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
Phase: NA
Conditions: Mechanical Failure of Dental Implant Nos
Sponsor: The Dental Hospital of Zhejiang University School of Medicine

Clinical Efficacy of Nobel Parallel CC 
Implants With on1 Abutment in 
Posterior Area Participants 
 
 
 
 
NCT number: NCT05399589 
Document date: September 27, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study protocol 
1. Study design and population 
This study was approved by the ethics committee of the affiliated stomatology 
hospital of Zhejiang University medical college (No.2022-033), and then registered at 
clinicaltrials.gov under registration number (NCT05399589). The study was conducted 
according to the principles of Helsinki Declaration, following CONSORT guidelines 
for clinical trials. 
Patients treated with Nobel Parallel CC  implant in the posterior area without any 
bone augmentation in Zhejiang University Affiliated Stomatology Hospital during 
September 2021 and March 2022 were assigned into two groups by the primary stability: 
the two-piece abutment workflow (TAW) with a torque value of ≥35 Ncm, and the 
sealing screw with submerged healing workflow (SHW) with a torque value of <35 
Ncm. The number of Hounsfield units (HU) was measured in preoperative CBCT scans 
in order to exclude the significant differences of bone mineral density (BMD) in two 
groups referring to previous study28. All patients received treatment from an 
experienced clinician (F.H.). Patients were informed and provided their signed consent 
and permission. 
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. 
 
2 Sample size 
The sample size was determined by referencing to previous study’s data on MBL 
changes (mean and SD of two groups: 0.14mm ± 0.27mm and 0.64mm ± 0.64mm) 17, 
using G*Power 3.1 software with α=0.05 and 80% of power, which concluded that each 
group required 17 sample sizes. Ten percent additional patients were enrolled to 
compensate for possible dropouts. 
 
3 Surgery procedure 
After sterilization and local anesthesia, a full thickness flap was performed to fully 
expose the area. Nobel Parallel CC  implants (4.3-5.0mm in diameter and 10-11.5mm 
in length) were placed within 0-2 mm below the alveolar crest according to the 
thickness of mucosa, 1.5mm away from adjacent teeth or implants, while maintaining 
a buccal bone thickness of at least 1.5mm. After implantation, the primary stability was 
assessed by a torque wrench in order to determine the grouping. In TAW group, a 
1.75mm height Nobel Biocare® On-one  base was chose to connect to the implant 
torqued to 35Ncm according to thickness of mucosa. Afterwards, an On-one  healing 
cap was placed over it, and suture was performed with non-submerged healing. In SHW 
group, a sealing screw was connected to the implant with manual tightening and 
submerged healing. 
 
4 Prosthesis procedure 
Prosthetic procedures began 3 months after implantation with radiograph confirming 

the osseointegration. In TAW group, the closed-tray silicone method with direct 
impression copings was used to record precise implant position and accurately replicate 
surrounding tissues shape. While in SHW group, an additional intervention (secondary 
operation) was necessary to replace the healing cap with the height of 5mm /7mm, and 
the impression should be made in two weeks for soft tissue healing. When the healing 
cap was removed, the connective tissue in TAW group maintained adhesion to the On-
one  base, while in SHW group it detached from adhesion. Then, the full zirconium 
crown (Wieland, Wielandent Dental Technology Co., Ltd, German) with definitive 
abutment (Esthetic abutment, Nobel, Nobel Biocare®, Sweden) were delivered and 
tightened to a torque of 35Ncm, according to the manufacturer's recommendations after 
an additional 2-3 weeks. Patients were recalled for clinical and radiograph assessment 
at 6 months and 12 months after implantation. The schematic diagrams of each step in 
two groups were shown. 
 
5 Outcome measures 
(1) Survival rate and complications: the implants/prosthesis that did not need to be 
replaced within a year were considered as achieving survival. Osseointegration failure, 
peri-implant mucositis, peri-implantitis, implant/screw/abutment fracture, and 
porcelain collapse of prosthesis were recorded. 
(2) Radiograph measurement: MBL measurement was conducted using panoramic 
radiograph (Panoramic dental X-ray machine, 85kV, 16mA). The images were saved 
and quantified using the CorelDraw 11.0 software referred to the previous study4. The 
implant length was used as calibration reference, and the calibration formula was as 
following: 





