Clinical trial NCT00820235: Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw
Official title: Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
timeFrame: Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading
Secondary outcomes:
measure: Marginal Bone Level Alterations
timeFrame: Evaluated at time of implant installation and at the 5-year follow-up visit.
measure: Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
timeFrame: Measured at time of loading of permanent restoration and at the 5-year follow-up.
measure: Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.
timeFrame: Measured at the implant loading and at the 5-year follow-up after loading.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa, College of Dentistry
state: Iowa
city: Chapel Hill
country: United States
facility: University of North Carolina, School of Dentistry
state: North Carolina
city: Houston
country: United States
facility: Perio Health Clinical Research Center
state: Texas
city: Montreal
country: Canada
facility: Faculty of Dentistry, McGill University
state: Quebec
Study officials:
affiliation: University of Illinois College of Dentistry
name: Lyndon Cooper, Prof.
role: STUDY_DIRECTOR
References:
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 follow-up. Int J Periodontics Restorative Dent. 2015 Mar-Apr;35(2):149-59. doi: 10.11607/prd.2341.
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. 2015 May-Jun;30(3):622-32. doi: 10.11607/jomi.3772.
citation: 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.