Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants

NCT ID: NCT05399589

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2026-12-30

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 term(one 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.

Conditions

Mechanical Failure of Dental Implant Nos

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

use on1 abutment instead of healing cap in test group

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

use healing cap in control group

Intervention Type: COMBINATION_PRODUCT

use healing cap in control group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

use healing cap in control group

use healing cap in control group

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. At least eighteen years old without any medical contraindications, able to tolerate dental implant surgery;

2. Planned to implant with Nobel Parallel CC™ in the maxillary or mandible posterior tooth regions with single-implant-prosthesis design;

3. No requirement for further bone augmentation;

4. Sufficient space to place the abutment and future prosthesis;

5. Adhere to follow-up.

Exclusion Criteria

1. Uncontrolled systematic diseases (blood pressure >180/100 mmHg, fasting blood glucose >8.88 mmol/L, myocardial infarction in six months, cardiac function class III to IV, third- or second-degree II atrioventricular block, and double bundle branch block et al.);

2. Using drugs such as bisphosphonates within three months;

3. Heavy smoker (≥ 10 cigarettes per day), alcoholism, and drug abuse;

4. Uncontrolled periodontitis;

5. Implant site infection;

6. Pregnancy or lactation;

7. Severe malocclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Dental Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongye Lu, PhD

Role: STUDY_CHAIR

this hospital

Locations

The Affiliated Stomatology Hospital, Zhejiang University School of Medicine, 166 North Qiu'tao Road

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fuming He, PhD

Role: CONTACT

hfm@zju.edu.cn

13516817697

Jimin Jiang, Master

Role: CONTACT

jjm328@zju.edu.cn

18867106859

Facility Contacts

Fuming He, PhD

Role: primary

hfm@zju.edu.cn

13516817697

Jimin Jiang, Master

Role: backup

jjm328@zju.edu.cn

18867106859

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

DHZhejiangU - 2022(33)

Identifier Type: -

Identifier Source: org_study_id