Evaluating a new dental implant abutment for posterior teeth
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
NA · The Dental Hospital of Zhejiang University School of Medicine · NCT05399589
This study is testing a new dental implant piece for back teeth to see if it works better than the usual healing caps for patients getting implants.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Dental Hospital of Zhejiang University School of Medicine (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05399589 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy of the Nobel Parallel CC implant combined with the on1 abutment compared to traditional healing caps in posterior teeth. It is a prospective clinical study that will follow participants for five years, with evaluations including panoramic imaging to measure marginal bone levels and clinical assessments of implant conditions and patient satisfaction. The study will involve 80 patients, with 40 receiving the new on1 abutment and 40 receiving a conventional healing cap. The goal is to determine the clinical outcomes and benefits of the new abutment design over time.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require a single dental implant in the posterior region without any medical contraindications.
Not a fit: Patients with uncontrolled systemic diseases, severe malocclusion, or those who smoke heavily may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and satisfaction for patients receiving dental implants.
How similar studies have performed: While there are few clinical studies on the on1 abutment, the approach of using a fixed abutment during surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- The Affiliated Stomatology Hospital, Zhejiang University School of Medicine, 166 North Qiu'tao Road — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Fuming He, PhD
- Email: hfm@zju.edu.cn
- Phone: 13516817697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mechanical Failure of Dental Implant Nos, Dental implants, One abutment one time, Submerged healing, Bone Remodeling, Definitive abutment