples will be 25% new and 75% repressed ceramics. Subgroup E: Samples will be100% repressed ceramics. Fabrication of the ceramic discs. 3D printed resin specimens will be sprued and invested in a ring system using phosphate bonded investment .The ring will be then placed in a burnout furnace. Ceramic ingots will be plasticized and pressed in its softened state into the hollow place in the investment ring by means of a plunger. After pressing, the pressed discs and sprues will be weighed to calculate the needed weight of ceramic needed for fabrication of the samples. The sprues will be cut.The ceramic that will be repressed will be placed into the opening at the top surface of the investment mold. Ceramic material will be placed in each pressing cycle according to the desired Wt. % of pressed and repressed ceramics

Laboratory steps:

> Fabrication of pressed and repressed ceramic discs,

  1. Construction of resin patterns.
  2. Spruing of resin patterns.
  3. Investing of resin patterns.
  4. Resin elimination.
  5. Pressing.
  6. Divesting.
  7. Finishing and polishing of the discs

Construction of the resin patterns:

A digital design of the disc-shaped specimen; ten millimeters in diameter and one and half millimeter in thickness will be designed by computer-aided design software. The specimen design will be printed by a 3d printer. Seventy-five resin disc specimens will be produced

Spruing of resin patterns:

3d printed resin patterns will be sprued following the manufacturer instructions

Pressing:

  1. Ceramic material will placed in each pressing cycle according to the desired Wt. % of pressed and repressed.

    Resin elimination:

    Resin will be eliminated according to manufacturer recommendations; the investment ring was placed in the burn out furnace.

    Divesting:

    The length of the plunger will be marked on the cold investment ring, then The ring will be separated using a separating disc. Finishing and polishing of the discs Ceramic discs will be finished according to the manufacturer's instructions and polished.

    Thermo mechanical aging:

    Ceramic disc specimens will be subjected to thermo-mechanical aging (thermocycling and cyclic loading) using chewing simulator integrated with thermocycling protocol to simulate a total of 6 months of clinical chewing conditions.

    Testing procedure:

    Flexural strength will be measured using universal testing machine. Vicker hardness and fracture toughness will be determined by indentation technique.

    Scanning electron microscope will be used to evaluate microstructure of pressed and repressed ceramics X-ray diffraction will be used to evaluate the crystalline phase. Energy dispersive X-ray analysis (EDAX) will be used to evaluate change in composition of pressed and repressed ceramic.

    Scanning electron microscope will be used to evaluate microstructure of pressed and repressed ceramics In vivo part II. Case presentation for the groups. All the groups and sub-groups in the vitro part will be evaluated as a case presentation study.

    Part (I): In vivo study:

    Following randomized clinical trial rules 1. Ethical considerations. 2. Patient selection. 3. Pre-operative phase. 4. Operative phase. 5. Laboratory steps. 6. Cementation. 7. Clinical evaluation.

    Ethical considerations:

    The study proposal was approved by the Research Ethics Committee (REC) of the Faculty of Dental Medicine for girls, Al-Azhar University, under code: Code of approval P-CR-24-02.

    Patients will be informed about the characteristics and aim of the study and will sign an Informed consent.

    Subject and selection criteria:

    This study will be conducted on the patient who need single crowns attending the outpatient clinic of the Crowns and Bridges department, Faculty of Dental Medicine for Girls, Al-Azhar University.

    This study will be conducted after obtaining the approval of Research Ethic Committee (REC),Faculty of Dental Medicine for Girls, Al-Azhar University.

    The entire patients will be informed about the purpose of investigation, clinical procedures, benefits and hazards of the applied materials and procedure. Before initiation of the procedure a written informed consent will be signed by the patients. Inclusion Criteria

    • Patients requesting single crowns for mandibular posterior teeth.
    • Mandibular posterior teeth that will be prepared to receive single crowns should have adequate crown root ratio, periodontal support, exhibited minimal mobility and adequate tooth preparation length to ensure proper resistance and retention form .
    • Cooperative patients. Exclusion Criteria Patients with severe periodontitis, gingival inflammation, parafunction and poor oral hygiene or high caries activity will be excluded from the present study.

