Ultrasonics Clinical Trial
Official title:
Long Term Comparison of Ultrasonic and Hand Instrumentation in the Maintenance of Peri-implant Tissues: A Randomized Clinical Trial
| Verified date | October 2015 |
| Source | University of Manitoba |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Nowadays, dental implants are a very attractive and affordable treatment option for
patients. According to the American Society of Implant Dentistry the dental implant market
in the U.S is projected to reach $1.3 billion by 20101. Despite the high success rates of
dental implants, it is clear that osseointegrated implants are susceptible to diseases. The
prevalence of dental implant complications are rising as the number of individuals that are
receiving implant treatment is also increasing. One of these peri-implant complications is
an inflammatory condition known as peri-implant mucositis that occurs in 64.6% to 80% of the
implant population.
The lack of preventive maintenance therapy in subjects with peri-implant mucositis is
associated with a high incidence of peri-implantitis, which eventually may lead to implant
loss. One important method in the prevention of peri-implant mucositis is the reduction in
plaque accumulation, through individual oral hygiene procedures and regular peri-implant
professional maintenance. It is highly important that patients be educated about the
importance of developing good oral hygiene habits and to attend regular periodontal
maintenance appointments. The clinicians have to recognize the significance of monitoring
and maintaining peri-implant health.
Unfortunately, it is unclear which of the different maintenance regimens and treatments
strategies for peri-implant mucositis and peri-implantitis are more effective. There is lack
of information about which peri-implant maintenance protocol offers the best outcome in
terms of reduction of inflammation and improved patient comfort. According to Grusovin et
al, "there is only low quality evidence for which are the most effective interventions for
maintaining or recovering health of peri-implant soft tissues and there is no reliable
evidence as to which regimens are most effective for long term maintenance". Moreover,
current approaches to implant maintenance are somewhat haphazard and not standardized.
It is assumed that what is appropriate for teeth is also beneficial for implants; as stated
by Persson et al, 2010 "therapies proposed for the management of peri-implant diseases are
currently based on the evidence available from the treatment of periodontitis". Two
conventionally used methods of biofilm and calculus removal from teeth in North America are
hand instruments (curettes and scalers) and ultrasonics. In teeth these two modalities of
treatment have been studied extensively; conversely, there are fewer studies on dental
implants. Renvert et al, 2008 concluded that mechanical non-surgical treatment might be
effective to treat peri-implant mucositis but not peri-implantitis; however, the data
supporting this literature review was scarce. The same research group compared ultrasonic
instrumentation with specific-implant tips to titanium curettes in the treatment of
peri-implantitis founding no group differences in the treatment outcomes with improvements
in plaque and bleeding scores but no effects on probing depths. In addition, both methods
failed to eliminate or reduce bacterial counts and no group differences were found in the
ability to reduce the microbiota in a six months period.
One of the main concerns for dental implants is that metal scalers and ultrasonics generate
a roughened surface on the implant, which in turn facilitates plaque accumulation and
therefore makes maintenance of plaque free surfaces more difficult. It was observed in a
recent study that special coated scalers and ultrasonic tips have been shown in vitro to be
compatible with implant surfaces, however this has not been confirmed in vivo. The previous
finding is in agreement with a current study, which demonstrated that the roughness values
of the titanium surface of implants treated with piezoelectric ultrasonic scalers with a
newly developed metallic tip and plastic hand curettes, are equal to the surface's roughness
of untreated implants. Mann et al, 2012 showed in an in vitro study that plastic-coated
scalers cause minimal damage to the implant surface but leave plastic deposits behind on the
implant surface, suggesting further research is needed to evaluate the use of such plastic
tips in the debridement of implants.
An additional factor, in evaluating the efficacy of different instrumentation in
peri-implant maintenance, which needs to be taken into consideration, is patient perception.
There is currently no data evaluating patient perception of comfort in regards to hand vs.
ultrasonic instrumentation. This information is very important because should both methods
of debridement be considered of equal efficacy, patient preference may play a role in the
practitioner's selection of instrumentation. Knowing that patient comfort will increase the
patient's compliance to the maintenance therapy, further evaluation of this factor is
necessary.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients with healthy peri-implant tissues and implants with peri-implant mucositis Exclusion Criteria: - All others |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Manitoba Faculty of Dentistry Periodontics Clinic | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manitoba |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Cytokines | 12 Months | ||
| Other | Patient comfort | 12 Months | ||
| Other | Bleeding scores | 12 Months | ||
| Primary | Reduction of inflammation | 12 Months | ||
| Secondary | Probing depths | 0 - 3 - 6 - 9 and 12 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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