- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04653714
The Effects of Non-surgical Periodontal Therapy in Patients Indicated for Bariatric Surgery
The Effects of Non-surgical Periodontal Therapy in Patients Indicated for Bariatric Surgery on the Periodontal and Systemic Inflammation Parameters: a Randomized Double Blinded Controlled Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ljubljana, Slovenia, 1000
- University Medical Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥18 years patients undergoing BS (morbidly obese patients (obesity class III) and obese patients (class II and I) with obesity related comorbidities: diabetes mellites type II, Hypertension, hyperlipidaemia, obstructive sleep apnea, articular pain, polycystic ovary syndrome) from Department of Abdominal Surgery, University Medical Centre Ljubljana.
- ≥ 16 teeth present
- Diagnoses with periodontitis or gingivitis
- Singed consent
Exclusion Criteria:
- Antibiotic and periodontal therapy in previous 6 months
- The need of prophylactic antibiotic therapy
- Pregnant women, lactation
- Cancer and other serious chronic diseases (excluding metabolic syndrome) with known influence on periodontal health
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Full mouth debridement
Supragingival plaque/calculus removal and scaling and root planing
|
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.
|
Sham Comparator: Supragingival plaque/calculus removal
Supragingival plaque and calculus removal
|
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.
|
Experimental: Probiotic lozenges
Daily usage of probiotic lozenges
|
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.
|
Active Comparator: Placebo lozenges
Daily usage of placebo lozenges
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Bleeding on Probing (BOP) Sites
Time Frame: at 7 months after treatment
|
Percentage of probing sites that bleed will be calcuated from fill mouth record
|
at 7 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing Pocket Depth (PPD) change
Time Frame: at 7 months post treatment
|
Difference between the baseline and 7 months post-treatment PPD
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at 7 months post treatment
|
Clinical Attachment Level (CAL) change
Time Frame: at 7 months post treatment
|
Difference between the baseline and 7 months post-treatment CAL
|
at 7 months post treatment
|
C-reactive protein (CRP)
Time Frame: at 7 months post treatment
|
CRP levels in the blood increase when there is a condition causing inflammation somewhere in the body.
|
at 7 months post treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral Health Impact Profile (OHIP) -14 questionnaire
Time Frame: at 7 months post treatment
|
OHIP is a standard oral health realted quality of life assessment tool
|
at 7 months post treatment
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULjubljana
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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