Effect of Different Types Crowns on Bio Compatibility and Biological Tissue Response

NCT02929199 | Completed DMC

• 1 other identifier: CEBD-CU-2016-09-218
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study compare soft tissue reaction (bleeding, gingival color and texture), bacteria type and count in the gingival sulcus around the restoration margin and sulcus depth of Bio-compatible High performance polymer( Bio-Hpp) restorations to E-max regardless its popularity in the dental field.

Conditions

Personal Satisfaction

Outcome Measures

Primary Outcomes (1)

• change in patient satisfaction(bleeding)

  presence or absence of bleeding is noted in questionnaire.

  3,6,9 and 12 months

Secondary Outcomes (2)

• Clinical biological outcome(crevice depth)

  before preparation, immediately after crown delivery, 3, 6, 9 and 12 months

• Clinical biological outcome(Bacteria count)

  before preparation, immediately after crown delivery, 3, 6, 9 and 12 months

Study Arms (2)

group A

ACTIVE COMPARATOR

Pressable E- max, an all ceramic crown

Other: All ceramic crown

Group B

EXPERIMENTAL

BIO-Hpp hybrid crown

Other: Hybrid crown

Interventions

All ceramic crown OTHER

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

Also known as: Prosthetic crown

group A

Hybrid crown OTHER

pressed Bio HPP veneered with Visio-Lign Veneering system

Also known as: Prosthetic crown

Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range of patients will be 20-40 years old, able to read and sign the informed consent document.
• Patient will be able to physically and psychologically to tolerate conventional restorative procedures.
• Patients have no active periodontal or pulpal diseases, no pockets, bone defects or resorption, have teeth with good restorations.
• Patients with good Occlusion no para-functional habits
• Patient with teeth with problems indicated for full coverage restoration (e.g. mild to moderate dislocation, 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.
• Patients with periodontal disease, bony defects.
• Pregnant women's.
• Patient with psychiatric problems or unrealistic expectations.
• Patients have no opposing occluding dentition in the area intended for restoration.
• Patients with MalOcclusion and Parafunctional habits.
• smokers

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Hisham Alansary, Professor

  affiliated

  PRINCIPAL INVESTIGATOR

• Ahmed Nagiub, Professor

  Affiliated

  PRINCIPAL INVESTIGATOR

• Maha Taymour, associate Professor

  affliliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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,Fixed Prosthodontic department,MTI University

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 11, 2016
• Study Start: December 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: August 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)