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

NCT05399589 · tracked via the Priya Life Science China tracker

Sponsor

The Dental Hospital of Zhejiang University School of Medicine

Phase

Not applicable

Started

2021-09-27

Last updated

2024-04-01

Condition(s) studied

Mechanical Failure of Dental Implant Nos

Investigational drug(s) / intervention(s)

use on1 abutment instead of healing cap in test groupuse healing cap in control group

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.

use healing cap in control group: use healing cap in control group

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

marginal bone level (MBL) — 5 years
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.

Trial sites (1)

Facility	City	Region	Status
The Affiliated Stomatology Hospital, Zhejiang University School of Medicine, 166 North Qiu'tao Road	Hangzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05399589 on ClinicalTrials.gov ↗ ← All trials in China