Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment

Mouth, Edentulous Clinical Trial

— SIOver  

Official title:

Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment: Radiographic Evaluations, Patient's Satisfaction, and Oral-health-related Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801566
• Other study ID #: U1111-1129-9956
• Status: Completed
• Phase: N/A
• First received: February 25, 2013
• Last updated: March 14, 2016
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the treatment with single implant overdenture for the edentulous mandible. The investigators hypothesize that treatment with lower overdenture retained by a single implant appears to have satisfactory effectiveness as a treatment for patients with specific conditions (such as maladaptive patients), with the advantages of simplicity and greater immediate benefits when compared to the conventional full denture, improving the retention and stability of the denture and better oral-related quality of life.

Description:

This study is a longitudinal evaluation of clinical and patient-reported outcomes related to the single-implant mandibular overdenture treatment. Sixty completely edentulous individuals will be included. First, new complete dentures will be fabricated for all of them. Panoramic radiographs and conventional tomograms of the mandibular midline region will be obtained in order to plan the implant placement surgery. After the adaptation period related to the use of the new dentures, a single implant (Titamax IT Cortical, Neodent, Curitiba, Brazil) will be installed in the mandibular midline of all participants. According to the primary stability obtained in the implant placement patients will be treated with an immediate loading protocol when achieving torque of at least 30 Ncm and implant stability quotient (ISQ) of at least 60. In cases of values below cited, conventional loading protocol will be adopted. Ball O-ring will be used as the attachment system for the mandibular overdenture. Clinical and patient-reported outcomes will be collected after 1, 3, 6 and 12 months after the installation of the overdentures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Fully edentulous patients

• Need of replacement of the mandibular denture or patient without mandibular denture

• Patients with poor adaptation to the mandibular denture

• Patients with good general health

Exclusion Criteria:

• Patients who refuse to receive a conventional dentures opposed to a mandibular overdenture retained by a single implant

• Patients with local intraoral diseases that influence denture stability, retention and adaptation of the lower denture (such as changes or anatomical deformations of the jaws, mucosal changes caused by fungi and bacteria, tumor changes and absolute xerostomia)

• Patients with systemic, psychological or neurological diseases that preclude or hinder oral movements of the patient for clinical care and/or clinical follow-up in all stages of the research

• Patients who choose other treatment modalities not covered by the study

• Patients with alcoholism or other severe behavioral disorders that compromise their participation in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mouth, Edentulous

Intervention

Procedure:
• Single implant-retained mandibular overdenture
60 patients treated with single implant retained complete mandibular denture (overdenture) opposed to a conventional maxillary denture, allocated into 2 experimental groups according to the implant loading protocol (conventional and immediate), evaluated at baseline and after 1, 3, 6 and 12 months after treatment.

Locations

Country	Name	City	State
Brazil	School of Dentistry, Federal University of Goias	Goiania	Goias

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Goias	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary stability	Measures of the implant stability: stability quotient index and final insertion torque	Changes from baseline on primary stability of implants at 12 months	Yes
Other	Crestal bone loss	Periimplant alveolar bone height of the crestal bone level	Changes from baseline on crestal bone loss at 12 months	Yes
Other	Bone density around the implant	Periimplant bone density measured by digital subtraction radiography	Changes from baseline on bone density around the implant at 12 months	Yes
Primary	Oral health-related quality of life impacts	Oral health related quality of life impacts were measured using the Brazilian version of the Oral Health Impact Profile for Edentulous subjects (Souza et al., 2007; Souza et al., 2010), considering the overall scale and its four different scale domains: masticatory discomfort and disability (four items), (2) psychological discomfort and disability (five items), social disability (five items) and oral pain and discomfort (five items).	Change from baseline on oral health-related quality of life impacts at 12 months	Yes
Secondary	Satisfaction with dentures	Satisfaction with dentures measured using the patients' ratings of the overall satisfaction with the mandibular denture, and satisfaction with comfort, stability, esthetics, ability to speak, and ability to chew. All satisfaction items will be measured on a 10-point visual analogue scale ranging from 0 to 10	Change from baseline on satisfaction with dentures at 12 months	Yes

External Links

•   Website of the Main study sponsor