    Pre- operative phase:

    A complete case history including (chief complain, personal data, dental and medical history) will be taken orally from each patient.

    Also, periapical radiograph of abutment tooth and pre-operative clinical examination will be performed for each patient.

    Diagnostic casts of the maxillary and mandibular arches will be obtained after pouring alginate impression.

    Operative phase:

    A. Preparation. B. Secondary impression. C. Samples grouping

    Preparation:

    Clinical procedures will be performed on either vital or endodontically treated molars.

    Secondary impression:

    Impression will be taken for each case using Addition silicone impression material and will be poured with type V dental stone.

    Samples' grouping:

    ▪ Patients will be divided into 3 groups according to types and composition of pressable ceramics that will be used. Group 1: IPS emax press (pressed and repressed) Group 2: Gc Lisipress (pressed and repressed) Group 3: Celtrapress (pressed and repressed) Each group will be divided into 5 sub-groups according to the weight percentage of newly pressed and repressed ceramics. Subgroup A: Samples will be 100% new ceramics Subgroup B: Samples will be 75% new and 25 %repressed ceramic Subgroup C: Samples will be 50% new and 50% repressed ceramics Subgroup D: Samples will be 25% new and 75% repressed ceramics. Subgroup E: Samples will be 100% repressed ceramics.

    Laboratory steps:

    • Fabrication of pressed ceramic crowns, subgroup (A):

      1. Construction of wax patterns. 2. Spruing of wax patterns. 3. Investing of wax patterns. 4. Wax elimination. 5. Pressing. 6. Divesting. 7. Finishing and glazing

    Construction of the wax patterns:

    The wax patterns will be constructed using CAD/CAM system.

    The CAD/CAM system include the following:

    Acquisition unit that consists of:

    1. A desktop computer connected to Dental Scanner.
    2. Exocad computer software that is responsible for designing the restoration, then imports an STL file to the milling machine.

    Milling Machine: Wax discs will be milled.

    Spruing of wax patterns:

    Following the manufacturer instructions, milled wax patterns will be sprued.

    Pressing:

    Ceramic material will placed in each pressing cycle according to the desired Wt. % of pressed and repressed ceramics.

    Wax elimination:

    Wax will be eliminated according to manufacturer recommendations; the investment ring was placed in the burn out furnace.

    Divesting:

    The length of the plunger will be marked on the cold investment ring, then the ring will be separated using a separating disc.

    Finishing and glazing of restorations:

    According to the manufacturer's instructions, all crowns will be finished and glazed.

    Cementation:

    The single crowns will be cemented in patient mouth.

    Clinical evaluation:

    Clinical performance of all crowns of the studied subgroups in terms of: marginal discoloration, color stability, fracture, patient satisfaction, will be evaluated at base line (1week), 3 and 6 months after cementation.

    Clinical evaluation will be performed according to:

    • Modified United States Health Service (USPHS) Ryge Criteria, at base line (1 week), 3, 6 and 12 months after cementation.
    • The presence of plaque will be evaluated using the Loe and Silness plaque index.
    • Clinical examination will be performed using a mirror and sharp explorer, radiograph and photograph.

      • Patient satisfaction will be evaluated using a questionnaire

    The patient satisfaction:

    Patient satisfaction of each subgroup will be assessed by using Visual Analogue Scale (VAS) which is documented chart in the form of satisfied or unsatisfied. A questionnaire will be used to evaluate restorations at baseline (1 week after cementation), 3 and 6 months.

02

Conditions studied

  • Plaque
  • Patient Satisfaction
  • Caries, Cervical
  • Post Operative Pain

Keywords

  • Repressing
  • Ips Emax press
  • celtrapress
  • lisi press
  • EDAX
  • SEM
  • XRD
  • Patient satisfaction
03

In context

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

This study's planned enrollment of 15 is below the median of 96 across 624 interventional studies indexed under Patient Satisfaction.

