Single Versus Two Dental Implant Retained Mandibular Overdenture: Study Protocol for a Randomized Controlled Trial
Pravinkumar GP*, Liang LS and Mohana T
International Medical University, Kuala Lumpur, Malaysia
- *Corresponding Author:
- Pravinkumar G. Patil
School of Dentistry, International Medical University
Kuala Lumpur, Malaysia
E-mail: [email protected]
Received: September 08, 2015; Accepted: January 31, 2016; Published: February 10, 2016
Citation: Pravinkumar GP, Liang LS, Mohana T (2016) Single Versus Two Dental Implant Retained Mandibular Overdenture: Study Protocol for a Randomized Controlled Trial. Dial Clin Pract 1:104. doi:10.4172/2572-4835.1000104
Copyright: © 2016 Pravinkumar GP, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: The consensus is that the standard treatment of choice for the edentulous mandible should be a two implant retained mandibular overdenture. Some clinicians have tried single median implant to retain the mandibular overdenture, however, there is lack of scientific information with single implant retained mandibular overdenture. Therefore the purpose of the current randomized clinical trial is to test the hypothesis that a single median implant in edentulous mandible will result in a clinical outcome comparable to two implants. Methods/design: This prospective randomized controlled clinical trial is in preparation to commence. The final patient with 1 year follow up will complete the trial in 2017. In total, 66 edentulouspatients between 45 and 85 years of age with mandibular complete dentures will be treated with either single median implant (experimental group, N=33) or two implants (control group, N=33). The existing complete dentures will immediately be supported by the implants using locator attachment/s. The patients will be followed up at intervals of 1 month and 12 months after implant loading. The primary outcome measures are implant success rate, masticatory performance and patient satisfaction level and. The secondary outcome measures encompass effect on oral health related quality of life and clinical, technical and subjective variables. Discussion: This clinical trial will give information on the ability of single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option is advantageous in regards to simpler procedure, reduced treatment cost and reduced risk of surgical morbidity.