The Effects of Non-surgical Periodontal Therapy in Patients Indicated for Bariatric Surgery
Condition: Periodontitis; Obesity, Morbid; Bariatric Surgery Candidate
MeSH terms: Periodontitis; Obesity, Morbid
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Scaling and root planing; Probiotic lozenges
Intervention type(s): Procedure; Device
Intervention description(s): Patients with periodontitis in the test group will be treated by conventional non-surgical root debridement and in the control group by low-intensive supragingival plaque removal with mechanical brush and professional tooth paste only.; Patients with gingivitis in the test group 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 by low-intensive supragingival plaque removal, as a placebo treatment, and placebo probiotics lozenges.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment