Zirconia Vs Titanium Implants in Deficient Ridges

Zirconia Vs Titanium Implants in Horizontally Deficient Ridges - A Clinical and Radiographic Outcome-Based Study

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.

Study Overview

• Status: Unknown
• Conditions: Periodontitis; Alveolar Bone Loss
• Intervention / Treatment: Device: Zirconia implant; Device: Titanium implant

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 509002
      • Recruiting
      • SVS Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main treatment group; Zirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group.	Device: Zirconia implant; Following standard surgical protocol, Zirconia implant will be placed in horizontally deficient ridge.; Other Names: Experimental group
Active Comparator: Control group; Titanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group.	Device: Titanium implant; Following standard surgical protocol, Titanium implant will be placed in horizontally deficient ridge.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 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	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: SVS Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Periodontitis; Alveolar Bone Loss
• Other Study ID Numbers: SVSIDS/PERIO/1/2019

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
• product manufactured in and exported from the U.S.: No