Bone Level Tapered Multi-Center Study

NCT02569671 | Completed Results FDA Device

• 1 other identifier: CR 01/14
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

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).

Conditions

Tooth Loss

Keywords

Dental Implants, Single-Tooth

Outcome Measures

Primary Outcomes (1)

• Mean Crestal Bone Level Change

  mean crestal bone level at 12 months - mean crestal bone level at implant loading (baseline) = Change in crestal bone level

  Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading

Secondary Outcomes (8)

• Implant Success and Survival

  12 months post-loading

• Buccal Bone Dimensional Changes

  Measured at Implant loading and at screening and 12 months post-loading

• Implant Measure as Measured by ISQ at Implant Surgery

  Implant surgery: Immediate Placement for Test Group = implant is placed at the time of tooth extraction. Delayed Placement is Control Group= implant is placed after 16-18 weeks of healing

• Implant Stability as Measured by ISQ at Implant Loading

  Implant Loading=implant surgery + 10 weeks (+/-3 weeks)

• Implant Stability as Measured by ISQ at Final Restoration

  Final Restoration: 10 weeks post-loading (± 2 weeks)

Study Arms (2)

Immediate Placement - Test

OTHER

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

Device: Straumann Bone Level Tapered Implant - Immediate Placement

Delayed Placement - Control

OTHER

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

Device: Straumann Bone Level Tapered Implant - Delayed Placement

Interventions

Straumann Bone Level Tapered Implant - Delayed Placement DEVICE

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

Delayed Placement - Control

Straumann Bone Level Tapered Implant - Immediate Placement DEVICE

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

Immediate Placement - Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (3)

UCLA School of Dentistry

Los Angeles, California, 90095-1668, United States

Location

Center for Implant Dentistry, University of Florida

Gainesville, Florida, 32610-0434, United States

Location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Results Point of Contact

• Title: Angelica Luque Gonzalez
• Organization: Institut Straumann

angelica.luque@straumann.com

0034680383996

Study Officials

• David L. Cochran, DDS, PhD, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 7, 2015
• Study Start: March 1, 2016
• Primary Completion: November 12, 2019
• Study Completion: December 1, 2025
• Last Updated: May 5, 2026
• Results First Posted: July 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)