Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants
Study Details
Study Description
Brief Summary
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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.
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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 four-year follow-up.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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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.
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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 four-year follow-up.
-
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.
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: on1 abutment 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. |
Combination Product: use on1 abutment instead of healing cap in test group
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.
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| Active Comparator: healing cap After the operation, the embedded healing is selected. After waiting for three months, the second stage operation is needed to expose the healing cap |
Combination Product: use healing cap in control group
use healing cap in control group
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Outcome Measures
Primary Outcome Measures
- marginal bone level (MBL) [4 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Over 18 years old. 2. There were no contraindications to implant and tolerated ordinary implant surgery.
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Lack of teeth in the posterior area, sufficient bite space and no inclination of adjacent teeth are suitable for implantation, or appropriate adjustment can meet the indications of implantation operation.
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The bone mass at the missing tooth site is sufficient without additional surgery.
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Sign the informed consent form and give informed consent to the clinical study.
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Patients can adhere to follow-up. 7. Oral hygiene is basically normal, and all indicators basically meet the requirements. BOP < 20%, probe depth < 5mm.
Exclusion Criteria:
- 1.Uncontrolled systemic diseases such as uncontrolled severe diabetes, heart disease, hypertension, etc.
- General health cannot tolerate implant surgery 3. Implant surgery may adversely affect the patient's general condition 4. Patients take relevant drugs (bisphosphonates, etc.) that may affect bone union for a long time 5. Smoking patients, more than 10 cigarettes a day. 6.Untreated or uncontrollable periodontitis.
- There are tumors or other serious chronic diseases in the planting area. 8.Acute infection in the planting area. 9.Pregnant or lactating women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Affiliated Stomatology Hospital, Zhejiang University School of Medicine, 166 North Qiu'tao Road | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- The Dental Hospital of Zhejiang University School of Medicine
Investigators
- Study Chair: Hongye Lu, PhD, this hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DHZhejiangU - 2022(33)