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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Dental Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

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

No requirement for further bone augmentation;

Sufficient space to place the abutment and future prosthesis;

Disqualifiers

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.);

Using drugs such as bisphosphonates within three months;

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

Uncontrolled periodontitis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • use healing cap in control group

    Combination product

    use healing cap in control group

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: on1 abutmentExperimental treatment 1 intervention
Group B: healing capActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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