Edentulous Mouth Clinical Trial
Official title:
Clinical Outcomes Using Different Attachment Types for Single-implant Mandibular Overdentures: a Crossover Clinical Trial
Dental implants are often the preferred treatment option and in some clinical scenarios they are considered the standard of care to restore missing or damaged teeth, due to the limitations of conventional treatments. For fully edentulous subjects, conventional tissue-supported dentures in some cases are associated with severe subjective complaints and difficult adaptation, mainly the mandibular denture, resulting in limited function and detrimental effects on oral health-related quality of life, especially for older patients. The use of implants to retain a mandibular denture (overdenture) has been recommended as a suitable and low-cost alternative to improve denture stability, with positive effects on oral comfort and function. The two-implant mandibular overdenture has been considered an effective design to achieve clinical benefits for patients. However, the main problem facing two-implant overdenture is the high cost of implantation and the relative complexity of the surgical intervention, so the use of a single midline implant to retain a mandibular overdenture was suggested as a more viable solution for reducing costs and complexity of treatment with similar benefits compared to solutions with higher number of implants. Nevertheless, there are few studies that compared the performance of different retention systems and their effects on patient-centered outcomes, such as satisfaction with the dentures, oral health-related quality of life, individual preferences and other subjective ratings of clinical outcomes. Thus, the aim of this randomized clinical trial with a crossover design is to investigate the changes in clinical and patient-reported outcomes following the use of different retention systems for a single implant-retained mandibular overdenture Hypothesis: it was hypothesized that clinical and patient-reported outcomes of a single-implant mandibular overdenture is dependent on the type of retention system, and patients have distinct preferences in relation to different attachments
The absence of all natural teeth has negative effects on edentulous subjects' quality of
life. It affects badly the masticatory muscles, chewing efficiency and digestive process,
ability to speak clearly, psycho-social impacts related to esthetics and non-self-confidence
and it is often associated with increasing risk for chronic systemic diseases.
In Brazil, tooth loss is still a public health problem with high prevalence and negative
impacts on the lives of individuals, despite the possibility of control by means of
preventive and rehabilitation technologies aimed at promoting oral health. The prevalence of
tooth loss is 76.6% in the general population, with a median of 6 teeth lost for the
population aged 15 or more years old. There is a high prevalence of edentulism in the 65-74
years age group for the maxilla (63.1%) and mandible (37.5%). Epidemiological data showed
that there was an improvement in the oral health status of adults as the demand for dentures.
However, the major problem is still concentrated in the population aged 65 to 74, who had an
average caries index rate of 27.1 in 2010 (in 2003 the average was 27.8) with a predominance
of component lost by decay. From 2003 to 2010, the proportion of elderly people who need
dentures dropped from 24% to 23% and from 16% to 15% for those who need partial dentures.
Although treatments using implants are widely available, conventional complete dentures are
still an important part of oral health care for edentulous individuals, mainly due to
economic reasons. However, conventional complete dentures do not always achieve all treatment
goals regarding patient satisfaction and function, as a number of edentulous patients have
problems with their dentures related to retention and comfort during mastication and speech,
especially for the mandibular denture.
The limitations of conventional dentures make the implant-supported mandibular overdenture be
considered the preferred option for a number of edentulous elders. As stabilization by
implants can increase denture retention and stability, improve masticatory efficiency and
patient satisfaction. Furthermore, there are scientific evidences that it also contributes
for prevention of bone resorption.
The mandibular overdenture retained by two implants has been recommended as the minimum
standard of care for the edentulous mandible. However, these consensus reports consider that
anything less is negligent care disregard who cannot afford two implants, so the main problem
related to implant overdenture is higher financial costs compared to the conventional
complete denture. This is inconsistent with treatment concepts for the elderly, which include
simplicity and cost effectiveness as major requirements in treatment planning.
In recent years, the single-implant mandibular overdenture has been proposed as an
alternative to more complex overdenture designs for the treatment of mandibular edentulism.
This treatment approach is assumed to be simpler and less costly than both the fixed implant
treatment and the overdenture retained by two implants. It is also considered a more feasible
option for geriatric patient groups because of their diminished functional demands and the
favorable local bone condition in the symphyseal region that ensures satisfactory primary
implant stability.
A series of clinical studies showed satisfactory results of the single-implant mandibular
overdenture treatment regarding patient satisfaction and quality of life measures, as well as
other clinical and radiographic outcomes such as implant survival rate, marginal bone loss
and longitudinal implant stability. Although these studies differed on the experimental
design, use of different implant and retention systems, loading protocols and evaluation of
distinct clinical outcomes, they agree that the use of a single implant to retain an
overdenture results in marked improvements compared to the conventional treatment Attachment
systems used for implant-retained overdentures are small interlocking devices which links the
implant with the dentures and this offer many balanced solutions between functions and oral
comfort. The attachment systems allow an improvement in masticatory function, bite forces,
food selection and quality of life. The retention design can be classified as mechanical,
friction fit or magnetic. There are various attachments available for the clinicians in the
market today such as bar connections, ball attachments, magnets, rigid or non-rigid
telescopic copings and stud attachments.
Clinical studies also reported complications related to the clinical performance of
attachment systems used for single-implant mandibular overdentures. Loss of retention and
matrix replacement was one of the most common maintenance events in single mandibular
overdenture patients, although some studies reported no need for replacement in the long-term
follow-up. Studies showed great variation on the incidence of matrix replacement, although no
comparison of different types of retention systems and no time-to-event analysis were
reported. No difference between the incidence of repair and adjustments of mandibular
overdentures supported by 1 or 2 implants was observed.
The impact of different attachment types on patient satisfaction and quality of life is
recognized as a critical outcome requiring further investigation. For single-implant
mandibular overdentures, studies reported in their majority the use of ball-o'ring, magnet
and stud attachment systems. However, no evidences of the superiority of one system over
another are available, considering both patient-reported outcomes such as individual
preferences, easy to handle and oral comfort; and technical criteria such as level of
retention, longevity, retrievability and the need of adjustments and replacement.
This study will focus in improving patient health care quality, satisfaction and treatment
outcomes as it is considered the golden goal for studying clinical benefits from treatments
by comparing between different types of attachments for single-implant mandibular overdenture
treatment. This will be an experimental study using a randomized clinical trial with a
crossover design to test if clinical and patient-reported outcomes are dependent on the type
of retention system, and if patients have distinct preferences about the tested attachments.
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