Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw

NCT00820235 | Completed Results

• 1 other identifier: YA-OSS-0003
• Study Type: interventional
• Target: 141
• Locations: 2 countries
• Sites: 4

Brief Summary

The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.

Conditions

Jaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (1)

• Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.

  Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading. The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.

  Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading

Secondary Outcomes (3)

• Marginal Bone Level Alterations

  Evaluated at time of implant installation and at the 5-year follow-up visit.

• Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD

  Measured at time of loading of permanent restoration and at the 5-year follow-up.

• Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.

  Measured at the implant loading and at the 5-year follow-up after loading.

Study Arms (3)

A

EXPERIMENTAL

Device: OsseoSpeed™

B

ACTIVE COMPARATOR

Device: NobelSpeedy™ Replace®

C

ACTIVE COMPARATOR

Device: NanoTite™ Certain® PREVAIL®

Interventions

OsseoSpeed™ DEVICE

OsseoSpeed™ implant

A

NobelSpeedy™ Replace® DEVICE

NobelSpeedy™ Replace® implant

B

NanoTite™ Certain® PREVAIL® DEVICE

NanoTite™ Certain® PREVAIL® implant

C

Eligibility Criteria

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

You may qualify if:

• Provision of informed consent
• At least 18 years
• In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24
• Edentulous for at least 5 months at study site
• A buccal-lingual bone width at study site of at least 5.5 mm
• A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm
• A keratinized mid-buccal mucosal height of at least 2 mm at study site
• Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (\>1 mm) and/or significant soft tissue loss
• Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions
• An opposing dentition with teeth, implants or prosthesis

You may not qualify if:

• Insufficient interocclusal distance for implant placement and restoration at study site
• Tooth adjacent (mesial and/or distal) to study site is ankylosed
• More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
• Site development (bone tissue) performed at less than 5 months before Visit 2 at study site
• Untreated rampant caries and/or uncontrolled periodontal disease
• Class II division 2 malocclusion (Edward Hartley Angle)
• Use of tobacco within last 6 months
• Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus)
• Current alcohol or drug abuse
• Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
• Use of any substance that will influence bone metabolism
• Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
• History of radiation in the head and neck region
• Known pregnancy, pregnancy tests will be performed as per local requirements.
• Unable or unwilling to return for follow-up visits for a period of 5 years

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (4)

University of Iowa, College of Dentistry

Iowa City, Iowa, 52242-1010, United States

Location

University of North Carolina, School of Dentistry

Chapel Hill, North Carolina, 27599-7450, United States

Location

Perio Health Clinical Research Center

Houston, Texas, 77063, United States

Location

Faculty of Dentistry, McGill University

Montreal, Quebec, H3A 2K6, Canada

Location

Related Publications (3)

• McGuire MK, Scheyer T, Ho DK, Stanford CM, Feine JS, Cooper LF. Esthetic outcomes in relation to implant-abutment interface design following a standardized treatment protocol in a multicenter randomized controlled trial--a cohort of 12 cases at 1-year follow-up. Int J Periodontics Restorative Dent. 2015 Mar-Apr;35(2):149-59. doi: 10.11607/prd.2341.

  PMID: 25738335 RESULT

• Cooper LF, Reside G, Stanford C, Barwacz C, Feine J, Abi Nader S, Scheyer ET, McGuire M. A multicenter randomized comparative trial of implants with different abutment interfaces to replace anterior maxillary single teeth. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):622-32. doi: 10.11607/jomi.3772.

  PMID: 26009913 RESULT

• Barwacz CA, Stanford CM, Diehl UA, Qian F, Cooper LF, Feine J, McGuire M. Electronic assessment of peri-implant mucosal esthetics around three implant-abutment configurations: a randomized clinical trial. Clin Oral Implants Res. 2016 Jun;27(6):707-15. doi: 10.1111/clr.12640. Epub 2015 Jun 21.

  PMID: 26096162 RESULT

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: Manager Global Clinical Research
• Organization: Dentsply Sirona Implants, Mölndal, SWEDEN

ClinicalResearchMolndal@dentsplysirona.com

0046313763500

Study Officials

• Lyndon Cooper, Prof.

  University of Illinois College of Dentistry

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: January 9, 2009
• First Posted: January 12, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 7, 2020
• Results First Posted: May 7, 2020

Record last verified: 2020-04

Locations

CA (1); US (3)