Bone Level Tapered Multi-Center Study

NCT ID: NCT02569671

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2025-09-30

Brief Summary

The aim of this randomized, controlled, multi-center study is to assess the clinical and radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate implantation following extraction of a tooth in the pre-molar and anterior region of the maxilla and mandible (test) compared to the outcomes of placing this implant in healed sites (control).

Detailed Description

The primary objective is to demonstrate that the change in mean peri-implant marginal bone level changes (mesial and distal) from loading to 12 months post-loading of the test treatment will not be worse than the control treatments.

The secondary objectives of the study are to assess differences in clinical and radiographic outcomes between the test and control treatments at 12 months post-loading by looking at implant success and survival, buccal bone dimensional changes, implant stability, soft tissue changes, subject satisfaction, and adverse events.

An additional objective is to assess long-term differences in clinical and radiographic outcomes, as measured in the primary and secondary objectives, over the span of two, three, four, and five years.

Conditions

Tooth Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate Placement - Test

Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.

Group Type: OTHER

Straumann Bone Level Tapered Implant - Immediate Placement

Intervention Type: DEVICE

Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.

Delayed Placement - Control

Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.

Group Type: OTHER

Straumann Bone Level Tapered Implant - Delayed Placement

Intervention Type: DEVICE

Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.

Interventions

Straumann Bone Level Tapered Implant - Immediate Placement

Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.

Intervention Type: DEVICE

Straumann Bone Level Tapered Implant - Delayed Placement

Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must have voluntarily signed the informed consent form before any study related procedures
• Subjects must be males or females who are a minimum of 18 years of age
• Subjects who are in need of a single tooth extraction in the pre-molar or anterior region of the maxilla or mandible (ADA tooth positions 4-13 and 20-29) and replacement with a dental implant.
• Implants must be placed either immediately in an extraction socket or placed in a healed site (greater than 4 months healing) which has not been previously grafted.
• Planned site for implant must have a natural tooth both mesially and distally in the adjacent tooth positions
• Subjects must have opposing dentition (natural teeth, fixed or removable restorations)
• There must be sufficient bone at the implant site to achieve primary stability
• Subjects must be committed to the study and the required follow-up visits
• Subjects must be in good general health as assessed by the Investigator

Exclusion Criteria

• Subjects with a systemic disease that would preclude dental implant surgery
• Subjects with any contraindications for oral surgical procedures
• Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site
• Subjects with a history of local irradiation therapy in the head/neck area
• Subjects with any untreated endodontic lesions or untreated periodontal disease adjacent to the implant site
• Subjects receiving, or having a history of receiving, intravenous or subcutaneous antiresorptive agents, such as bisphosphonates
• Subjects with severe bruxing, parafunctional habits, or temporomandibular joint dysfunction
• Any implant sites where there will be a buccal dehiscence greater than 3 mm or there will be a fenestration of the implant
• Subjects with inadequate oral hygiene or who are unmotivated for adequate home care
• Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
• Subjects who are pregnant or intending to become pregnant during the duration of the study
• Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew tobacco
• Subjects who abuse alcohol or drugs
• Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study
• Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David L. Cochran, DDS, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

UCLA School of Dentistry

Los Angeles, California, United States

Center for Implant Dentistry, University of Florida

Gainesville, Florida, United States

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CR 01/14

Identifier Type: -

Identifier Source: org_study_id