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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Failure of Dental Implant Nos
• Intervention / Treatment: Combination product: use on1 abutment instead of healing cap in test group; Combination product: use healing cap in control group

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fuming He, PhD; Phone Number: 13516817697; Email: hfm@zju.edu.cn
• Study Contact Backup: Name: Jimin Jiang, Master; Phone Number: 18867106859; Email: jjm328@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Affiliated Stomatology Hospital, Zhejiang University School of Medicine, 166 North Qiu'tao Road
      • Contact: Fuming He, PhD; Phone Number: 13516817697; Email: hfm@zju.edu.cn
      • Contact: Jimin Jiang, Master; Phone Number: 18867106859; Email: jjm328@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

The inclusion criteria were as follows:

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.

The exclusion criteria were as follows:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine
• Investigators: Study Chair: Hongye Lu, PhD, this hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Dental implants; Bone Remodeling; One abutment one time; Definitive abutment; Submerged healing
• Other Study ID Numbers: DHZhejiangU - 2022(33)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No