Evaluation of Crestal Bone Loss Around Short Dental Impla... | NCT05066815

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

NCT05066815

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jun 10, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Bone Loss

Interventions

Vita Enamic (Hybrid dental ceramic)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2022Estimated

Primary Completion Date

Dec 25, 2022Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Aug 11, 2021

First Submission Date that Met QC Criteria

Sep 22, 2021

First Posted Date

Oct 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2022

Last Update Posted Date

Jun 10, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dina Nabil Ezz Eldin, : Assistant Lecturer of Fixed Prosthodontics, Faculty of Dentistry (Aswan University), Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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:

Selection and examination of the patients according to inclusion and exclusion criteria.
Preoperative Cone Beam Computed Tomography (CBCT) to all patients.
Primary impression will be taken to produce study cast.
Taking a professional photo for the examined posterior area.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hybrid superstructure	Experimental	screw retained hybrid ceramic crowns	Other: Vita Enamic (Hybrid dental ceramic)
Ceramic superstructure	Active Comparator	screw retained lithium disilicate based ceramic crowns	Other: Vita Enamic (Hybrid dental ceramic)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vita Enamic (Hybrid dental ceramic)	Other	Vita Enamic (Hybrid dental ceramic) is provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
Heavy smokers.
Poorly controlled diabetes mellitus.
Patients on radiotherapy.
Patients with temporomandibular disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000621297	VITA Enamic

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided