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Zirconia Vs Titanium Implants in Deficient Ridges

Primary Purpose

Alveolar Bone Loss, Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Zirconia implant
Titanium implant
Sponsored by
SVS Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

25 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Based on the classification of alveolar ridge width given by Tolstunov, subjects with

  • partially edentulous (2/3 teeth missing)
  • systemically healthy subjects within the age group of 25-44 years
  • Class III ridges characterized by moderate i.e., 4-6mm of alveolar ridge width will be included.

Exclusion Criteria:

  • Medically compromised patients

    -. Subjects who underwent radiotherapy or chemotherapy and with

  • Habit of smoking, tobacco and alcohol abuse
  • Subjects with active periodontal disease to residual dentition and lack of oral hygiene will be excluded from this study.

Sites / Locations

  • SVS Institute of Dental SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Main treatment group

Control group

Arm Description

Zirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group.

Titanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group.

Outcomes

Primary Outcome Measures

Evaluation of the soft tissue around single implant crowns
Pink Esthetic Score (0-2; increasing scores means improvement in clinical outcomes) is used to evaluate the soft tissue around single implant crowns that might change over time at 3 months and 6 months.
Peri-implant bone resorption
measured in terms of vertical bone levels present mesial and distal to implant which will be measured by comparing CBCT

Secondary Outcome Measures

Implant survival rate
Implant survival rate before and after prosthetic loading based on Criteria: A) Persistent pain or dysesthesia B) Peri-implant infection with suppuration C) Absence of mobility D) Absence of continuous peri-implant radiolucency, but with peri-implant bone resorption assessed using dichotomous scale.

Full Information

First Posted
April 29, 2020
Last Updated
May 5, 2020
Sponsor
SVS Institute of Dental Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04375839
Brief Title
Zirconia Vs Titanium Implants in Deficient Ridges
Official Title
Zirconia Vs Titanium Implants in Horizontally Deficient Ridges - A Clinical and Radiographic Outcome-Based Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to evaluate clinically and radiographically soft tissue around single-implant crowns and peri-implant bone resorption respectively by using zirconia implants or titanium implants in horizontally deficient partially edentulous ridges.
Detailed Description
Experimental: Main treatment group Zirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group. Active Comparator: Control group Titanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main treatment group
Arm Type
Experimental
Arm Description
Zirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Titanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group.
Intervention Type
Device
Intervention Name(s)
Zirconia implant
Other Intervention Name(s)
Experimental group
Intervention Description
Following standard surgical protocol, Zirconia implant will be placed in horizontally deficient ridge.
Intervention Type
Device
Intervention Name(s)
Titanium implant
Other Intervention Name(s)
Control group
Intervention Description
Following standard surgical protocol, Titanium implant will be placed in horizontally deficient ridge.
Primary Outcome Measure Information:
Title
Evaluation of the soft tissue around single implant crowns
Description
Pink Esthetic Score (0-2; increasing scores means improvement in clinical outcomes) is used to evaluate the soft tissue around single implant crowns that might change over time at 3 months and 6 months.
Time Frame
Baseline to 6 months
Title
Peri-implant bone resorption
Description
measured in terms of vertical bone levels present mesial and distal to implant which will be measured by comparing CBCT
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Implant survival rate
Description
Implant survival rate before and after prosthetic loading based on Criteria: A) Persistent pain or dysesthesia B) Peri-implant infection with suppuration C) Absence of mobility D) Absence of continuous peri-implant radiolucency, but with peri-implant bone resorption assessed using dichotomous scale.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Based on the classification of alveolar ridge width given by Tolstunov, subjects with partially edentulous (2/3 teeth missing) systemically healthy subjects within the age group of 25-44 years Class III ridges characterized by moderate i.e., 4-6mm of alveolar ridge width will be included. Exclusion Criteria: Medically compromised patients -. Subjects who underwent radiotherapy or chemotherapy and with Habit of smoking, tobacco and alcohol abuse Subjects with active periodontal disease to residual dentition and lack of oral hygiene will be excluded from this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R V Chandra, MDS;DNB;PhD
Phone
9908183071
Email
viswachandra@hotmail.com
Facility Information:
Facility Name
SVS Institute of Dental Sciences
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
509002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R V Chandra, MDS;DNB;PhD
Phone
9908183071
Email
viswachandra@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Zirconia Vs Titanium Implants in Deficient Ridges

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