NCT06575803

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Jul 2024Oct 2027

Study Start

First participant enrolled

July 1, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

2.4 years

First QC Date

July 23, 2024

Last Update Submit

August 26, 2024

Conditions

Keywords

RepressingIps Emax pressceltrapresslisi pressEDAXSEMXRDPatient satisfaction

Outcome Measures

Primary Outcomes (4)

  • 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.

    1 year

  • 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

    1 year

  • 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

    1 year

  • 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).

    1 year

Study Arms (1)

crowns constructed from repressed ceramics

EXPERIMENTAL

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

Other: clinical measurements and evaluation

Interventions

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

Also known as: clinical measurements
crowns constructed from repressed ceramics

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lina Mohamed Mohamed Abdallah Ali Elashry

Ismailia, Ismalia Old University Street, Egypt

Location

Lina Mohamed Mohamed Abdallah Ali Elashry

Cairo, Ismalia, Egypt

Location

MeSH Terms

Conditions

Plaque, AmyloidPatient SatisfactionRoot CariesPain, Postoperative

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehaviorDental CariesTooth DemineralizationTooth DiseasesStomatognathic DiseasesPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: clinical performance of single restorations fabricated for the patients from pressed and repressed ceramics
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principl investigator leena Asahry(Lashry

Study Record Dates

First Submitted

July 23, 2024

First Posted

August 28, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations