Ultrasonics Clinical Trial
Official title:
Long Term Comparison of Ultrasonic and Hand Instrumentation in the Maintenance of Peri-implant Tissues: A Randomized Clinical Trial
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.
Long term comparison of ultrasonic and hand instrumentation in the maintenance of
peri-implant tissues: A randomized clinical trial
Objective
The aim of this study is to determine the clinical effects, presence of inflammatory
cytokines, and the patients' perceived discomfort by comparing titanium scalers to
ultrasonic instrumentation using implant inserts in a patient population with healthy
peri-implant tissues and implants with peri-implant mucositis during a one-year period of
peri-implant maintenance.
Hypothesis
There are insufficient studies in the literature to guide the clinician which technique will
offer better results in maintaining health or in decreasing inflammation long term around
dental implants during peri-implant maintenance. It is postulated in this study that (1)
peri-implant therapy will have a beneficial clinical effect, will decrease the presence of
inflammatory cytokines and will be well tolerated by the patient population and that (2)
there will be no differences in the outcomes between the two peri-implant maintenance
therapies.
Materials and Methods
Previous approval by the Biomedical Research Ethics Board of the University of Manitoba a
randomized clinical trial will be conducted between May, 2014 and May, 2015 at the
Periodontics Clinic of the University of Manitoba. The Oral Biology Laboratory of the
University of Manitoba will perform the analysis of samples of the peri-implant crevicular
fluid. The Consolidated Standards of Reporting Trials, CONSORT Statement will be followed.
66 participants with at least one single dental implant will be recruited and randomly
assigned to one of the two peri-implant maintenance groups. Subjects enrolled in the study
will be regular patients of the Periodontics Graduated Clinic at the University of Manitoba,
Faculty of Dentistry. Each participant will sign a written informed consent. The
randomization will be computer-generated by a second person not involved in the study.
A total of 352 sites (6sites/implant) will be studied. Cohen effect size has been used to
calculate the sample size. Small to medium effect size ranges by Cohen: 0.2mm to 0.5mm. In
addition, independent t-test with alpha=0.05, power (1-beta) =80%, 95% confidence interval
and two tailed test. Allocation ratio, n1/n2=1. G*Power 3.1.7 software was used in sample
size calculation. An attrition rate of 6 participants was calculated.
A code will be assigned to each participant. Only the research coordinator will have access
to the patients/codes matching list and its corresponding therapy. The peri-implant
maintenance will be performed by two experienced Dental Hygienists previous intra and
inter-examiner calibration. A single blinded calibrated examiner (MC) will do the recording
of clinical findings and sampling at baseline, 3, 6 and 12 months.
The following are the inclusion criteria: (1) subjects having at least one single unit
dental implant (2) probing depths no more than 5mm in 6 aspects around each implant (MB, B,
DB, ML, L and DL), (3) no bone loss beyond 2mm/implant at baseline confirmed with periapical
radiographs with a cone paralleling technique. The next criteria will be excluded from the
study: (1) implant supported removable prostheses, (2) use of antibiotics within the
preceding 3 months (3) smokers (4) missing exam at baseline.
The parameters to be assessed at 6 sites/implant are the following: (1) Modified plaque
index by Mombelli (2) Modified gingival index by Mombelli, (3) probing depths (PD), (4)
presence of keratinized gingiva (0, 0.5-1.5mm, 2 or greater), (5) recession (REC) distance
between gingival margin and most occlusal point of restoration, (6) Cytokine levels in
peri-implant crevicular fluid, 1 sample from the deepest site of implant(s) will be
collected at baseline, 3, 6 and 12 months. In addition, patients will also be asked to fill
in a pain questionnaire at the end of the study period (Visual analogue scale, VAS).
To collect the peri-implant crevicular fluid, the site will be isolated from saliva using
cotton rolls and drying before the sampling. Periopaper strips (Oraflow) will be introduced
at the deepest site of the implant sulcus for 30 sec. The volume of peri-implant crevicular
fluid will be measured using a Periotron. Until further analysis strips will be store at
-80C in sealed plastic tubes previously identified with a code corresponding to the name of
the patient. Pro-inflammatory/pleiotropic cytokines, which are found during inflammatory
processes at cellular level will be assess. The fluorescence based multiplex protein
quantification system (BioPlex, BioRad, Hercules CA, USA) will be used to measure the
following eight cytokines: GM-CSF, IFN-gamma, IL-2, IL-4, IL-6, IL-8, IL-10 and TNF-α.
Ethical Considerations
The patients will be asked to review and sign a written consent form. Only individuals
involved in this study will have access to the data collected during the study. The records
for each patient will be assigned with a unique number and will be stored by the principal
investigator at her desk within the clinic premises. The master sheet linking the patient
identifiers to the unique number will be stored in a safe in the clinic administrative
office. In case of possible continuation of line of investigation, the data could be
compared with new data (introduction of air abrasive). The master sheet and patient records
will be shredded at the end of 4-5 years. To thank them for their participation in the study
they will receive a free maintenance appointment at the end of the study (12 months).
Relevance of the study
This study is relevant because there is currently no long term in vivo studies that
determine the effectiveness of peri-implant maintenance and also the possible differences
and/or similar outcomes between curettes and ultrasonics in the peri-implant maintenance
protocol.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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