MedDataX Logo

Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments

NCT ID: NCT01234584

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this present study is to compare alveolar bone changes and markers of gingival health around the new Lanes® dental implant which were rehabilitate using the new switch platform abutment ( SPR ) and the traditional ( CPK ) abutment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Group A- 23 Implant Using Switch Platform -SPK Abutment. Group B- 22 Implant Using the Traditional -CPK Abutment.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

23 implants using SPK Abutments

Group Type EXPERIMENTAL

spk

Intervention Type PROCEDURE

implants using SPK Abutments

Group B

implants using CPK Abutments

Group Type ACTIVE_COMPARATOR

CPK Abutments

Intervention Type PROCEDURE

implants using CPK Abutments

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

spk

implants using SPK Abutments

Intervention Type PROCEDURE

CPK Abutments

implants using CPK Abutments

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adult patient aged 18 - 80 yrs.
2. Implants treatment planned for single crown rehabilitation.
3. Submerged implant placement.
4. Patients willing to participate in a twelve month study.
5. Up to 2 implants per patient will be allowed.

Exclusion Criteria

1. Active periodontal disease.
2. Systemic condition and medication that may affect soft and hard tissue healing.
3. Pregnancy or intention to become pregnant in the next twelve months.
4. Parafunctional occlusal scheme and habits.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Maxillofacial Rehabilitation School of Gradute Dentistry Rambam Health care campus Haifa, Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Maxillofacial Rehabillitaion School of Graduate Dentistry Rambam Health care campus

Haifa, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zvi Gutmacher, DMD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTIL0227-10-RMB

Identifier Type: -

Identifier Source: org_study_id