Evaluation of Crestal Bone Loss Around Short Dental Implants As Affected By Two Suprastructure Materials

The aim of the study is to evaluate the crestal bone loss developed around short dental implants after using screw retained Hybrid ceramic crowns when compare to screw retained Lithium Di silicate based ceramic crowns.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Loss
• Intervention / Treatment: Other: Vita Enamic (Hybrid dental ceramic)

Detailed Description

This study will be conducted on patients requiring single implant replacement in the posterior regions of the mandible, admitted to the Outpatient Clinic of Fixed Prosthodontics Department, Faculty of Oral and Dental medicine, Cairo University.

Examination and diagnosis:

1. Selection and examination of the patients according to inclusion and exclusion criteria.
2. Preoperative Cone Beam Computed Tomography (CBCT) to all patients.
3. Primary impression will be taken to produce study cast.
4. Taking a professional photo for the examined posterior area.
5. Patients will be divided into two group:

G1: Short implants will be restored by screw retained Hybrid ceramic crowns G2: Short implants will be restored by screw retained Lithium Di silicate based ceramic crowns

Surgical procedures:

• Implants will be placed following standardized protocol.
• After 4 months the patients re-attended for placement of healing abutments for about (10-14) days and prosthesis fabrication.

Data collection and post operative radio-logical assessment:

-Taking standardized digital peri-apical radio-graph by paralleling technique and film holding device for follow up at 12 months after crowns loading to evaluate crestal bone loss.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients within age group of ≥ 18.
2. There should be absence of any systemic diseases.
3. Patients have missing simple posterior tooth
4. Adequate interarch space.
5. Inadequate residual bone height to place standard length implant.
6. Patients with good oral hygiene.

Exclusion Criteria:

1. A history that would complicate the outcome of the study, such as alcohol or drug dependency, smoking, poor health, or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontics treatment and required follow-up.
2. Heavy smokers.
3. Poorly controlled diabetes mellitus.
4. Patients on radiotherapy.
5. Patients with temporomandibular disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid superstructure; screw retained hybrid ceramic crowns	Other: Vita Enamic (Hybrid dental ceramic); Vita Enamic (Hybrid dental ceramic) is provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology.; Other Names: Polymer Infiltrated Ceramic Network (PICN)
Active Comparator: Ceramic superstructure; screw retained lithium disilicate based ceramic crowns	Other: Vita Enamic (Hybrid dental ceramic); Vita Enamic (Hybrid dental ceramic) is provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology.; Other Names: Polymer Infiltrated Ceramic Network (PICN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crestal Bone Loss Crestal bone loss will be measured using standardized digital periapical radiograph by paralleling technique and film holding device -measuring unit:Milimeters	preventive	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
screw loosening of crowns screw loosening will be observed by clinical investigation -measuring unit:Binary (Yes/No)	preventive	one year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 25, 2022
• Primary Completion (Anticipated): December 25, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: 211020

Drug and device information, study documents

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