Clinical and Radiographic Comparison of Two Implant-Abutment Connections

NCT07889882 | Not Yet Recruiting DMC

• 2 other identifiers: BGA26012026-1873
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study is to evaluate two different implant-abutment connection design on preserves gingiva and bone health in the long term. As part of this study, two different implant systems will be applied to the posterior edentulous areas on both sides of the mouth. Implants featuring a new macro-design and a special surface technology (TiUltra surface and N1 system), aimed at accelerating tissue healing, will be placed in one area; meanwhile, implants with a conical design and the same special surface technology, which are widely used in clinical practice (Nobel Active), will be placed in the other area. Procedure for Participants First, an intraoral examination will be performed, and CBCT will be taken to assess suitability for the procedure. Surgical Procedure: Implant placement. Prosthetic Phase: Once healing is complete, impressions will be taken, and porcelain teeth will be placed on the implants. Follow-up Appointments: Follow-ups will be conducted at 1, 3, 6, and 12 months following the placement of the teeth. During these check-ups, gingiva health will be assessed, and X-rays will be taken to observe changes in bone levels.

Conditions

Dental Implant; Edentulous Alveolar Ridge

Keywords

posterior mandible; posterior maxilla; edentulous; dental implant; connection design

Outcome Measures

Primary Outcomes (1)

• Marginal bone level changes (mm)

  The primary outcome measure will be ΔMBL (Marginal bone level changes) at T0 (prosthetic loading) -T4 (12 months follow-up) on periapical radiographs

  12 months follow-up

Secondary Outcomes (2)

• Correlation between marginal bone level changes and other parameters

  12 months follow-up

• Primary and secondary outcomes (ISQ)

  At operation and follow-up 3 months (at prosthetic loading)

Study Arms (2)

N1

EXPERIMENTAL

Following dental implant placement (Nobel Biocare, N1 Implant system, Switzerland), an N1 Base and healing abutment will be immediately placed at intraoperatively and a temporary crown will be delivered at the same day. After three months, N1 universal abutments with porcelain-fused metal, screw-retained prosthetic restorations will be delivered.

Procedure: N1 Dental implant placement + N1 abutment

On1

EXPERIMENTAL

Following dental implant placement (Nobel Biocare, TiUltra Active, Switzerland), an On1 Base and healing abutments will be immediately placed at intraoperatively, and a temporary crown will be delivered at the same day. After three months, On1 universal abutments with porcelain-fused metal, screw-retained prosthetic restorations will be delivered.

Procedure: Nobel active Implant placement + on1 abutment

Interventions

N1 Dental implant placement + N1 abutment PROCEDURE

All implants will be placed by the same 15-year-experienced periodontist (B.G.A) under local anesthesia with a crestal incision and flap elevation. For the N1 group, the implant site is prepared using the OsseoDirector at 600-800 rpm with irrigation to determine direction and depth. The osteotomy is then prepared with OsseoShaper™ 1 at 50 rpm without irrigation. A Nobel Biocare N1™ Implant will be inserted subcrestally at 25 rpm with a 35 Ncm insertion torque. Based on supracrestal tissue height (1.75-2.5 mm), an N1 Base Xeal abutment will be torqued to 25-30 N-cm. An N1 healing abutment will be fitted, and the site closed with 4-0 Vicryl sutures. An N1 temporary abutment and a temporary crown with \~1 mm infraocclusion will be delivered on the same day. After 3 months, N1 universal abutments will be torqued, and screw-retained porcelain-fused-to-metal final restorations will be delivered.

N1

Nobel active Implant placement + on1 abutment PROCEDURE

All implants will be placed by the same 15-year-experienced periodontist (B.G.A) under local anesthesia with a crestal incision and flap elevation. For the on1 group, osteotomy preparations are performed at 600-800 rpm, after which the Nobel TiUltra Active implants are placed subcrestally with an insertion torque of 35 Ncm. Based on supracrestal tissue height (1.75-2.5 mm), an On1 Base Xeal abutment will be torqued to 25-30 N-cm. An On1 healing abutment will be fitted, and the site closed with 4-0 Vicryl sutures. An On1 temporary abutment and a temporary crown with \~1 mm infraocclusion will be delivered on the same day. After 3 months, On1 universal abutments will be torqued, and screw-retained porcelain-fused-to-metal final restorations will be delivered.

On1

Eligibility Criteria

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

You may qualify if:

• age\>18 years old,
• patients have two posterior single edentulous fully-healed sites at different quadrants,
• sufficient alveolar width without the need for additional alveolar augmentation or immediate bone grafting, as assessed by Cone Beam Computed Tomography (CBCT),
• cooperated,
• systemically healthy patients.

