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

NCT04653714 | Completed

• 1 other identifier: ULjubljana
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis; Obesity, Morbid; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Percentage of Bleeding on Probing (BOP) Sites

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

  at 7 months after treatment

Secondary Outcomes (3)

• Probing Pocket Depth (PPD) change

  at 7 months post treatment

• Clinical Attachment Level (CAL) change

  at 7 months post treatment

• C-reactive protein (CRP)

  at 7 months post treatment

Other Outcomes (1)

• Oral Health Impact Profile (OHIP) -14 questionnaire

  at 7 months post treatment

Study Arms (4)

Full mouth debridement

EXPERIMENTAL

Supragingival plaque/calculus removal and scaling and root planing

Procedure: Scaling and root planing

Supragingival plaque/calculus removal

SHAM COMPARATOR

Supragingival plaque and calculus removal

Procedure: Scaling and root planing

Probiotic lozenges

EXPERIMENTAL

Daily usage of probiotic lozenges

Device: Probiotic lozenges

Placebo lozenges

ACTIVE COMPARATOR

Daily usage of placebo lozenges

Device: Probiotic lozenges

Interventions

Scaling and root planing PROCEDURE

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.

Full mouth debridement; Supragingival plaque/calculus removal

Probiotic lozenges DEVICE

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.

Placebo lozenges; Probiotic lozenges

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

University Medical Centre

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 35562737 DERIVED

MeSH Terms

Conditions

Periodontitis; Obesity, Morbid

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: December 4, 2020
• Study Start: June 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)