Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04653714 |
| Other study ID # |
ULjubljana |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
University of Ljubljana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
By World Health Organization (WHO) definition overweight (body mass index (BMI) >24.9) and
obesity (BMI >29.9) are defined as abnormal or excessive fat accumulation with many possible
impacts on individual's health. Association between obesity and associated metabolic syndrome
(obesity, hypertension, diabetes mellitus type 2 and dyslipidemia) and oral health has become
clear from several studies that proved increased odds of obese patients for developing of
caries-related pathologies and periodontal disease. Periodontal disease, a major cause of
tooth loss in adults, is an inflammatory disease of periodontal tissue that is initiated by
dental plaque bacteria and is modulated by the inflammatory-immune host response factors.
Relation between periodontal disease and obesity is bi-directional, through sharing of
several proposed local and systemic pathogenesis mechanisms. For treatment of obesity,
bariatric surgery (BS) procedures are methods of choice, when other less invasive options
fail. They are safe, cost-effective, improve overall health and increase life expectancy.
There are several types of BS interventions and most commonly performed BS is laparoscopic
sleeve gastrectomy and with second most often, Roux-en-Y gastric bypass. Studies on influence
of BS on periodontal health showed diverse results, with some showing no effect, while others
demonstrated an increase in the prevalence of periodontitis as well as a further
deterioration of periodontal tissues after BS procedure. However, studies on the prevalence
of gingivitis, a reversible plaque-induced inflammation of gingiva, and its progression to
periodontitis in BS patients is lacking. Furthermore, dental and periodontal status are not
routinely evaluated in patients before or after BS. To the best of our knowledge studies on
the effect of periodontal therapy before BS are lacking.
Description:
Obesity is becoming one of the mayor worldwide health problems due to increasing prevalence.
In the Slovenia 63.4% of population are overweight (24.99 kg/m² < BMI < 29.99 kg/m²) and
28.6% are obese (BMI > 30 kg/m²). Obese patients have a predisposing factor of many chronic
diseases including periodontal disease (PD). PD is an inflammatory disease of tooth
supporting tissues that is initiated by dental plaque bacteria and modulated by the
inflammatory-immune host response factors. Some of the causes for periodontitis in obese
individuals are hyperinflammatory response, different fat metabolism and higher degree of
insulin resistance. On the other hand, periodontitis is thought to have a negative effect on
some obesity related comorbidities by rising systemic inflammation, increasing insulin
resistance, lipid profile and endothelial function.
Several methods have been proposed for weight loss like dieting, physical exercise,
pharmacologic treatment and surgical intervention. Bariatric surgery (BS) has been shown to
be an effective weight loss strategy and is proposed as a frontline therapy for adult
patients with severe obesity. The outcomes of bariatric surgery show decreased levels of
pro-inflammatory markers such as Tumour Necrosis Factor alpha (TNF-α), interleukine-6 (IL6)
and C-reactive protein (CRP) and therefore improvement of general inflammation status.
Research papers observing association between BS and PD mostly advocate worsening of
periodontal status and oral health as a complication of BS. Observational studies have shown
that obese patients undergoing BS procedures have a high prevalence of periodontal disease
and even though metabolic parameters are advancing to normal values after BS, inflammatory
response to plaque bacteria in the gingiva is increased, with possible additional destruction
of periodontal tissues. The reasons for high prevalence as well as deterioration after BS
procedure is not completely understood. To the best of our knowledge, there are no
interventional studies with non-surgical periodontal therapy that aim to lower PD progression
after BS.
The aim is to investigate the influence of non-surgical periodontal therapy 1 month before BS
in patients diagnosed with periodontitis and gingivitis on the level of reduction in
local/systemic inflammatory and periodontal parameters. The second aim is to test whether
implemented periodontal therapy has some impact on metabolic parameters and comorbidities of
obesity after BS.
Participants will be selected in a randomized, interventional, blinded (examiner),
prospective study, from 70 obese patients indicated for BS with criteria obesity class III
(ITM over 40 kg/m2) and class I and II with obesity if related disease are present: diabetes
mellitus type II, Hypertension, hyperlipidaemia, obstructive sleep apnea, articular pain,
polycystic ovary syndrome. Patients will be recruited from Department of Abdominal Surgery,
University Medical Centre Ljubljana, were BS procedure will be performed, and pre- and
post-operative systemic and obesity related data will be collected. All relevant medical data
will be taken from the records.
All the oral health intervention will be held at the Department for Oral Diseases and
Periodontology, Dental Clinic, University Medical Centre Ljubljana. At the first visit
general health, socioeconomic, dental information will be recorded by a questionnaire before
surgical procedure. At the same time patients will undergo periodontal examination (number of
the teeth, prosthetic rehabilitation status, full mouth plaque score (FMPS), full mouth
bleeding score (FMBS), periodontal pocket depth (PPD), clinical attachment level (CAL),
bleeding on probing (BOP), recession, furcation involvement, teeth mobility.
After oral examination, two study groups will be established (gingivitis n=30; and
periodontitis patients n=40).
One month before scheduled BS periodontal therapy will be performed in all patients regarding
their periodontal diagnosis (e.g. periodontitis or gingivitis) and previously predetermined
randomisation to (test and control group) All included patients will be properly instructed
and motivated for oral hygiene and fill out OHIP-14 questionnaire.
Patients with gingivitis in the test group (n=15) will be treated with supragingival
debridement and with probiotic lozenges with strains of Lactobacillus brevis and
Lactobacillus plantarum once a day for 3 months and in the control group (n=15) by
low-intensive supragingival plaque removal, as a placebo treatment, and placebo probiotics
lozenges.
Patients with periodontitis in the test group (n=20) will be treated by conventional
non-surgical root debridement and in the control group (n=20), as a placebo treatment, by
low-intensive supragingival plaque removal with mechanical brush and professional tooth paste
only.
