NCT04375839

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

April 29, 2020

Last Update Submit

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

EXPERIMENTAL

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

Device: Zirconia implant

Control group

ACTIVE COMPARATOR

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

Device: Titanium implant

Interventions

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

Also known as: Experimental group
Main treatment group

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

Also known as: Control group
Control group

Eligibility Criteria

Age25 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Alveolar Bone LossPeriodontitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

R V Chandra, MDS;DNB;PhD

CONTACT

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

Locations