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

June 9, 2022 updated by: Dina Nabil Ezz Eldin, Cairo University
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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: one year
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)
Time Frame: one year
preventive
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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