A Randomised Controlled Clinical Trial comparing the results of the Immediate Loading (within 48 hours) of Mandibular Overdentures supported by either 2 standard Straumann dental implants or 4 Mini Dental Implants (MDIs).

A Randomised Controlled Clinical Trial comparing the results of the Immediate Loading (within 48 hours) of Mandibular Overdentures supported by either 2 standard Straumann dental implants or 4 Mini Dental Implants (MDIs). - RCT on 2 different immediate loading protocols to support overdentures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38808

Enrollment

Registered

2013-09-02

Start date

2013-07-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

de edentate mandibula (prothese met weinig retentie) edentulous mandible (lower jaw)

Interventions

Immediate loading (within 48 hours) of two interconnected implants with an overdenture (Control group) Immediate loading (within 48 hours) of 4 mini implants and an overdenture in patients with adeq

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Patients that have been completely edentulous for at least 6 months. *Patients that have a maladaptive mandibular denture *Patients that have enough bone volume for an implant length of at least 10 mm and diameter of 3.3 mm measured on a CBCT *Presence of a maxillary complete denture *Presence of keratinised tissue around the proposed implant site *Presence of suitable bone quality (type 1-3) as assessed radiographically (Lekholm & Zarb classification) *The patient agrees to a treatment allocation in any of the two groups *The patient is willing and able to give informed consent

Exclusion criteria

Exclusion criteria: *Insufficient bone volume (

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is to analyse the marginal bone loss around immediately loaded standard Straumann implants and Mini Dental Implants used to support mandibular overdentures.	—

Secondary

Measure	Time frame
1.Clinical parameters related to implants plaque index bleeding index probing depth assessment of soft tissue. 2.The level of satisfaction of the patients in terms of function, aesthetics, phonetics, mastication, retention of the dentures anchored with the different implant types and the overall quality of life before and after treatment will be also investigated. 3.Frequency and type of technical complications of the superstructure 4.Cumulative implant success rate Success will be based on clinical and radiographic criteria to describe implant performance as defined by Albrektsson et al. 1986 and adapted by Buser et al. 1997 as well as Karoussis et al. 2004, Roos-Janseker et al. 2006a, b, and Renvert et al. 2007: Absence of persistent subjective complaints (pain, foreign body sensation and/or dysaesthesia) Absence of recurrent peri-implant infection with suppuration Absence of mobility Absence of a continuous radiolucency around the implant No PPD 5mm and bleeding on probing (POB) Peri-implant bone loss 1.5 mm during the first year of function. After the first year of service, the annual vertical bone loss should not exceed 0.2 mm (mesially or distally) 5.Cost analysis	—

Measure

Time frame

1.Clinical parameters related to implants *plaque index *bleeding index *probing depth *assessment of soft tissue. 2.The level of satisfaction of the patients in terms of function, aesthetics, phonetics, mastication, retention of the dentures anchored with the different implant types and the overall quality of life before and after treatment will be also investigated. 3.Frequency and type of technical complications of the superstructure 4.Cumulative implant success rate Success will be based on clinical and radiographic criteria to describe implant performance as defined by Albrektsson et al. 1986 and adapted by Buser et al. 1997 as well as Karoussis et al. 2004, Roos-Janseker et al. 2006a, b, and Renvert et al. 2007: *Absence of persistent subjective complaints (pain, foreign body sensation and/or dysaesthesia) *Absence of recurrent peri-implant infection with suppuration *Absence of mobility *Absence of a continuous radiolucency around the implant *No PPD * 5mm and bleeding on probing (POB) *Peri-implant bone loss *1.5 mm during the first year of function. After the first year of service, the annual vertical bone loss should not exceed 0.2 mm (mesially or distally) 5.Cost analysis

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)