Trials Sponsors Conditions Drugs Pricing

Conditions

Dental Implants,Peri-implantitis,Smoking

Outcome Measures

Primary Outcomes (1)

marginal bone loss
Standardized periapical radiographs will be used to assess changes in radiographic bone height.
6 months and 18 months after implantation.

Secondary Outcomes (3)

Implants probing depth (IPD)
4 months, 6 months and 16 months after implantation
Bleeding on probing
4 months, 6 months and 16 months after implantation
Labial gingival recession
4 months, 6 months and 16 months after implantation

Other Outcomes (1)

Implant stability
Immediatly after implant installation (day 0) and 4 months after implantation

Study Arms (2)

Heavy smoker patients

EXPERIMENTAL

Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.

Device: Neo dental implant Alpha Bio Tec. Ltd.

non Smokers patients

ACTIVE COMPARATOR

Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.

Device: Neo dental implant Alpha Bio Tec. Ltd.

Interventions

Neo dental implant Alpha Bio Tec. Ltd.Device

Neo dental implant is used to restore missing teeth

Heavy smoker patientsnon Smokers patients

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age between 20 - 85 years.
Written informed consent.

Sponsors & Collaborators

Rambam Health Care Campus
Otherlead

Study Sites (1)

Rambam Hospital

Haifa, Israel

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

Hadar Zigdon, DMD
Rambam Health Care Campus
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

December 5, 2018

Study Start

January 22, 2019

Actual (reported)

Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Clinical Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (2)

Heavy smoker patients

non Smokers patients

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (2)

Heavy smoker patients

non Smokers patients

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations