Non Surgical Therapy of Periodontitis in Diabetes Patients: the Adjunctive Use of Probiotics

NCT04069611 | Unknown

• 1 other identifier: 19/101-R_X
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical and microbiological performance of a probiotic formulation (Sunstar GUM Periobalance) as adjunctive to non-surgical periodontal therapy in patients with diabetes. The null hypothesis is that the adjunctive use of this probiotic formulation would not have any additional benefit over scaling and root planning in the number of residual pockets or in the microbiological impact of the treatment. Conversely, the alternative hypothesis is that the adjunctive use of this formulation would improve the clinical results of non-surgical periodontal therapy when compared to scaling and root planing alone, through a modification of the subgingival biofilm composition.

Conditions

Diabetes; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Probing Pocket Depth (PPD)

  Change in Probing Pocket Depth (PPD)

  Baseline, 3 and 6 months

Secondary Outcomes (3)

• Residual Pockets (PPD>4m )

  Baseline, 3 and 6 months

• Bleeding on Probing (BOP)

  Baseline, 3 and 6 months

• Patient Satisfaction

  Baseline, 3 and 6 months

Study Arms (2)

Test Group

EXPERIMENTAL

Subjects in the test group will receive scaling and root planing, plus the take two probiotic lozenges per day for 3 months (one in the morning and one in the afternoon after brushing their teeth), starting after the last session of SRP. Lozenges will contain L. reuteri (2 x 108 colony forming units/tablet of strains ATCC 55730 and ATCC PTA 5289; Sunstar GUM Periobalance).

Other: Probiotic; Procedure: Scaling and root planing

Control Group

PLACEBO COMPARATOR

Subjects assigned to the placebo group will receive scaling and root planing, and will take lozenges exactly like the test ones but without bacteria.

Other: Placebo; Procedure: Scaling and root planing

Interventions

Probiotic OTHER

Subjects in the test group will take two probiotic lozenges per day for 3 months (one in the morning and one in the afternoon after brushing their teeth), starting after the last session of SRP. Lozenges will contain L. reuteri (2 x 108 colony forming units/tablet of strains ATCC 55730 and ATCC PTA 5289; Sunstar GUM Periobalance).

Test Group

Placebo OTHER

Subjects assigned to the placebo group will take lozenges exactly like the test ones but without bacteria.

Control Group

Scaling and root planing PROCEDURE

Mechanical debridement with US and curettes of hard and soft plaque deposits

Also known as: SRP

Control Group; Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosed diabetes, for at least 1 year.
• Presence of a minimum of 18 teeth.
• Untreated stages II and III periodontitis with radiographic evidence of generalized alveolar bone loss higher than 30%, and presence of at least one pocket with probing pocket depth (PPD) higher than 5 mm per quadrant with bleeding on probing (BOP).

You may not qualify if:

• Subgingival instrumentation within 12 months before baseline examination.
• Use of antibiotics in the three months prior to the study.
• Use of other probiotic products in the month prior the study.
• Systemic diseases that could affect the course of periodontitis or its treatment such as immunological disorders, excluding diabetes.
• Ongoing drug therapy influencing the evaluated clinical parameters (non-steroid inflammatory drugs, etc.).
• Compromised medical conditions requiring prophylactic antibiotic therapy (e.g. patients with valvular prostheses, patients with previous history of bacterial endocarditis, congenital heart diseases like shunts or heart transplant recipients who developed valvular heart disease)
• Pregnancy.
• Stage IV periodontitis, or acute periodontal conditions.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Sunstar, Inc.: collaborator

Study Sites (1)

Faculty of Odontology

Madrid, 28040, Spain

RECRUITING

Related Publications (1)

• Bujaldon R, Montero E, Gamonal JD, Abuelo A, Marin MJ, Iniesta M, Sanz M, Herrera D. Use of the Probiotic Limosilactobacillus reuteri as an Adjunct to Subgingival Instrumentation in the Treatment of Periodontitis Patients With Diabetes: A Randomised Clinical Trial. J Clin Periodontol. 2026 Jan;53(1):26-36. doi: 10.1111/jcpe.70035. Epub 2025 Sep 17.

  PMID: 40958659 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Periodontitis

Interventions

Probiotics; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Central Study Contacts

Eduardo Montero, MSc

CONTACT

+34 630138408; eduardomonterosolis@ucm.es

Study Design

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

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: January 30, 2020
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)