NCT01473355

Brief Summary

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

October 7, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

2.9 years

First QC Date

November 15, 2011

Results QC Date

February 11, 2019

Last Update Submit

October 7, 2019

Conditions

Partially Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

  • Number of Survived Implants

    Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function

    Measured at the 3 year follow-up after implant loading.

Secondary Outcomes (5)

  • Marginal Bone Level Alteration

    Measured at the 3 year follow-up after implant loading.

  • Number of Stable Implants

    Measured at the 3 year follow-up after implant loading.

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

    Measured at the 3 year follow-up after implant loading.

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

    Measured at the 3 year follow-up after implant loading.

  • Presence of Plaque

    Measured at the 3 year follow-up after implant loading.

Study Arms (1)

OsseoSpeed™ TX

EXPERIMENTAL

OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm

Device: OsseoSpeed™ TX

Interventions

OsseoSpeed™ TXDEVICE

OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

OsseoSpeed™ TX

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent
  • Aged 20-75 years at enrolment
  • History of edentulism in the study area of at least two months
  • Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
  • Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
  • Deemed by the investigator as likely to present an initially stable implant situation

You may not qualify if:

  • Unlikely to be able to comply with study procedures, as judged by the investigator
  • Uncontrolled pathologic processes in the oral cavity
  • Known or suspected current malignancy
  • History of radiation therapy in the head and neck region
  • History of chemotherapy within 5 years prior to surgery
  • Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
  • Uncontrolled diabetes mellitus
  • Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
  • Smoking more than 10 cigarettes per day
  • Present alcohol and/or drug abuse
  • Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
  • Previous enrollment in the present study
  • Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

School of Stomatology, JiLin University, Hospital of Stomatology

Changchun, China

Location

Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, 310003, China

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Results Point of Contact

Title
Manager Global Clinical Research
Organization
Dentsply Sirona Implants, Mölndal, SWEDEN
ClinicalResearchMolndal@dentsplysirona.com
0046313763500

Study Officials

  • Ping Gong, Prof

    Sichuan University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 17, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2014

Study Completion

October 1, 2016

Last Updated

October 15, 2019

Results First Posted

October 7, 2019

Record last verified: 2019-10

Locations

CN(3)