Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface

Immediate and Delayed Loading of 4.1 mm and 4.8 mm Implants in the Posterior Mandible & Maxilla: A Controlled Randomized Study of Single or 2-4 Unit Restorations Loaded Immediately After Surgery or Four Weeks After Surgery

The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism
• Intervention / Treatment: Device: SLActive dental implant

Detailed Description

This study is a post-market randomized study whereby each patient will receive 1 to 4 implants placed in the posterior maxilla or mandible. The primary objective of this randomized open study is to evaluate the performance in immediate and delayed loading (4 weeks) of Straumann standard solid screw 4.1mm and the 4.8 mm diameter wide neck implants with a new surface. These implants will support single crowns or 2 to 4 unit bridge restorations in the posterior maxilla or mandible and the treatment will be evaluated for the immediate and delayed loading procedures at one year post surgery. Patients will be allocated into two groups and then randomized into immediate or delayed loading arms.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Tiroler Landeskrankenanstaltengesellschaft mbH
• Germany
  • Bochum, Germany
    • Praxisklinik fur Mund- Keifer- und Gesichtschirurgie
  • Furth, Germany
    • Private practice
  • Hamburg, Germany
    • Klinikum Nord-Heidberg
  • Weiden, Germany
    • Private practice
  • Witten, Germany
    • Private Universitat Witten
• Ireland
  • Belfast, Ireland
    • Queens University
  • Dublin, Ireland
    • Dublin Dental Hospital
• Netherlands
  • Leiderdorp, Netherlands
    • Rijnland Hospital
• Portugal
  • Coimbra, Portugal
    • Faculdade de medicina de coimbra
  • Oporto, Portugal
    • Private practice
• Spain
  • Barcelona, Spain
    • Private practice
  • Malaga, Spain
    • Private practice
  • Palma de Mallorca, Spain
    • Clinica Periobalear
• Sweden
  • Falun, Sweden
    • Private practice
• Switzerland
  • St. Gallen, Switzerland
    • Private practice
• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Private practice
  • Indiana
    • Indianapolis, Indiana, United States, 46280
      • Private practice
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females must be at least 18 years of age
• Have at least one missing tooth in positions FDI 4, 5, 6, or 7 in any quadrant (ADA positions 2, 3, 4, 5; or 12, 13, 14, 15; or 20, 21, 22, 23; or 28, 29, 30, 31.)
• Subjects desire an implant supported restoration on1 to 4 implants per quadrant
• The tooth/teeth position(s) at the proposed implant site must have been extracted or lost at least 4 months before the date of implantation and be fully healed
• Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann standard 4.1 mm diameter implant of at least 8 mm length without the use of concurrent bone augmentation techniques. If more bone is available and is indicated a Straumann standard 4.8 mm diameter implant with a wide neck of at least 8 mm length may be used, i.e. implant insertion sites must have sufficient bone height such that the implant will not encroach on vital structures and sufficient width that a minimum of 1 mm of bone lingual and buccal bone will remain
• The opposing dentition must be natural teeth or fixed crowns or bridges on natural teeth or implants. Removable prostheses or dentures opposing the study implants are not allowed
• Patients must be committed to the study for its full duration.

Exclusion Criteria:

• Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
• Medical conditions requiring prolonged use of steroids
• History of leukocyte dysfunction and deficiencies
• History of bleeding disorders
• History of neoplastic disease requiring the use of chemotherapy
• History of radiation therapy to the head and neck
• Patients with history of renal failure
• Patients with severe or uncontrolled metabolic bone disorders
• Uncontrolled endocrine disorders
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene
• Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0
• Alcoholism or drug abuse
• Patients infected with HIV
• Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew tobacco
• 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
• Local inflammation, including untreated periodontitis
• Mucosal diseases such as erosive lichen planus
• History of local irradiation therapy
• Presence of osseous lesions
• Unhealed extraction sites (less than 4 months post extraction of teeth in intended sites)
• Bone surgery (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement and the site fully healed. Note: Minor bone enhancement using harvested bone from the implant site and a resorbable membrane is allowed at the time of implant placement
• Patients requiring bone grafting at the surgical sites at the time of surgery.
• Severe bruxing or clenching habits
• Persistent intraoral infection
• Lack of primary stability of one (or more) implant(s) at surgery. In this instance the patient must be withdrawn and the patient treated accordingly
• Patients with inadequate oral hygiene or unmotivated for adequate home care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate Loading; SLActive dental implant(s) will be restored with a temporary restoration on the day of surgery.	Device: SLActive dental implant; Straumann® SLActive implants will be placed. Implants in Arm 1 will be restored with a temporary restoration on the day of surgery. Implants in Arm 2 will receive healing caps immediately after surgery and a provisional restoration will be placed between day 28 to day 34 post-surgery. In both arms, the final restoration will be placed between 140 and 160 days (20 to 23 weeks) post-surgery.; Other Names: SLActive
Active Comparator: Early Loading; Healing caps will be placed on the SLActive dental implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery	Device: SLActive dental implant; Straumann® SLActive implants will be placed. Implants in Arm 1 will be restored with a temporary restoration on the day of surgery. Implants in Arm 2 will receive healing caps immediately after surgery and a provisional restoration will be placed between day 28 to day 34 post-surgery. In both arms, the final restoration will be placed between 140 and 160 days (20 to 23 weeks) post-surgery.; Other Names: SLActive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.	Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.	Change in crestal bone level from surgery (baseline) to 1 year post-surgery
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.	Change in crestal bone level from surgery (baseline) to 2 years post-surgery
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.	Change in crestal bone level from surgery (baseline) to 3 years post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival	Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation	20-23 Weeks post-surgery
Implant Survival	Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation	1 year post-surgery
Implant Survival	Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation	2 years post-surgery
Implant Survival	Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation	3 years post-surgery
Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected	Patients affected by AE Patients affected by related/ unknown AE	until the 3 year post-surgery
Implant Success	Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant	20-23 weeks post-surgery
Implant Success	Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant	1 years post-surgery
Implant Success	Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant	2 years post-surgery
Implant Success	Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant	3 years post-surgery
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events	Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)	until the 3 year post-surgery

Collaborators and Investigators

• Sponsor: Institut Straumann AG
• Investigators: Principal Investigator: Axel Zöllner, DDS, Private Universität Witten/ Herdecke

Publications and helpful links

General Publications

• Zollner A, Ganeles J, Korostoff J, Guerra F, Krafft T, Bragger U. Immediate and early non-occlusal loading of Straumann implants with a chemically modified surface (SLActive) in the posterior mandible and maxilla: interim results from a prospective multicenter randomized-controlled study. Clin Oral Implants Res. 2008 May;19(5):442-50. doi: 10.1111/j.1600-0501.2007.01517.x.
• Ganeles J, Zollner A, Jackowski J, ten Bruggenkate C, Beagle J, Guerra F. Immediate and early loading of Straumann implants with a chemically modified surface (SLActive) in the posterior mandible and maxilla: 1-year results from a prospective multicenter study. Clin Oral Implants Res. 2008 Nov;19(11):1119-28. doi: 10.1111/j.1600-0501.2008.01626.x.
• Nicolau P, Korostoff J, Ganeles J, Jackowski J, Krafft T, Neves M, Divi J, Rasse M, Guerra F, Fischer K. Immediate and early loading of chemically modified implants in posterior jaws: 3-year results from a prospective randomized multicenter study. Clin Implant Dent Relat Res. 2013 Aug;15(4):600-12. doi: 10.1111/j.1708-8208.2011.00418.x. Epub 2011 Dec 15.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 31, 2008

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Dental implants
• Other Study ID Numbers: CR 06/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No