Browse Patient Satisfaction studies →

Lead sponsor

Faculty of Dental Medicine for Girls is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients requesting single crowns for mandibular posterior teeth.

  • Mandibular posterior teeth that will be prepared to receive single crowns should have adequate crown root ratio, periodontal support, exhibited minimal mobility and adequate tooth preparation length to ensure proper resistance and retention form .
  • Cooperative patients.

Exclusion criteria

Exclusion Criteria:

  • Patients with severe periodontitis, gingival inflammation, parafunction and poor oral hygiene or high caries activity will be excluded from the present study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    crowns constructed from repressed ceramics

    clinical performance of single restorations fabricated for the patients from pressed and repressed ceramics

    Other: clinical measurements and evaluation

Interventions

  • Otherclinical measurements and evaluation

    clinical performance of single restorations fabricated for the patients from pressed and repressed ceramics

    Also known as: clinical measurements

06

What researchers measure

Primary outcomes

  1. Excellent patient satisfaction, good mechanical properties and microstructure of single crown restorations .

    Clinical evaluation will be performed according to: - Modified United States Health Service (USPHS) Ryge Criteria, at base line (1 week), 3, 6 and12 months after cementation.

    Time frame: 1 year

  2. Quality and strength of the restoration and

    Modified (USPHS) Ryge criteria system was used to evaluate the quality of all crowns. Category Evaluated by Score Criteria Fracture evaluated by Visual inspection with dental explorer Score Alpha (A) No evidence of fracture. Bravo (B) Evidence of fracture Category Evaluated by Score Criteria Fracture evaluated by Visual inspection with dental explorer Score Alpha (A) No evidence of fracture. Bravo (B) Evidence of fracture

    Time frame: 1 year

  3. Good oral hygiene and patient satisfaction

    he presence of plaque will be evaluated using the Loe and Silness plaque index. Score 0= no plaque the tooth surface is clean. Score 1= The tooth surface appears clean ,but dental plaque can be removed from the gingival third with a sharp explorer Score 2= Plaque is visible along the gingival margin to naked eye (moderate accumulation) Score 3=Large amount of plaque in sulcus - Clinical examination will be performed using a mirror and sharp explorer, radiograph and photograph. . Patient satisfaction will be evaluated using a questionnaire The patient satisfaction: Patient satisfaction of each subgroup will be assessed by using Visual Analogue Scale (VAS) which is documented chart in the form of satisfied or unsatisfied. A questionnaire will be used to evaluate restorations at baseline (1 week after cementaton), 3 and 6 months

    Time frame: 1 year

  4. excellent marginal integrity

    Marginal discoloration evaluated by Visual inspection with mirror at 45 degrees angel Score Alpha (A) No discoloration Bravo (B)Superficial staining (removable, usually localized). Charlie (C)Deep staining (not removable, generalized).

    Time frame: 1 year

07

Study locations

2 sites
  • Lina Mohamed Mohamed Abdallah Ali Elashry
    Ismailia, Ismalia Old University Street, Egypt
  • Lina Mohamed Mohamed Abdallah Ali Elashry
    Cairo, Ismalia, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.

Of 368 non-industry interventional studies with no phase under Patient Satisfaction, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 29 months is above that.

Counting every sponsor, half of 370 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2024
First posted
Aug 28, 2024
StartActual
Jul 1, 2024
Primary completionEst.
Dec 2026
CompletionEst.
Oct 2027
Last update
Aug 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06575803
Lead sponsor
Faculty of Dental Medicine for Girls
Responsible party
Leena Ashry (Principl investigator leena Asahry(Lashry, Faculty of Dental Medicine for Girls) — Principal investigator
First posted
Aug 28, 2024
Start date
Jul 1, 2024
Primary completion
Dec 2026 (estimated)
Completion
Oct 2027 (estimated)
Last update
Aug 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion