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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| on1 abutment | Experimental | The on1 abutment was directly used in the operation to protect the soft tissue mucosa. After three months, the mold was taken directly for formal teeth. |
|
| healing cap | Active Comparator | After the operation, the embedded healing is selected. After waiting for three months, the second stage operation is needed to expose the healing cap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use on1 abutment instead of healing cap in test group | Combination Product | We will use on1 abutment instead of healing cap in a implant operation, since the former can protect the soft tissue barrier to a certain extent. |
| Measure | Description | Time Frame |
|---|---|---|
| marginal bone level (MBL) | The MBL of the mesial and distal sites of the implants will be measured using panoramic radiograph for the two groups of each period and converted. | 5 years |
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The inclusion criteria were as follows:
The exclusion criteria were as follows:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuming He, PhD | Contact | 13516817697 | hfm@zju.edu.cn | |
| Jimin Jiang, Master | Contact | 18867106859 | jjm328@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongye Lu, PhD | this hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Stomatology Hospital, Zhejiang University School of Medicine, 166 North Qiu'tao Road | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 27, 2021 |
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| use healing cap in control group | Combination Product | use healing cap in control group |
|
| Mar 28, 2024 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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