*
/
*2
MBL
C
D
A
B


 
(3) Clinical evaluation: probing depth (PD), bleeding on probing (BOP), modified 
plaque index(mPI), calculus index (CI), and gingival index (GI) were measured to 
assess the soft tissue and oral hygiene condition in T2 and T3. Briefly, plastic UNC 12 
periodontal probe was used to measure the PD at mesial, middle, and distal sites of both 

buccal and lingual surfaces. Bleeding status at each site was recorded after 30 seconds. 
mPI, CI, and GI were recorded based on the evaluation criteria.  
 (4) Patient satisfaction: patients were required to answer the Oral Health Impact 
Profile-14 (OHIP-14) at T0 and T2, which mainly includes 14 questions, with scores 
ranging from "0=never", "1=almost not", "2=occasionally", "3=often", to "4=always" 
meaning the frequency with each question within the past month29. Visual analogue 
scale (VAS) was used at prosthesis loading including the first 6 questions and T2 
including the last 6 questions. Patients were instructed to indicate their perception 
experience by marking X on a 100mm horizontal line for each question. Participants' 
scores were obtained by measuring the distance between 0 and X (in millimeters, 
corresponding to 0-100 points, 0=completely unsatisfied, 100=fully satisfied30). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Statistical Analysis Plan 
The statistical analysis was performed using SPSS 26.0 software. A Shapiro-Wilk 
test was performed to assess the normality of the data. The Friedman test was employed 
to identify differences in MBL between TAW group and SHW group at: T0, T1, T2, 
and T3, and the Mann-Whitney U test was utilized to identify disparities in the change 
of MBL(ΔMBL) between the two groups at the following time intervals: T0-T1, T0-
T2, T0-T3, T1-T2, and T1-T3. Multivariate analyses in terms of these two workflows 
were conducted via generalized linear mixed model (GLMM) to adjust for potential 
confounding factors within inter-group differences. For soft tissue/oral hygiene 
indicators and patient satisfaction, Wilcoxon signed rank test or Mcnemar-Bowker test 
were used to evaluate the longitudinal alteration, and Mann-Whitney U test or Chi-
square test were used to analyze the differences between groups. The criteria for 
significance were set at p< 0.05. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Informed Consent Form 
 
Dear patient: 
We sincerely invite you to participate in a clinical study on the clinical efficacy of 
implants using Nobel Parallel CC On1 abutment in the upper and lower posterior tooth 
areas. This study was conducted by the Department of Prosthetics (Dr. He Fuming). It 
has been reviewed and approved by the Ethics Committee of the Affiliated 
Stomatological Hospital of Zhejiang University School of Medicine. 
Before deciding whether to participate in this study, please carefully read the following 
content. It can help you understand the study and why it was conducted, the procedure 
and duration of the study, and the potential benefits, risks, and inconveniences that 
participating in the study may bring to you. 
The following is a detailed introduction to this study: 
 
1. Research background 
For patients with long-term tooth loss, implant surgery has become one of the most 
common methods. The soft tissue barrier formed around the implant after implantation 
is crucial for establishing and maintaining healthy tissue around the implant. However, 
in ordinary bone tissue level implants, the repeated connection and disconnection 
between the abutment and the implant simultaneously affect the stability of early and 
long-term soft tissue healing. Numerous literature studies have shown that multiple 
connections and disconnections between the abutment and the implant are significantly 
correlated with increased bone loss at the edge of the implant. Nobel Parallel TM CC 
has proposed the new concept of On1, and the On1 platform has been launched in China 
and can be put into clinical use. This concept is based on a two-stage abutment, where 
the On1 abutment is directly placed on the implant during surgery and will not be 
disconnected thereafter. The healing abutment placed on the On1 abutment during 
surgery can be easily replaced with a permanent abutment. Equivalent to bone level 
implantation and soft tissue level repair, it can protect and preserve the bone interface 
and connective tissue during all repair processes, while reducing patient discomfort 

during treatment. At present, prospective clinical studies have found that the success 
rate, marginal bone resorption, and implant stability of Nobel Parallel TM CC implants 
combined with On1 abutment are good. However, there are relatively few clinical 
randomized controlled trials on Nobel Parallel TM CC implants combined with On1 
abutment and conventional healing abutment. 
 
