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

Jaw, Edentulous, Partially Clinical Trial

Official title:

Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820235
• Other study ID #: YA-OSS-0003
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: September 2016

Study information

• Verified date: April 2020
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

The following should be considered at inclusion but can not be fulfilled until at Visit 2:

• 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

Exclusion Criteria:

• 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

• Unlikely to be able to comply with study procedures according to Investigators judgement

• Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study center)

• Previous enrollment or randomization of treatment in the present study.

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• OsseoSpeed™
OsseoSpeed™ implant
• NobelSpeedy™ Replace®
NobelSpeedy™ Replace® implant
• NanoTite™ Certain® PREVAIL®
NanoTite™ Certain® PREVAIL® implant

Locations

Country	Name	City	State
Canada	Faculty of Dentistry, McGill University	Montreal	Quebec
United States	University of North Carolina, School of Dentistry	Chapel Hill	North Carolina
United States	Perio Health Clinical Research Center	Houston	Texas
United States	University of Iowa, College of Dentistry	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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 — View Citation

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. — View Citation

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 fol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Marginal Bone Level Alterations	Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5-year follow-up visit compared to values obtained at time of implant placement.	Evaluated at time of implant installation and at the 5-year follow-up visit.
Secondary	Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	Condition of the periimplant mucosa by assessment of probing pocket depth (PPD).; Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).; Negative value = increased pocket depth.	Measured at time of loading of permanent restoration and at the 5-year follow-up.
Secondary	Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.	Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit.	Measured at the implant loading and at the 5-year follow-up after loading.