Effect of Different Types of Crowns on Patient Satisfaction and Clinical Assesment

NCT02929173 | Unknown Phase 2 DMC

• 1 other identifier: CEBD-CU-2016-09-217
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the patient satisfaction and clinical assessment (shade matching, surface texture and marginal discoloration) of Bio- High Performance Polymers (HPP) restoration versus E-max restoration compared to contralateral tooth in anterior zone. Regardless E-max popularity in the dental field.

Conditions

Personal Satisfaction

Outcome Measures

Primary Outcomes (1)

• Change in esthetic patient satisfaction

  using Rating scores from 0-2 (0= Poor, 1=Accepted, 2=Excellent)

  At crown delivery time and after delivery 3, 6, 9, 12 month

Secondary Outcomes (3)

• Shade match to contralateral tooth

  At crown delivery time and after delivery 3, 6, 9, 12 month

• Marginal discolouration

  At crown delivery time and after delivery 3, 6, 9, 12 month

• Surface texture

  At crown delivery time and after delivery 3, 6, 9, 12 month

Study Arms (2)

Group 2

ACTIVE COMPARATOR

E-max is un allceram crown

Other: Allceram

Group 1

EXPERIMENTAL

Bio HPP crown is a hybrid crown

Other: hybrid crown

Interventions

Allceram OTHER

Pressed E-max coping veneered with E-max veneering system

Also known as: Prosthetic Crown

Group 2

hybrid crown OTHER

pressed Bio HPP coping veneered with visolign veneering system

Also known as: Prosthetic Crown

Group 1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient will be able to physically and psychologically to tolerate conventional restorative procedures.
• Patients have no active periodontal or pulpal diseases, have teeth with good restorations.
• Patient with anterior tooth with problems indicated for full coverage restoration (e.g. mild to moderate discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth) Patients are willing to return for follow-up examination and evaluation.
• Patient with sound contralateral tooth to the selected tooth required for full coverage.
• Patient with root canal treated tooth requiring full coverage restoration

You may not qualify if:

• Patient in the growth stage with partially erupted teeth.
• Patient with poor oral hygiene and motivation.
• Pregnant women's.
• Patient with psychiatric problems or unrealistic expectations.
• Patients have no opposing occluding dentition in the area intended for restoration.
• Patients with parafunctional habits.
• Color blindness patients are excluded.
• Patient without contralateral tooth to that tooth to will be restored.
• Patient without adjacent teeth to that tooth will be restored.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Personal Satisfaction

Interventions

AllCeram

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of fixed prosthodontic department,MTI university

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 11, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 11, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share