Study on OsseoSpeed™ TX Short Implants in a Chinese Population

NCT01346696 | Completed Results

• 1 other identifier: CHN-0005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.

Conditions

Partially Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Level Alteration

  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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss.

  Evaluated from implant installation to 12 months after implant loading

Secondary Outcomes (7)

• Marginal Bone Level Alteration After 36 Months

  Evaluated from implant loading to 36 months after implant loading.

• Implant Survival

  Evaluated from implant installation to 36 months after implant loading.

• Implant Stability

  Evaluated 36 months after implant loading.

• Condition of the Periimplant Mucosa (PPD).

  Evaluated from implant loading to 36 months after implant loading.

• Condition of the Periimplant Mucosa (BoP).

  Evaluated from implant loading to 36 months after implant loading.

Study Arms (1)

OsseoSpeed™ TX implants

EXPERIMENTAL

OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.

Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)

Interventions

OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm) DEVICE

OsseoSpeed™ TX implants

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent
• Female and male aged 20-75 years at enrolment
• In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
• History of edentulism in the study area of at least four months
• Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
• Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
• Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm
• 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
• Earlier graft procedures in the study area
• 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
• Uncontrolled diabetes mellitus
• Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
• Smoking more than 10 cigarettes/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 enrolment in the present study
• Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
• Subjects that are unable to give informed consent

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (3)

Department of Periodontology, School of Stomatology, Peking University

Beijing, 100081, China

Location

Department of Implantology, School of Stomatology, Peking University

Beijing, China

Location

Second Dental and Periodontal Center, School of Stomatology, Peking University

Beijing, China

Location

Related Publications (2)

• Han J, Zhang X, Tang Z, Zhang L, Shi D, Meng H. A prospective, multicenter study assessing the DENTSPLY Implants, OsseoSpeed() TX, length 6 mm in the posterior maxilla and mandible: a 1-year follow-up study. Clin Oral Implants Res. 2016 Apr;27(4):452-7. doi: 10.1111/clr.12587. Epub 2015 Apr 9.

  PMID: 25855871 RESULT

• Han J, Tang Z, Zhang X, Meng H. A prospective, multi-center study assessing early loading with short implants in posterior regions. A 3-year post-loading follow-up study. Clin Implant Dent Relat Res. 2018 Feb;20(1):34-42. doi: 10.1111/cid.12568. Epub 2017 Dec 8.

  PMID: 29218810 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

• Huan Xin Meng, Prof

  Department of Periodontology, School of Stomatology, Beijing 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: May 2, 2011
• First Posted: May 3, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 8, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-10

Locations

CN (3)