Clinical Comparison of On1 Two-stage Abutment With One-stage Abutment on Different Implant Neck Design

NCT06022042 | Active Not Recruiting

• 1 other identifier: DHZhejiangU-2022(027)
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

In clinical implant treatment, the healing abutment or temporary abutment needs to be removed or replaced multiple times after implant insertion and before prosthesis restoration. During this process, the friction between connective tissue around the implant cannot be avoided. Different from natural periodontal tissue, soft tissue around the implant lacks the periodontal ligament barrier and periodontal ligament blood supply, and is more likely to be damaged during repeated wearing. The integrity, health and stability of the peri-implant connective tissue is crucial to the implant osseointegratio. Through randomized controlled trials and meta-analysis, Marco Tallarico et al found that repeated removal of one-stage abutments can significantly increase bone resorption. Based on this situation, the design of implant neck and abutment, especially the design concept of smooth collar, has attracted widespread attention. The design of smooth collars with different heights can isolate the mechanical damage of the abutment to the connective tissue around the implant to different degrees. Among them, the On1 two-stage abutment has a smooth collar with a height of 1.75-2.5mm, and the Nobel implants have a smooth neck design ranging from 0-0.75mm to protect the connective tissue around the implant. Through a systematic review and meta-analysis, Qing-qing Wang et al concludes that direct mechanical stimulation from the abutment has long-term adverse effects on peri-implant connective tissue and bone tissue. However, whether the On1 two-stage abutment has a positive effect on the stabilization of the peri-implant soft tissue and bone tissue remains to be studied. At the same time, the relative height of the smooth collar increased by the On1 abutment in the implants with different neck designs varies to some extent, and further research is still needed to provide evidence about the effect of the On1 abutment on the tissue surrounding the implants with different neck designs. In conclusion, this study took On1 two-stage abutment and traditional one-stage abutment as the research objects to compare and evaluate the clinical effects of the two in different implant neck design.

Conditions

Implant Site Reaction

Outcome Measures

Primary Outcomes (2)

• The degree of bone resorption at the shoulder edge of the implant

  1. Thickness of the buccal bone plate 0 mm below the implant abutment (W1): Select the mid-axis of the implant in the sagittal plane.The thickness of the lateral buccal plate (W1) is determined by selecting the mid-axis of the implant in the sagittal plane and making a straight line perpendicular to the long axis of the implant to the buccal side of the implant table. 2. Thickness of the buccal bone plate 2、4、6 mm below the implant abutment (W2、W3、W4): select the sagittal implant centre axis and make a straight line perpendicular to the long axis of the implant, starting from the buccal bone plate.(W2、W3、W4): Choose the mid-axis of the implant in the sagittal plane and start from the buccal bone plate and make a straight line perpendicular to the long axis of the implant to the distance from the buccal side of the implant 2、4、6 mm below the shoulder table.

  1-7 years

• The distance between the level of implant shoulder and the alveolar ridge.

  The distance between the level of implant shoulder and the alveolar ridge.

  1-7 years

Secondary Outcomes (6)

• buccal bone wall thickness at 0/2/4/6 mm below the implant shoulder

  1-7 years

• mesial and distal gingival papilla and buccal mucosa recession

  1-7 years

• abutment buccal keratinized gingiva width

  1-7 years

• probing bleeding index

  1-7 years

• Patients' self-satisfaction visual analogue scale score

  within 30 minutes

Study Arms (6)