You may not qualify if:

• pregnancy and breastfeeding,
• individuals with intellectual disabilities,
• immediate implant placement,
• Untreated periodontitis (Full mouth plaque score \> 20%, full mouth bleeding score \> 25%, residual pocket depth \> 5 mm),
• heavy smoking (\>10 cigarettes/day),
• usage drugs that suppress the immune system or impair recovery or that disrupt bone metabolism such as chemotherapy, radiotherapy etc.,
• severe bruxism or clenching,
• bone augmentation during implant surgery,
• prosthetic contraindications,
• penicillin allergy history.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead
• Nobel Biocare: collaborator

Study Sites (1)

Kütahya Health Sciences University Gülsüm Güral Oral and Dental Health Application and Research Center

Kütahya, 43020, Turkey (Türkiye)

Location

Related Publications (7)

• Wennerberg A, Albrektsson T, Chrcanovic B. Long-term clinical outcome of implants with different surface modifications. Eur J Oral Implantol. 2018;11 Suppl 1:S123-S136.

  PMID: 30109304 BACKGROUND

• Chen CH, Coyac BR, Arioka M, Leahy B, Tulu US, Aghvami M, Holst S, Hoffmann W, Quarry A, Bahat O, Salmon B, Brunski JB, Helms JA. A Novel Osteotomy Preparation Technique to Preserve Implant Site Viability and Enhance Osteogenesis. J Clin Med. 2019 Feb 1;8(2):170. doi: 10.3390/jcm8020170.

  PMID: 30717291 BACKGROUND

• Fabbri G, Staas T, Urban I. A Retrospective Observational Study Assessing the Clinical Outcomes of a Novel Implant System with Low-Speed Site Preparation Protocol and Tri-Oval Implant Geometry. J Clin Med. 2022 Aug 18;11(16):4859. doi: 10.3390/jcm11164859.

  PMID: 36013098 BACKGROUND

• Nosswitz M, Teale M, Mathes S, et al. Evaluation of anodized surfaces designed for improved soft tissue integration. Foundation for Oral Rehabilitation (FOR) 2019;1-7.

  BACKGROUND

• Ayyildiz BG, Terzioglu B, Bayindir BC. The Effect of Two-Piece Abutment Concept and Abutment Reconnection/Disconnection on Marginal Bone Level Changes: A Split-Mouth Randomized, Parallel-Designed, 36-Month Follow-Up, Preliminary Clinical Study. Int J Oral Maxillofac Implants. 2025 Sep 4;0(0):1-28. doi: 10.11607/jomi.11454. Online ahead of print.

  PMID: 40907027 BACKGROUND

• Laleman I, Lambert F. Implant connection and abutment selection as a predisposing and/or precipitating factor for peri-implant diseases: A review. Clin Implant Dent Relat Res. 2023 Aug;25(4):723-733. doi: 10.1111/cid.13185. Epub 2023 Feb 24.

  PMID: 36825512 BACKGROUND

• Yeung SC. Biological basis for soft tissue management in implant dentistry. Aust Dent J. 2008 Jun;53 Suppl 1:S39-42. doi: 10.1111/j.1834-7819.2008.00040.x.

  PMID: 18498584 BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Central Study Contacts

Berceste Guler Ayyildiz, Assoc. Prof. Dr.

CONTACT

+90 02742300056; berceste.guler@ksbu.edu.tr

Busra Terzioglu, Assist. Prof. Dr.

CONTACT

+905345228670; busra.ozaltun@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Before the implant surgery, allocation of implants to the test and control groups will be performed using a closed-envelope randomization method. In this split mouth design, implant sites will be coded as 'left' and 'right' and will be placed into sealed envelopes. One of the envelopes will be randomly selected by the patient, and the site indicated will be assigned to the test group, while the implant on the contralateral side will serve as the control. The patients and calibrated researcher (H.A.) for radiographic measurements will be blinded. All clinical measurements will be recorded by blinded, experienced, calibrated periodontists (B.T. and S.E.)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Model Details: A prospective, split-mouth, randomized, parallel-designed, blinded, clinical trial.

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 22, 2026
• Study Start (Estimated): October 26, 2026
• Primary Completion (Estimated): June 5, 2029
• Study Completion (Estimated): September 5, 2029
• Last Updated: October 22, 2026

Record last verified: 2026-10

Locations

TU (1)