2. Research objectives 
This study will investigate the application of Nobel Parallel in the upper and lower 
posterior tooth areas during a four-year follow-up period The clinical application effect 
of CC implant combined with On1 abutment, as the On1 abutment group (experimental 
group), and the simultaneous study of the application of Nobel Parallel in the upper and 
lower posterior tooth areasThe clinical application effect of CC implant combined with 
ordinary healing abutment as the control group. Study Nobel Parallel separately The 
therapeutic effect of using On1 abutment and ordinary healing abutment for CC 
implants in the maxillary posterior tooth area with sufficient bone mass without the 
need for bone grafting. Through long-term follow-up, periodontal indicators such as 
implant retention rate, restoration retention rate, implant edge bone level, keratinized 
gingival width, improved plaque index, improved gingival sulcus bleeding index, 
gingival index, peri implant probing depth, and patient satisfaction were measured in 
each group. Analyze Nobel Parallel The long-term clinical efficacy of CC implant 
system applied in the field of oral implantation. 
 
3. What do you need to do if you participate in the research 
1) Expected duration of participant participation in the trial 
After you sign the informed consent form, we will conduct subsequent research 
according to the established research protocol. The expected duration of your 
participation in the trial is 5 years, including a 1-year dental implant treatment stage 
and a 4-year dental implant follow-up stage. 
2) Grouping method and possibility of allocation to each group 
According to the established research protocol, successfully enrolled subjects will be 

randomly assigned to the experimental group (ono1 abutment) group and the control 
group (ordinary healing abutment) group using a random number table to generate a 
series of numbers, each corresponding to the patient's visit time. The grouping will be 
determined based on the parity of these numbers. 
The probability of you being assigned to each group is equal. 
3) Trial steps and obligations that subjects need to follow 
If you are assigned to the experimental group, we will treat you using the Nobel 
PCC+On1 abutment. 
If you are assigned to the control group, we will treat you using the Nobel 
PCC+conventional healing abutment. 
During the follow-up stage, you need to receive follow-up according to the agreed time 
between the doctor and you. The doctor may inquire about your situation through phone 
calls or in person visits. Your follow-up data will provide reliable data for the study and 
serve as a basis for doctors to determine the effectiveness of the treatment you have 
received. 
 
4. Possible benefits of participating in this study 
1) Experimental content involved in the study and its potential benefits and risks 
In this study, the implantation of Nobel Pcc on1 abutment was considered experimental. 
According to relevant research results, using ON1 abutment instead of conventional 
healing abutment in the upper part of Nobel Pcc implant restoration may have good 
clinical expected benefits. But we also remind you that any treatment may be ineffective, 
and there may be further development of the condition due to ineffective treatment or 
the combination of other diseases 
2) Possible benefits of participant participation in the study 
By participating in this study, you may gain a more comfortable oral treatment 
experience, understand your own oral health status, and acquire knowledge related to 
oral health protection. We will provide you with medical and health consultation. 
In addition, your participation may be beneficial for future understanding and scientific 
diagnosis of the etiology, development, impact, and other aspects of such diseases. The 

results of this study may be beneficial for providing more appropriate prevention, 
diagnosis, and treatment interventions for you and patients with similar diseases in the 
future. 
 
5. Confidentiality of your personal information 
Your medical records (including research medical records and physical and chemical 
examination reports, etc.) will be kept in the hospital according to regulations. 
Personnel unrelated to the study are not authorized to access your medical records 
without permission. Inspectors, auditors, ethics committees, and drug regulatory 
authorities may access your original medical records to verify the process and data of 
clinical trials, provided that confidentiality principles and relevant regulations are not 
violated. The public report of the results of this study will not disclose your personal 
identity. We will make every effort to protect the privacy of your personal medical data 
within the permitted scope. 
 
6. Termination of research participation 
Whether to participate in this study depends entirely on your voluntary choice. You may 
refuse to participate in this study, or withdraw from the trial at any time and stage during 
the research process without discrimination or retaliation, and your medical treatment 
and rights will not be affected. We will inform you promptly of any new information 
that may affect your ability to continue participating in the experiment. In addition, your 
participation in this study may be terminated due to the following reasons: 
1) You did not follow the instructions of the research doctor. 
2) You have encountered a serious situation that may require treatment. 
3) The research doctor believes that terminating the study is most beneficial for your 
health and well-being. 
 
I confirm that I have read and understood the informed consent form for this study, 
voluntarily accept the treatment methods in this study, and agree to use my medical data 
for publication in this study. 

Subject signature: 
Contact information: Date: 
Agent signature (if required): 
 Agent subject relationship: 
Contact information: Date: 
Witness signature (if required): 
Contact information: Date: 
I confirm that I have explained the detailed information of this study to the patient, 
including their rights, potential benefits, and risks, and provided them with a signed 
copy of the informed consent form. 
Subject signature: 
Contact information: Date: