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

Evaluation of Bio Compatibility of Bio-HPP Crown Veneered With Visio.Lign Compared to Lithium Disilicate (E-max) Crown Veneered With E-max Veneering System in Anterior Esthetic Zone (Randomized Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Personal Satisfaction
• Intervention / Treatment: Other: All ceramic crown; Other: Hybrid crown

Detailed Description

Roles and responsibilities:

1. Esra'a Mohamed Ali Mraweh (E.M):Operator, data enterer and corresponding author;Assistant lecturer, Fixed Prosthodontics Department, Modern Technology and Information University (MTI University), Egypt.
2. Dr. Hesham Alansary ( H.A):Main supervisor, data monitoring, auditing Professor, Fixed prosthodontics department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
3. Nora Helmy (N.H):Outcome assessors and data collection;Assistant Lecturers, Fixed Prosthodontics department, Faculty of Oral and Dental Medicine, Modern Technology and Information University (MTI university), Egypt.
4. Noha Moustafa (N.M):Base line data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants' consents;Resident, Fixed Prosthodontics Department, Faculty of Oral and Dental Medicine, Modern Technology and Information University (MTI University), Egypt.
5. Eman Desouky (E.D.):Sample size calculation; Statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
6. Evidence Based Dentistry Committee (CEBD): Help in reporting study protocol following SPIRIT guidelines;Faculty of Oral and Dental Medicine, Cairo University, Egypt.
7. Research Ethics Committee (CREC): Protocol reviewer of the clinical trial in order to protect the right, safety, dignity and well-being of the participants.

Faculty of Oral and Dental Medicine, Cairo University, Egypt.

8. Research Plan Committee (CRPC): For ensuring that this clinical trial following the department research plan; Fixed Prosthodontic Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

1. Intervention:E.M. will record the crevice depth and bacterial count prior to preparation. E.M. will perform full coverage conservative tooth preparation following principles of all ceramic crown preparation with shoulder sub-gingival finish line of thickness 1mm using tapered stone with flat end attached to high speed headpiece with air and water coolant after local anesthesia has been given as required.After tooth preparation, E.M will take an adequate 2ry Impression using non aqueous Elastomeric impression materials Impregum™F( medium consistency,3M ESPE) and bite registration, Pink Soft wax(Star dental supply)will be taken. E.M will fabricate the temporary restoration using composite resin temporary material Protemp™4 Temporisation Material (3M ESPE) and cemented using non Eugenol Zinc Oxide temporary cement TempBond™ Temporization( Kerr Dental).

   E.M will deliver pressed Bio-compatible High performance polymer (Bio-HPP) frame work veneered with visio.lign system (Bredent) cemented by a self adhesive resin cement

2. Comparator: E.M. will record the crevice depth and bacterial count prior to preparation. E.M. will perform full coverage conservative tooth preparation following principles of all ceramic crown preparation with shoulder sub-gingival finish line of thickness 1mm using tapered stone with flat end attached to high speed headpiece with air and water coolant after local anesthesia has been given as required.After tooth preparation, E.M will take an adequate 2ry Impression using non aqueous Elastomeric impression materials Impregum™F( medium consistency,3M ESPE) and bite registration, Pink Soft wax(Star dental supply)will be taken. E.M will fabricate the temporary restoration using composite resin temporary material Protemp™4 Temporisation Material (3M ESPE) and cemented using non Eugenol Zinc Oxide temporary cement TempBond™ Temporization( Kerr Dental).

   E.M. will deliver Pres-sable E-max (IPS e.max®) framework will be veneered with e-max veneering system (Ivoclar Vivadent) .The finished crown will be cemented by Self-Adhesive resin Cemen taccording to manufacturer instructions.

3. Outcome:(i)Patient satisfaction (bio-compatibility) measure patient satisfaction using data in questionnaire (presence or absence of bleeding.) The main and standard deviation for the questionnaire of patient at the time crown cementation, 3, 6,9 and 12 months will be recorded.

(ii) Clinical biological outcome:

• measure the Crevice depth using periodontal probe and record the depth in millimeters collected a swap from the teeth and Bacterial count will be measured using culture number of cells per millimeter
• The main and standard deviation for all collected data ,at the time of crown cementation, 3, 6,9 and 12 months will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age range of patients will be 20-40 years old, able to read and sign the informed consent document.
2. Patient will be able to physically and psychologically to tolerate conventional restorative procedures.
3. Patients have no active periodontal or pulpal diseases, no pockets, bone defects or resorption, have teeth with good restorations.
4. Patients with good Occlusion no para-functional habits
5. 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).
6. Patients are willing to return for follow-up examination and evaluation.
7. Patient with sound contralateral tooth to the selected tooth required for full coverage.
8. Patient with root canal treated tooth requiring full coverage restoration

Exclusion Criteria:

1. Patient in the growth stage with partially erupted teeth.
2. Patient with poor oral hygiene and motivation.
3. Patients with periodontal disease, bony defects.
4. Pregnant women's.
5. Patient with psychiatric problems or unrealistic expectations.
6. Patients have no opposing occluding dentition in the area intended for restoration.
7. Patients with MalOcclusion and Parafunctional habits.
8. smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: group A; Pressable E- max, an all ceramic crown	Other: All ceramic crown; Pressed E-Max coping veneered with E-max veneering system; Other Names: Prosthetic crown
EXPERIMENTAL: Group B; BIO-Hpp hybrid crown	Other: Hybrid crown; pressed Bio HPP veneered with Visio-Lign Veneering system; Other Names: Prosthetic crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in patient satisfaction(bleeding)	presence or absence of bleeding is noted in questionnaire.	3,6,9 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical biological outcome(crevice depth)	Crevice depth(mm): measured using Periodontal probe and recorded in millimeters(mm).	before preparation, immediately after crown delivery, 3, 6, 9 and 12 months
Clinical biological outcome(Bacteria count)	Bacterial account: from the culture specimens, the number of bacteria Cells per millimeter was recorded.	before preparation, immediately after crown delivery, 3, 6, 9 and 12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hisham Alansary, Professor, Affiliated; Principal Investigator: Ahmed Nagiub, Professor, Affiliated; Principal Investigator: Maha Taymour, associate Professor, affliliated

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (ESTIMATE): October 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2016-09-218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No