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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04375839
Other study ID # SVSIDS/PERIO/1/2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 6, 2020
Est. completion date November 2021

Study information

Verified date May 2020
Source SVS Institute of Dental Sciences
Contact R V Chandra, MDS;DNB;PhD
Phone 9908183071
Email viswachandra@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date November 2021
Est. primary completion date September 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 44 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Zirconia implant
Following standard surgical protocol, Zirconia implant will be placed in horizontally deficient ridge.
Titanium implant
Following standard surgical protocol, Titanium implant will be placed in horizontally deficient ridge.

Locations

Country Name City State
India SVS Institute of Dental Sciences Hyderabad Telangana

Sponsors (1)

Lead Sponsor Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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