Platform Switching vs Regular Platform Implants. One Year Results From a RCT

NCT ID: NCT02123420

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-02-28

Brief Summary

The present study tested the hypothesis that Platform Switching (PS) and Regular Platform (RP) implants would have different outcomes in the bilateral single tooth replacements against the alternative hypothesis of no difference.

Detailed Description

This study was designed as a randomised, controlled, split-mouth trial. Eighteen patients, with bilaterally missing single bicuspid or molar had one of the sites to be restored randomly assigned to be treated according to the platform-switching concept with (PS group), or with matching implant-abutment diameters, (RP group). A total of 36 implants, (18 Nobel Replace Tapered Groovy PS, 18 Nobel Replace Tapered Groovy), were bilaterally installed. All the implants were inserted with an insertion torque between 35 and 45 Ncm, in healed healthy bone and the healing abutment was connected at the same time. Both implants were delayed loaded with screw retained temporary crowns 3 months after implant insertion and with screw retained definitive crowns 2 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, soft tissue parameters (PPD and BOP). Clinical data were collected at baseline 6 and 12 months. Statistical analyses were conducted using computational program SAS (version 9.2), with 1-away ANOVA and F-test. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation with 95% confidence intervals.

Conditions

Missing Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Implant outcome

This study was designed as a randomised, controlled, split-mouth trial. all enrolled patients needed single bilateral fixed implant-supported prosthesis in molar area.

A total of 18 consecutive patients were enrolled. In each eligible patient, the right molar was randomly selected to receive either Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Goteborg, Sweden) with Platform Switching (PS) or Regular Platform (RP)

Group Type: OTHER

Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden)

Intervention Type: DEVICE

Both sites received tapered implants with an anodised surface, one site received: Nobel Replace Tapered Groovy PS implant; (Nobel Biocare, Goteborg, Sweden), with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (PS group), the contralateral site received Nobel Replace Tapered Groovy implant with Replace Select connection with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (RP group).

Healing abutments were connected to implants at the same time of surgery , then flaps were sutured with Vicryl 4.0 sutures (Vicryl, Ethicon J&J International, St-Stevens-Woluwe, Belgium).

Implant outome

This study was designed as a randomised, controlled, split-mouth trial. all enrolled patients needed single bilateral fixed implant-supported prosthesis in molar area.

A total of 18 consecutive patients were enrolled. In each eligible patient, the left molar was randomly selected to receive either Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Goteborg, Sweden) with Platform Switching (PS) or Regular Platform (RP)

Group Type: OTHER

Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden)

Intervention Type: DEVICE

Both sites received tapered implants with an anodised surface, one site received: Nobel Replace Tapered Groovy PS implant; (Nobel Biocare, Goteborg, Sweden), with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (PS group), the contralateral site received Nobel Replace Tapered Groovy implant with Replace Select connection with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (RP group).

Healing abutments were connected to implants at the same time of surgery , then flaps were sutured with Vicryl 4.0 sutures (Vicryl, Ethicon J&J International, St-Stevens-Woluwe, Belgium).

Interventions

Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden)

Both sites received tapered implants with an anodised surface, one site received: Nobel Replace Tapered Groovy PS implant; (Nobel Biocare, Goteborg, Sweden), with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (PS group), the contralateral site received Nobel Replace Tapered Groovy implant with Replace Select connection with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (RP group).

Healing abutments were connected to implants at the same time of surgery , then flaps were sutured with Vicryl 4.0 sutures (Vicryl, Ethicon J&J International, St-Stevens-Woluwe, Belgium).

Intervention Type: DEVICE

Other Intervention Names

Nobel Replace Tapered Groovy PS implant; (Nobel Biocare®, Sweden); Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)

Eligibility Criteria

Inclusion Criteria

• need for single bilateral fixed implant-supported prosthesis in molar area
• stable interocclusal contacts
• ≥18 years of age
• provided written informed consent
• residual bone height ≥10 mm
• residual bone thickness ≥6 mm with at least 5 mm of keratinised gingiva crestally

Exclusion Criteria

• general contraindications to implant surgery
• lack of occluding dentition in the area intended for immediate loading
• periodontitis
• bruxism
• immunosuppression
• previous history of irradiation of the head and neck area
• uncontrolled diabetes
• heavy smoker (>10 cigarettes/day)
• poor oral hygiene
• current or past treatment with bisphosphonates
• substance abuse
• psychiatric disorder
• inability to complete follow-up ≥1 year
• lactation
• implant insertion torque less than 35 Ncm

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Sassari

OTHER

Sponsor Role: lead

Responsible Party

Silvio Mario Meloni

DDS, Phd, MS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PS vs RP

Identifier Type: -

Identifier Source: org_study_id