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

Phase 4

Completed

Conditions: Partial Edentulism

Interventions: Device: SLActive dental implant

Registration Number: NCT00782171

Lead Sponsor: Institut Straumann AG

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 266

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Loading	SLActive dental implant	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
Immediate Loading	SLActive dental implant	SLActive dental implant(s) will be restored with a temporary restoration on the day of surgery.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Implant Survival	3 years post-surgery	Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events	until the 3 year post-surgery	Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)
Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected	until the 3 year post-surgery	Patients affected by AE Patients affected by related/ unknown AE
Implant Success	3 years post-surgery	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

Trial Locations

Locations (11): University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Praxisklinik fur Mund- Keifer- und Gesichtschirurgie
🇩🇪
Bochum, Germany
Private Universitat Witten
🇩🇪
Witten, Germany
Klinikum Nord-Heidberg
🇩🇪
Hamburg, Germany
Dublin Dental Hospital
🇮🇪
Dublin, Ireland
Rijnland Hospital
🇳🇱
Leiderdorp, Netherlands
Clinica Periobalear
🇪🇸
Palma de Mallorca, Spain
Private Practice
🇨🇭
St. Gallen, Switzerland
Tiroler Landeskrankenanstaltengesellschaft mbH
🇦🇹
Innsbruck, Austria
Queens University
🇮🇪
Belfast, Ireland
Faculdade de medicina de coimbra
🇵🇹
Coimbra, Portugal