Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05399589
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2022-05-02
Brief Title:
Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants
Sponsor:
The Dental Hospital of Zhejiang University School of Medicine
Organization:
The Dental Hospital of Zhejiang University School of Medicine
Study Overview
Official Title:
Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants Participants Fuming He Jimin Jiang Hongye Lu To Evaluate the Long-term Efficacy of on1 Abutment Produced by Nobel Biocare Manufacturer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Research background NobelBiocare manufacture put forward a new abutment called on1 This concept is based on a two-stage abutment in which the on1 abutment is placed directly on the implant during surgery and will not be disconnected since then At present there are very a few clinical prospective studies about clinical effect of Nobelparallel CC implant combined with on1 abutment
2 Research objective This study will evaluate the clinical efficacy of Nobel parallel with on1 abutment compared to traditional healing cap in posterior teeth in a short termone year and long trem five year follow-up
3 Study design and methods
Design type prospective clinical study Study duration 5 years Start time From the date of adoption of ethics End time 2026 Follow up examination Panoramic images will be taken at all times to measure the marginal bone level of the implant Clinical examination and questionnaire survey will be conducted to obtain the implant conditions and patients satisfaction Periodontal indexes such as keratinized gingival width plaque index gingival index bleeding on probe probing depth of peri-implant tissue will be evaluate
2 Research objective This study will evaluate the clinical efficacy of Nobel parallel with on1 abutment compared to traditional healing cap in posterior teeth in a short termone year and long trem five year follow-up
3 Study design and methods
Design type prospective clinical study Study duration 5 years Start time From the date of adoption of ethics End time 2026 Follow up examination Panoramic images will be taken at all times to measure the marginal bone level of the implant Clinical examination and questionnaire survey will be conducted to obtain the implant conditions and patients satisfaction Periodontal indexes such as keratinized gingival width plaque index gingival index bleeding on probe probing depth of peri-implant tissue will be evaluate
Detailed Description:
1 Research background NobelBiocare manufacture put forward a new abutment called on1 This concept is based on a two-stage abutment in which the on1 abutment is placed directly on the implant during surgery and will not be disconnected since then At present there are very a few clinical prospective studies about clinical effect of Nobelparallel CC implant combined with on1 abutment
2 Research objective This study will evaluate the clinical efficacy of Nobel parallel with on1 abutment compared to traditional healing cap in posterior teeth during a five-year follow-up
3 Study design and methods
Design type prospective clinical study Non randomized clinical trial Study duration 5 years Start time From the date of adoption of ethics End time 2026 Follow up examination Panoramic images will be taken at all times to measure the marginal bone level of the implant Clinical examination and questionnaire survey will be conducted to obtain the implant conditions and patients satisfaction Periodontal indexes such as keratinized gingival width plaque index gingival index bleeding on probe probing depth of peri-implant tissue will be evaluate
Introduction to the research scheme Implants of Nobel Parallel CC will be implanted into the posterior teeth in the Affiliated Stomatology Hospital Zhejiang University School of Medicine since the date of ethical adoption Forty patients with on1 abutment will be placed with implant Forty patients with common healing abutment will be selected with the same implants simultaneously Panoramic images will be evaluated before surgery immediately after surgery immediately 3 months 1 year 2 years 3 years and 4 years after prosthesis loading Clinical examination and questionnaire survey will be carried out 4 years after prosthesis loading to obtain periodontal indexes about peri-implant tissues Through the evaluation of the above experimental data on1 abutment with implant will be analyzed about the clinical efficacy
2 Research objective This study will evaluate the clinical efficacy of Nobel parallel with on1 abutment compared to traditional healing cap in posterior teeth during a five-year follow-up
3 Study design and methods
Design type prospective clinical study Non randomized clinical trial Study duration 5 years Start time From the date of adoption of ethics End time 2026 Follow up examination Panoramic images will be taken at all times to measure the marginal bone level of the implant Clinical examination and questionnaire survey will be conducted to obtain the implant conditions and patients satisfaction Periodontal indexes such as keratinized gingival width plaque index gingival index bleeding on probe probing depth of peri-implant tissue will be evaluate
Introduction to the research scheme Implants of Nobel Parallel CC will be implanted into the posterior teeth in the Affiliated Stomatology Hospital Zhejiang University School of Medicine since the date of ethical adoption Forty patients with on1 abutment will be placed with implant Forty patients with common healing abutment will be selected with the same implants simultaneously Panoramic images will be evaluated before surgery immediately after surgery immediately 3 months 1 year 2 years 3 years and 4 years after prosthesis loading Clinical examination and questionnaire survey will be carried out 4 years after prosthesis loading to obtain periodontal indexes about peri-implant tissues Through the evaluation of the above experimental data on1 abutment with implant will be analyzed about the clinical efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None