On1 Abutment + Nobel PMC implant Set

EXPERIMENTAL

Subjects who takes implant therapy using On1 Abutment + Nobel PMC implant

Device: On1 two-stage abutment and one-stage abutment

On1 Abutment + Nobel PCC Implant Set

EXPERIMENTAL

Subjects who takes implant therapy using On1 Abutment + Nobel PCC Implant

Device: On1 two-stage abutment and one-stage abutment

On1 Abutment + Nobel CC Implant Set

EXPERIMENTAL

Subjects who takes implant therapy using On1 Abutment + Nobel CC Implant

Device: On1 two-stage abutment and one-stage abutment

One-Stage Abutment + Nobel PMC Implant Set

ACTIVE COMPARATOR

Subjects who takes implant therapy using One-Stage Abutment + Nobel PMC Implant

Device: On1 two-stage abutment and one-stage abutment

One-Stage Abutment + Nobel PCC Implant Set

ACTIVE COMPARATOR

Subjects who takes implant therapy using One-Stage Abutment + Nobel PCC Implant

Device: On1 two-stage abutment and one-stage abutment

One-Stage Abutment + Nobel CC Implant Set

ACTIVE COMPARATOR

Subjects who takes implant therapy using One-Stage Abutment + Nobel CC Implant

Device: On1 two-stage abutment and one-stage abutment

Interventions

On1 two-stage abutment and one-stage abutment DEVICE

the On1 two-stage abutment has a smooth collar with a height of 1.75-2.5mm, and the Nobel implants have a smooth neck design ranging from 0-0.75mm to protect the connective tissue around the implant.

Also known as: Nobel PMC implant, Nobel CC implant, Nobel PCC implant

On1 Abutment + Nobel CC Implant Set; On1 Abutment + Nobel PCC Implant Set; On1 Abutment + Nobel PMC implant Set; One-Stage Abutment + Nobel CC Implant Set; One-Stage Abutment + Nobel PCC Implant Set; One-Stage Abutment + Nobel PMC Implant Set

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) aged 18 years and above, 70 years old and below; (2) Single crown restoration after implantation (3) Subjects signed written informed consent; (4) The general health status is good and adhered to Good oral hygiene conditions; (5) no infection and extraction residues at the implant site; (6) sufficient keratinized gingiva on the cheek and tongue; (7) good and stable occlusal relationship; (8) the occlusal gap is higher than 4mm; (9) No other additional operations are planned to perform.

You may not qualify if:

• (1) contraindications to general implant surgery; (2) uncontrolled diabetes mellitus; (3) any signs of immunosuppression; (4) previous head and neck radiation therapy; (5) past or current use of bisphosphonates treatment; (6) substance abuse; (7) nocturnal teeth grinding; (8) signs of periodontitis; (9) smoking more than 10 cigarettes per day; (10) poor oral hygiene; (11) mental disorders; (12) inability to complete follow-up; (13) History of night grinding.

Sponsors & Collaborators

• Yi Zhou: lead

Study Sites (1)

The Stomatologic Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (2)

• Tallarico M, Caneva M, Meloni SM, Xhanari E, Covani U, Canullo L. Definitive Abutments Placed at Implant Insertion and Never Removed: Is It an Effective Approach? A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Oral Maxillofac Surg. 2018 Feb;76(2):316-324. doi: 10.1016/j.joms.2017.08.025. Epub 2017 Aug 24.

  PMID: 28923270 BACKGROUND

• Wang QQ, Dai R, Cao CY, Fang H, Han M, Li QL. One-time versus repeated abutment connection for platform-switched implant: A systematic review and meta-analysis. PLoS One. 2017 Oct 19;12(10):e0186385. doi: 10.1371/journal.pone.0186385. eCollection 2017.

  PMID: 29049323 BACKGROUND

Study Officials

• Weida Li

  Stomatological Hospital Affiliated to Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This study takes a single-blind method. During research process, the researchers cannot avoid knowing the type of abutment used by the subjects during the clinical examination and operation, so the subjects can only be single-blinded.The clinical examination data were measured and averaged by two independent clinicians. The data was analysed by a third person.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician, Deputy Director of Dental Implant Department

Model Details: The researchers prospectively and continuously recruited subjects who underwent implant therapy in the Oral Implantation Center of the Stomatology Hospital Affiliated to Zhejiang University School of Medicine, and all subjects who signed written informed consent were divided into 8 groups by random number table method: ① On1 abutment + Nobel Replace Conical Connection PMC implant group (hereinafter referred to as Nobel PMC), ②On1 abutment + Nobel Parallel™ Conical Connection implant group (hereinafter referred to as Nobel PCC), ③On1 abutment + Nobel Replace Conical Connection implant group (Hereinafter referred to as Nobel CC), ④ One-stage abutment + Nobel PMC implant set, ⑤ One-stage abutment + Nobel PCC implant set, ⑥ One-stage abutment + Nobel CC implant set.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: September 1, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)