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RecruitingNCT05399589Updated Apr 1, 2024

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

An interventional study of use on1 abutment instead of healing cap in test group and use healing cap in control group in Mechanical Failure of Dental Implant Nos, sponsored by The Dental Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by The Dental Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Sep 2021, registered May 2022).
  • Started Sep 2021; still recruiting 5 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mechanical Failure of Dental Implant Nos

Keywords

  • Dental implants
  • One abutment one time
  • Submerged healing
  • Bone Remodeling
  • Definitive abutment
03

In context

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine is the lead sponsor of 25 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Combination productuse 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.

  • Combination productuse healing cap in control group

    use healing cap in control group

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • The Affiliated Stomatology Hospital, Zhejiang University School of Medicine, 166 North Qiu'tao Road
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · Sep 27, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05399589
Lead sponsor
The Dental Hospital of Zhejiang University School of Medicine
Responsible party
Sponsor
First posted
Jun 1, 2022
Start date
Sep 27, 2021
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Apr 1, 2024

Study contacts

Fuming He, PhD
Contact
hfm@zju.edu.cn
13516817697
Jimin Jiang, Master
Contact
jjm328@zju.edu.cn
18867106859
Hongye Lu, PhD
study chair · this hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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