Clinical and Radiographic Comparison of Two Implant-Abutment Connections

Condition(s) studied

Investigational drug(s) / intervention(s)

N1 Dental implant placement + N1 abutment: 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.

Nobel active Implant placement + on1 abutment: 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.

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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