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PeriodontitisNCT04653714

The Effects of Non-surgical Periodontal Therapy in Patients Indicated for Bariatric Surgery

A study testing Scaling and root planing and Probiotic lozenges in people with Periodontitis and Obesity, Morbid, run by University of Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Scaling and root planing and Probiotic lozenges
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteSlovenia
Study dates
1 Jun 2020to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site
  • University Medical Centre

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: 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

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.

Read the 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.

Being tested
Scaling and root planing, Probiotic lozenges
Medical subject headings
Periodontitis, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scaling and root planingProcedure or surgery

    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.

  • Probiotic lozengesDevice

    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.

Study groups in NCT04653714
Study groupRoleWhat they receive
Full mouth debridementExperimentalSupragingival plaque/calculus removal and scaling and root planing
Receives: Procedure: Scaling and root planing
Supragingival plaque/calculus removalSham comparatorSupragingival plaque and calculus removal
Receives: Procedure: Scaling and root planing
Probiotic lozengesExperimentalDaily usage of probiotic lozenges
Receives: Device: Probiotic lozenges
Placebo lozengesActive comparatorDaily usage of placebo lozenges
Receives: Device: Probiotic lozenges

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Bleeding on Probing (BOP) Sites

    Percentage of probing sites that bleed will be calcuated from fill mouth record

    Measured: at 7 months after treatment

Secondary outcomes (3)
  1. Probing Pocket Depth (PPD) change

    Difference between the baseline and 7 months post-treatment PPD

    Measured: at 7 months post treatment

  2. Clinical Attachment Level (CAL) change

    Difference between the baseline and 7 months post-treatment CAL

    Measured: at 7 months post treatment

  3. C-reactive protein (CRP)

    CRP levels in the blood increase when there is a condition causing inflammation somewhere in the body.

    Measured: at 7 months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2020
  2. Study start1 Jun 2020
  3. Primary completion30 Nov 2021
  4. Study completion30 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04653714
Sponsor's protocol ID
ULjubljana
Status last verified
Dec 2021
First submitted
23 Oct 2020
Last updated
17 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Colak D, Cmok Kucic A, Pintar T, Gaspirc B, Gaspersic R. Periodontal and systemic health of morbidly obese patients eligible for bariatric surgery: a cross-sectional study. BMC Oral Health. 2022 May 13;22(1):174. doi: 10.1186/s12903-022-02207-0.

    PubMed 35562737

Questions about this trial

What is this clinical trial studying?

A study testing Scaling and root planing and Probiotic lozenges in people with Periodontitis and Obesity, Morbid, run by University of Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Bleeding on Probing (BOP) Sites (time frame: at 7 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04653714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.

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