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

NCT02123420 | Completed

• 1 other identifier: PS vs RP
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Missing Teeth

Keywords

Platform Switching vs Regular Platform

Outcome Measures

Primary Outcomes (1)

• Implant Survival

  implant survival: The removal of implants was dictated by instability, progressive marginal bone loss, infection or implant fracture.

  Up to 12 months

Secondary Outcomes (1)

• Change in marginal bone levels

  Baseline, 12 months

Other Outcomes (1)

• Change in peri-implant mucosal response parameters.

  Baseline, 12 months

Study Arms (2)

Implant outcome

OTHER

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)

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

Implant outome

OTHER

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)

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

Interventions

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

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

Implant outcome; Implant outome

Eligibility Criteria

• Age: 24 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Phd, MS

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 25, 2014
• Study Start: November 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 25, 2014

Record last verified: 2014-04