NCT05399589

Brief Summary

  1. 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. 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. 3.Study design and methods:

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Sep 2021Dec 2026

Study Start

First participant enrolled

September 27, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

4.8 years

First QC Date

May 2, 2022

Last Update Submit

March 28, 2024

Conditions

Mechanical Failure of Dental Implant Nos

Keywords

Dental implantsOne abutment one timeSubmerged healingBone RemodelingDefinitive abutment

Outcome Measures

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.

    5 years

Study Arms (2)

on1 abutment

EXPERIMENTAL

The on1 abutment was directly used in the operation to protect the soft tissue mucosa. After three months, the mold was taken directly for formal teeth.

Combination Product: use on1 abutment instead of healing cap in test group

healing cap

ACTIVE COMPARATOR

After the operation, the embedded healing is selected. After waiting for three months, the second stage operation is needed to expose the healing cap

Combination Product: use healing cap in control group

Interventions

use on1 abutment instead of healing cap in test groupCOMBINATION_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.

on1 abutment
use healing cap in control groupCOMBINATION_PRODUCT

use healing cap in control group

healing cap

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Implant site infection;
  • Pregnancy or lactation;
  • Severe malocclusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Stomatology Hospital, Zhejiang University School of Medicine, 166 North Qiu'tao Road

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hongye Lu, PhD

    this hospital

    STUDY CHAIR

Central Study Contacts

Fuming He, PhD

CONTACT

13516817697hfm@zju.edu.cn

Jimin Jiang, Master

CONTACT

18867106859jjm328@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

June 1, 2022

Study Start

September 27, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)