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Dental implant system (including dental drill) is used for clinical research on the target value of prospective, multi-center and single group of dental restoration after tooth loss.

Dental implant system (including dental drill) is used for clinical research on the target value of prospective, multi-center and single group of dental restoration after tooth loss.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-17012736
Enrollment
Unknown
Registered
2017-09-19
Start date
2017-10-09
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dental implants

Interventions

Sponsors

Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The subject voluntarily participates in the trial and signs on Informed Consent Form; 2. The patient of which the age is 18 to 75 years old; 3. The patient who suffers from dentition damage or loss and needs dental implant therapy; 4. The edentulousalveolar cavity healed well, or more than three months passed after tooth extraction; 5. Theedentulous area has sufficient bone height and width for implant placement; 6. The implant area has healthy attached gingiva with sufficient thickness and width; 7. The oral mucosa or soft tissue has no significant inflammation or lesion; 8. The patient can communicate well with the researcher and can follow the entire verification requirements.

Exclusion criteria

Exclusion criteria: 1. Malocclusion or bad mastication habit affected the edentulousperiphery, which may lead to an implantation failure caused by the injury of bone tissue around the implant; the partial alveolar bone has any pathologic change; the oral mucosa has any lesion; the edentulous area has severe soft tissue lesion or severe periodontal disease; mouth opening is restricted; the bone mass and density in the edentulous area are unsatisfactory and difficult to improve; 2. The patient suffers acute infection or serious infection; 3. The patient is a pregnant woman or a breast-feeding woman; 4. The patient has long-term administration of special medicines such as hormones, anticoagulant drugs, etc.; 5. The patient has a poor condition of body health or nutrition; 6. The patient who suffers hematological disease and cardiovascular disease that are not controlled (coronary heart disease, congenital heart disease, etc.); 7. Systemic or localized bone disease is considered the contradiction of implant rehabilitation, such as bone tuberculosis, osteitis, bone tumor, etc.; 8. The patient who suffers systemic immune disease; 9. The patient who suffers nervous system disease, such as epileptic; 10. The patient who suffers mental disease or psychological barrier; 11. The patient who suffers endocrinal and metabolic disease that is not controlled; 12. The patient who has a history of head and neck radiotherapy or received chemotherapy within recent five years; 13. The patient who is allergic to metals; 14. Other cases in which the patient is unsuitable to participate in the research in the opinion of researcher.

Design outcomes

Primary

MeasureTime frame
Implant success rate;

Secondary

MeasureTime frame
the side effect that may occur after the patient is implanted with this dental implant system, to record in each visit the damage and looseness of the implant and its abutment, bone loss around the implant, fracture or infection of the implant, etc.;;

Countries

China

Contacts

Public ContactYuanliang Huang

Shanghai East Hospital

ylhuang0115@163.com+86 13301921076

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026