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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069611
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : June 1, 2020
Sponsor:
Collaborator:
Sunstar, Inc.
Information provided by (Responsible Party):
Universidad Complutense de Madrid

Tracking Information
First Submitted Date  ICMJE August 23, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date June 1, 2020
Actual Study Start Date  ICMJE January 30, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2019)
Probing Pocket Depth (PPD) [ Time Frame: Baseline, 3 and 6 months ]
Change in Probing Pocket Depth (PPD)
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
Probing Pocket Depth (PPD) [ Time Frame: 6 months ]
Change in Probing Pocket Depth (PPD)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2019)
  • Residual Pockets (PPD>4m ) [ Time Frame: Baseline, 3 and 6 months ]
    Percentage of residual pockets
  • Bleeding on Probing (BOP) [ Time Frame: Baseline, 3 and 6 months ]
    Changes in bleeding on probing
  • Patient Satisfaction [ Time Frame: Baseline, 3 and 6 months ]
    Patient satisfaction as determined by visual analogue scales (min:0; max:10; 0 indicates worst patient satisfaction, while 10 indicates maximum satisfaction)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
  • Residual Pockets (PPD>4m ) [ Time Frame: 6 months ]
    Percentage of residual pockets
  • Bleeding on Probing (BOP) [ Time Frame: 6 months ]
    Changes in bleeding on probing
  • Patient Satisfaction [ Time Frame: 6 months ]
    Patient satisfaction as determined by visual analogue scales
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non Surgical Therapy of Periodontitis in Diabetes Patients: the Adjunctive Use of Probiotics
Official Title  ICMJE Non Surgical Therapy of Periodontitis in Diabetes Patients: the Adjunctive Use of Probiotics
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.
Detailed Description

Diabetes patients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain). Patients fulfilling the required criteria will be invited to participate in the study, will be informed on the study purposes, and will be invited to sign and IRB approved informed consent.The study will be designed as a doubled-blind, placebo controlled, parallel, randomized clinical trial with a 6-month follow-up. The patients will be examined for clinical parameters and microbiological sampling, and randomised into two different groups.The following study visits will be scheduled:

Screening visit Potential patient eligibility will be based on the inclusion/exclusion criteria already presented. Patients will be informed about their periodontal condition and treatment needs. Patients willing to participate in the study will be given additional information about the study and upon signing a consent form, they will be appointed for the graduate clinic of Periodontology.

Baseline visit Patients will undergo a comprehensive oral and periodontal examination. Full-mouth clinical measurements of PPD and clinical attachment level (CAL) will be taken at 6 sites per tooth, excluding third molars, and will be rounded to the nearest millimetre using a UNC-15 probe (Hu-Friedy, Chicago, IL, USA). Panoramic radiographs and/or full-mouth periapical radiographs will also be taken, as standard procedures of the postgraduate clinic. Microbiological samples will be taken. The patient smoking history will be recorded and participants will be categorized as: current smokers (those who smoked at least one cigarette per day); never smokers (those who had never smoked in their life); and former smokers (those who had stopped smoking at least 1 year previously). Other relevant aspects of the medical history will be also collected, including the evaluation of the glycated haemoglobin (HbA1c) levels by means of standard laboratory procedures.

Treatment visits Subjects will receive non-surgical periodontal therapy in the form of full-mouth SRP, in two consecutive days, in combination with 0.12% chlorhexidine (Gum Chlorhexidine Oral Rinse, Etoy, Switzerland) application by means of rinsing prior to and at the end of each SRP session. All patients will receive standardized oral hygiene instructions, including the use of a manual toothbrush (GUM® Activital Toothbrush), and interdental brushers (GUM® Trav-ler and GUM® Soft Picks). Instructions will be periodically reinforced.

Immediately after oral hygiene instructions, patients will be randomly allocated to the test or control groups. One investigator before patient recruitment will generate the randomization sequence by blocks. Random assignment into two groups will be carried out with the use of a computer program. Containers will be designed to maintain examiner blinding. The patients will be randomly allocated, with the help of a computer, in two groups:

  • Test group: 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).
  • Placebo group: Subjects assigned to the placebo group will take lozenges exactly like the test ones but without bacteria.

Follow up visits after 3 and 6 months Follow up visits will have the objective to monitor the clinical and microbiological changes in the periodontal condition and to evaluate the bacterial re-colonization pattern in the subgingival niche. This phase will include two recall visits, at which clinical measurements will be repeated and microbiological samples will be collected. Oral hygiene will be reinforced. Glycated haemoglobin levels will be assessed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Periodontitis
Intervention  ICMJE
  • Other: Probiotic
    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).
  • Other: Placebo
    Subjects assigned to the placebo group will take lozenges exactly like the test ones but without bacteria.
  • Procedure: Scaling and root planing
    Mechanical debridement with US and curettes of hard and soft plaque deposits
    Other Name: SRP
Study Arms  ICMJE
  • Experimental: Test Group
    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).
    Interventions:
    • Other: Probiotic
    • Procedure: Scaling and root planing
  • Placebo Comparator: Control Group
    Subjects assigned to the placebo group will receive scaling and root planing, and will take lozenges exactly like the test ones but without bacteria.
    Interventions:
    • Other: Placebo
    • Procedure: Scaling and root planing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Eduardo Montero, MSc +34 630138408 eduardomonterosolis@ucm.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04069611
Other Study ID Numbers  ICMJE 19/101-R_X
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universidad Complutense de Madrid
Study Sponsor  ICMJE Universidad Complutense de Madrid
Collaborators  ICMJE Sunstar, Inc.
Investigators  ICMJE Not Provided
PRS Account Universidad Complutense de Madrid
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP