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Completed

NCT Number: NCT02569671

Bone Level Tapered Multi-Center Study

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).

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA School of Dentistry, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Straumann Bone Level Tapered Implant - Immediate Placement

Device

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

Straumann Bone Level Tapered Implant - Delayed Placement

Device

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

Primary outcomes

  1. Mean Crestal Bone Level Change

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

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

Secondary outcomes

  1. Implant Success and Survival

    Time frame: 12 months post-loading

    Control group N-25 Test group N=24

    Survival and success was assessed by the dimensions below as noted by Buser.

    • Absence of persistent subjective complaints, such as pain, foreign body sensation, and/ or dysesthesia
    • Absence of a recurrent peri-implant infection with suppuration
    • Absence of mobility
    • Absence of a continuous radiolucency around the implant

  2. Buccal Bone Dimensional Changes

    Time frame: Measured at Implant loading and at screening and 12 months post-loading

    Buccal bone dimensional changes were measured on images recorded on cone beam computed tomography (CBCT). The average of the following measurement locations is reported as outcome variable:

    • mesial to distal; 2) distal-buccal; 3) mid-buccal; 4) mesial-buccal; 5) distal-lingual; 6) mid-lingual; 7) mesial-lingual.

  3. Implant Measure as Measured by ISQ at Implant Surgery

    Time frame: 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 held facial-lingual and held mesial-lingual.

    An Osstell device that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration was used in the study. The results were presented as an Implant Stability Quotient (ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional information about the Osstell device can be found at www.osstell.com. Instructions on taking the measurements for this protocol will be provided in the Operation Manual. Two measurements were taken from two different angles at implant placement, implant loading, and final restoration.

  4. Implant Stability as Measured by ISQ at Implant Loading

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

    Implant stability was measured by ISQ and probe held facial-lingual and held mesial-lingual.

    An Osstell device is an instrument that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration. The result is presented as an Implant Stability Quotient (ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional information about the Osstell device can be found at www.osstell.com. Instructions on taking the measurements for this protocol will be provided in the Operation Manual. Two measurements will be taken from two different angles at implant placement, implant loading, and final restoration.

  5. Implant Stability as Measured by ISQ at Final Restoration

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

    Implant stability was measured by ISQ and probe held facial-lingual and held mesial-lingual.

    An Osstell device is an instrument that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration. The result is presented as an Implant Stability Quotient (ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional information about the Osstell device can be found at www.osstell.com. Instructions on taking the measurements for this protocol will be provided in the Operation Manual. Two measurements will be taken from two different angles at implant placement, implant loading, and final restoration.

  6. Change in Soft Tissue Measurements

    Time frame: Soft tissue measurements were taken and compared between the test and the control group at final restoration (10 weeks post loading) and 12 months (± 1 month) post implant loading (implant loading=implant surgery + 10 weeks (+/-3 weeks)).

    The following table illustrates a comparison between Soft Tissue Mean Changes Around the Implant for delayed and immediate placements, measured at final restoration (10 weeks post loading) and the 12-month mark post implant loading. The parameters assessed included: CLTm (length of crown from highest point of soft tissue to incisal edge of the adjacent mesial tooth), CLTd (length of crown from highest point of soft tissue to incisal edge of the adjacent distal tooth), CLI (length of the implant crown from highest point of the soft tissue margin to the incisal edge), IPm (distance from the top of the papilla to the incisal edge mesial of the implant crown), IPd (distance from the top of the papilla to the incisal edge distal of the implant crown)

  7. Subject Satisfaction

    Time frame: 12 months post-loading

    Subject satisfaction related to pain, crown's esthetic, and crown's function was assessed at 12 months post-loading using Visual Analog Scales (VAS). Satisfaction range between 0 to 100 with Excruciating and Not satisfied at all at zero point and Nonexistent and Extremely satisfied at the 100 point. The table summarizes pain, satisfaction with function and satisfaction with esthetics at 12-months post loading.

  8. Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months

    Time frame: Measured at each study visit and throughout 12 months

    The frequency of adverse events and adverse device effects will be determined at 12 months post-loading and compared between the test and control arms. There were 38 total Adverse Events in 18 subjects out of 53 subjects. There were no SAEs related to procedure or device.

Sponsors and collaborators

Lead sponsor

Institut Straumann AG

Industry

Registry information

Official study title

Immediate Placement of the Straumann® Bone Level Tapered Implant With Early Loading in Single Tooth Gaps in the Maxilla and Mandible Compared to Delayed Placement

Important dates

Study start
2016
Primary completion
2019
Study completion
2025
First posted
Oct 7, 2015
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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