Clinical and Radiographic Comparison of Dental Implants With Trioval and Conical Implant-Abutment Connections
| Registry | NCT07889882 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 20 (Estimated) |
| Sponsor | Kutahya Health Sciences University (Other); collaborators: Nobel Biocare |
| Conditions | Dental Implant, Edentulous Alveolar Ridge |
| Interventions | N1 Dental implant placement + N1 abutment, Nobel active Implant placement + on1 abutment (Procedure) |
| Dates | start 2026-10-26 (estimated), primary completion 2029-06-05 (estimated), completion 2029-09-05 (estimated), first posted 2026-10-22, last updated 2026-10-22 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Dental Implant All trials for Edentulous Alveolar Ridge All trials of N1 Dental implant placement + N1 abutment All trials of Nobel active Implant placement + on1 abutment
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.
This study aims to compare the effect of the N1 implant system, featuring a new macro design with a TiUltra surface and a trioval implant-abutment connection placed in the posterior region as a splitmouth in single-unit implants, with that of Xeal abutments on Nobel Active conical connection implants, also featuring a TiUltra surface, on peri-implant marginal bone loss.
The stability of both soft and hard tissues is crucial for maintaining long-term peri-implant tissue health. In this context, various surface modifications have been studied to enhance osseointegration. Developed in recent years to optimize tissue integration at all levels of the implant, TiUltra™ surface features an ultra-hydrophilic, multi-zone, and anodized surface architecture. The TiUltra™ surface topography gradually changes from the implant neck to the apex, providing a biocompatible and stable surface at the soft tissue level while supporting osseointegration with a moderately rough and porous structure at the apex. A healthy soft tissue barrier, defined as peri-implant soft tissue integration (mucointegration), plays a critical role in protecting peri-implant bone by preventing bacterial colonization and related inflammatory processes. Therefore, in recent years, focus has been placed on implant and abutment connection design, surface topography, and surface chemistry. Various strategies have been used to maintain peri-implant tissue stability, including platform switching, transmucosal abutments, two-piece abutments, and modifications to the implant collar and implant-abutment interface, such as one-abutment one-time concepts. A new biology-driven implant concept has also been developed to improve osseointegration and mucointegration: the Nobel Biocare N1™ system. The system: It is based on a biological concept that combines the OsseoShaper™ cutting tool, which protects vital bone with low speed, irrigation-free operation, the OsseoDirector™, which guides implant positioning, the Xeal surfaced On1 abutment, and the TiUltra-surfaced N1 implant.
All implants will be placed using standard surgical protocols by the same brand. The implants will be placed in both groups during the same session. Local anesthesia will be achieved in surgical areas using the bilateral vestibular infiltration technique. A crestal incision will be made using a size 15 scalpel, and the mucoperiosteal flap will be elevated. In the test group, following the manufacturer's protocol, the implant site. The Nobel Biocare N1™ Implant will insert subcrestally at 25 rpm with an insertion torque of 35 Ncm. In the control 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. Following primary stabilization, the heights of the definitive two-piece abutments will be determined at the time of implant placement surgery based on the supracrestal tissue height, with heights of 1.75 mm and 2.5 mm recorded in both groups. The On1/N1 healing abutment will then be fitted on N1/On1 Base, and the surgical field will be sutured. The dental implant sites will primarily be closed with 4-0 resorbable Vicryl sutures. On1/N1 Temporary abutments will be placed, and temporary crowns will be delivered at the same day with operation day. After implant placement, a temporary abutment designed explicitly for temporary prosthesis application and a temporary prosthesis with approximately 1 mm infraocclusion will be fabricated. Following the dental implant treatment after 3 months, On1/N1 universal abutments will be torqued and screwed-retained porcelain fused to metal prosthetic final restorations will be delivered.
Clinical and Intraoperative Measurements Before the operation, keratinized mucosal width (KMW) and mucosal thickness (MT) will be measured at baseline (Tb).
Peri-implant clinical measurements: modified plaque index (mPI), modified gingival index (mGI), periodontal pocket depth (PD), bleeding on probing % (BOP%), KMW, and MT will be recorded at permanent prosthetic functional loading (T0), 1 month (T1), 3 month (T2), 6 months (T3), and 12 months (T4) following prosthetic functional loading. Mesial and distal adjacent to single-unit dental implants will be recorded as tooth or edentulous. Intraoperatively, implant placement depth at mesial, distal, buccal, and lingual aspects will be recorded. And also, supracrestal tissue height will be measured.
Digital aesthetic assessment in the study will be performed by superimposing intraoral scans and radiological images on a digital platform.
Marginal bone level will be measured in standardized periapical digital radiographs. Periapical radiographs will be obtained with the parallel long-cone technique with O-ring film-holder after immediately implant placement, at prosthesis functional loading (following 4 months of implant placement) (T0), 1 month (T1), 3 month (T2), 6 months (T3), and 12 months (T4) after prosthesis loading.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| N1 | Experimental | Procedure: N1 Dental implant placement + N1 abutment | 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. |
| On1 | Experimental | Procedure: Nobel active Implant placement + on1 abutment | 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Kütahya Health Sciences University Gülsüm Güral Oral and Dental Health Application and Research Center | Kütahya | Turkey (Türkiye) |