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Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis in Peri-implant Mucositis (Mucosite prob)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04187222
Recruitment Status : Completed
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Michel Reis Messora, University of Sao Paulo

Study Description
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Brief Summary:
Peri-implant disease is an inflammatory process of bacterial etiology that can affect the tissues around the implants and can be classified as peri-implant mucositis or peri-implantitis. The confirmation of the action of probiotics against microorganisms that cause peri-implant diseases can represent a great advance in the treatment of these diseases that affect a large part of the population, and may even reduce or prevent the use of antibiotics, reducing the risk of implant loss and, consequently, greater damage to the oral and systemic health of individuals. The purpose of this study was to evaluate the action of probiotics on the peri-implant health of total edentulous patients using Branemark protocol prosthetic rehabilitations. For this, 38 patients were selected, without systemic alterations and non-smokers. Clinical monitoring was performed at baseline (pre-intervention period) as well as at 12 and 24 weeks after study initiation. The following parameters were evaluated: modified gingival index (MGI), modified plaque index (MPI), probing depth (PD) and probing bleeding (PB). Data were subjected to statistical analysis at a significance level of 5%. There was an increase in sites with IGM 0 in the test group at 12 and 24 weeks. The test group presented more sites with IGM 0 than the control. IPM 0 sites increased in the control group at 12 and 24 weeks in the control group. PD decreases in a test and control group. Finally, the test group had lower PB rates. Thus, the probiotic used demonstrated ability to contribute to the improvement of peri-implant health of the patients analyzed.

Condition or disease Intervention/treatment Phase
Mucositis Oral Other: Mechanical debridements Biological: Bifidobacterium animalis subsp. lactis Phase 3

Detailed Description:

Clinical monitoring. MGI (0: no bleeding when a periodontal tube is passed along the mucosal margin adjacent to the implant; 1: visible isolated bleeding points; 2: blood forms a confluent red line at the mucosal margin and 3: profuse bleeding) and the MPI (0: no plaque; 1: plaque recognized only by probing through the smooth marginal surface of the implant; 2: plaque can be seen with the naked eye; 3: abundance of alba matter). PD was determined using a soft plastic periodontal probe for torque-controlled implants at 0.15 N / cm. Three buccal and three lingual reference points for each implant were used to calculate the mean probing depth in millimeters for each implant. PB was dichotomously evaluated: the presence of bleeding was considered positive when it occurred within 20 seconds after insertion of the probe to measure PD. The height of the keratinized mucosa present around each implant was also measured.

All clinical parameters described above were recorded at baseline (pre-intervention period) as well as at 12 and 24 weeks after study initiation.

Treatment of peri-implant mucositis and maintenance care. Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curves and polishing using a rubber bowl and polishing paste. In the Test Group the treatment session was completed by a professional topical application around the carboxymethylcellulose gel implants containing 109 colony (CFU) forming units of B. lactis HN019. The gel was applied sub and supragingivally. The patients then received commercial capsules containing the same bacteria and were instructed to dissolve the capsule contents in 20 mL of water and rinse for 30 to 60 seconds, followed by swallowing twice a day for 12 weeks. The control group received the same oral hygiene instructions, mechanical debridement and was treated with gel and placebo tablets. At 3 months postoperatively, the same local mechanical and chemical treatment was repeated for the Test and Control groups.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Treatment of peri-implant mucositis and maintenance care Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curves and polishing using a rubber bowl and polishing paste. In the Test Group the treatment session was completed by a professional topical application around the carboxymethylcellulose gel implants containing 109 CFLs of B. lactis HN019. The gel was applied sub and supragingivally. The patients then received commercial capsules containing the same bacteria and were instructed to dissolve the capsule contents in 20 mL of water and rinse for 30 to 60 seconds, followed by swallowing twice a day for 12 weeks. The control group received the same oral hygiene instructions, mechanical debridement and was treated with gel and placebo tablets. At 3 months postoperatively, the same local mechanical and chemical treatment was repeated for the Test and Control groups.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis as Adjunctive Therapy in Non-surgical Treatment of Periimplant Mucositis: a Randomized Controlled Trial
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : November 15, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Test Group
Mechanical treatment + Bifidobacterium animalis subsp. lactis
 Other: Mechanical debridements
Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curette and polishing using a rubber bowl and polishing paste.

Biological: Bifidobacterium animalis subsp. lactis
Capsules containing Bifidobacterium animalis subsp. lactis were chubby and subsequently ingested twice a day for 12 weeks.
Placebo Comparator: Control Group
Mechanical treatment + Placebo
 Other: Mechanical debridements
Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curette and polishing using a rubber bowl and polishing paste.


Outcome Measures
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Primary Outcome Measures :
  1. Bleeding the probing. [ Time Frame: Baseline. ]
  2. Bleeding the probing. [ Time Frame: 12 weeks. ]
  3. Bleeding the probing. [ Time Frame: 24 weeks. ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • completely edentulous lower or upper dental arch undergoing rehabilitation with dental implants;
  • prosthetic restoration in function for at least 6 months;
  • healthy individuals with no known systemic changes;
  • non smokers.

Exclusion Criteria:

  • patients who have received any type of local or systemic oral cavity decontamination treatment within the last 3 months or periodontal treatment within the last 6 months; uncontrolled periodontal disease;
  • patients with systemic disorders capable of influencing treatment outcomes;
  • smokers;
  • lack of informed consent to participate in the study;
  • presence of bone loss greater than 2 mm in dental implants.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187222


Locations
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Brazil
School of Dentistry of Ribeirao Preto - University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michel Reis Messora, Associate professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04187222    
Other Study ID Numbers: 82840117.4.0000.5419
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: November 2019

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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
Keywords provided by Michel Reis Messora, University of Sao Paulo:
Dental implants
Mucositis
Probiotics
Bleeding on probing
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases