Zirconia Vs Titanium Implants in Deficient Ridges
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2020
CompletedFirst Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedMay 7, 2020
May 1, 2020
6 months
April 29, 2020
May 5, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Implant survival rate
Baseline to 6 months
Study Arms (2)
Main treatment group
EXPERIMENTALZirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group.
Control group
ACTIVE COMPARATORTitanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group.
Interventions
Following standard surgical protocol, Zirconia implant will be placed in horizontally deficient ridge.
Following standard surgical protocol, Titanium implant will be placed in horizontally deficient ridge.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SVS Institute of Dental Sciences
Hyderabad, Telangana, 509002, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 5, 2020
Study Start
March 6, 2020
Primary Completion
September 1, 2020
Study Completion
November 1, 2021
Last Updated
May 7, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share