NCT04653714

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

Completed NA Last updated 17 December 2021

What this trial tests

NA trial testing Scaling and root planing in Periodontitis in 70 participants. Completed in 30 November 2021.

Timeline

1 June 2020

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	University of Ljubljana
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	70
Start date	1 June 2020
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	1 location across Slovenia

Drugs / interventions tested

• Scaling and root planing
• Probiotic lozenges — full drug profile →

Conditions studied

• Periodontitis — all drugs for Periodontitis →
• Obesity, Morbid — all drugs for Obesity, Morbid →
• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →

Sponsor

University of Ljubljana

Who can join

Adults 18 to 65, any sex, with Periodontitis or Obesity, Morbid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in therapeutic probiotics: insights from human trials.
   Cho M-Y, Eom J-H, Choi E-M, Yang S-J, et al · · 2025 · cited 17× · PMID 40261032 · DOI 10.1128/cmr.00240-24
2. Periodontal and systemic health of morbidly obese patients eligible for bariatric surgery: a cross-sectional study.
   Čolak D, Cmok Kučič A, Pintar T, Gašpirc B, et al · · 2022 · cited 4× · PMID 35562737 · DOI 10.1186/s12903-022-02207-0
3. Periodontal Therapy in Bariatric Surgery Patients with Periodontitis: Randomized Control Clinical Trial.
   Čolak D, Cmok Kučič A, Pintar T, Gašperšič R. · · 2022 · cited 2× · PMID 36431314 · DOI 10.3390/jcm11226837