Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants (NCT05399589) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants
China48 participantsStarted 2021-09-27
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Adhere to follow-up.
Exclusion criteria
✕. 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;
What they're measuring
1
marginal bone level (MBL)
Timeframe: 5 years
Trial details
NCT IDNCT05399589
SponsorThe Dental Hospital of Zhejiang University School of Medicine