Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis in Peri-implant Mucositis (Mucosite prob)
Primary Purpose
Mucositis Oral
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Mechanical debridements
Bifidobacterium animalis subsp. lactis
Sponsored by
About this trial
This is an interventional prevention trial for Mucositis Oral focused on measuring Dental implants, Mucositis, Probiotics, Bleeding on probing
Eligibility 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.
Sites / Locations
- School of Dentistry of Ribeirao Preto - University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test Group
Control Group
Arm Description
Mechanical treatment + Bifidobacterium animalis subsp. lactis
Mechanical treatment + Placebo
Outcomes
Primary Outcome Measures
Bleeding the probing.
Bleeding the probing.
Bleeding the probing.
Secondary Outcome Measures
Full Information
NCT ID
NCT04187222
First Posted
November 25, 2019
Last Updated
December 4, 2019
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04187222
Brief Title
Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis in Peri-implant Mucositis
Acronym
Mucosite prob
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral
Keywords
Dental implants, Mucositis, Probiotics, Bleeding on probing
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Experimental
Arm Description
Mechanical treatment + Bifidobacterium animalis subsp. lactis
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Mechanical treatment + Placebo
Intervention Type
Other
Intervention Name(s)
Mechanical debridements
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Bifidobacterium animalis subsp. lactis
Intervention Description
Capsules containing Bifidobacterium animalis subsp. lactis were chubby and subsequently ingested twice a day for 12 weeks.
Primary Outcome Measure Information:
Title
Bleeding the probing.
Time Frame
Baseline.
Title
Bleeding the probing.
Time Frame
12 weeks.
Title
Bleeding the probing.
Time Frame
24 weeks.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
School of Dentistry of Ribeirao Preto - University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-904
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
28032908
Citation
Mongardini C, Pilloni A, Farina R, Di Tanna G, Zeza B. Adjunctive efficacy of probiotics in the treatment of experimental peri-implant mucositis with mechanical and photodynamic therapy: a randomized, cross-over clinical trial. J Clin Periodontol. 2017 Apr;44(4):410-417. doi: 10.1111/jcpe.12689. Epub 2017 Feb 18.
Results Reference
background
PubMed Identifier
25953193
Citation
Hallstrom H, Lindgren S, Widen C, Renvert S, Twetman S. Probiotic supplements and debridement of peri-implant mucositis: a randomized controlled trial. Acta Odontol Scand. 2016;74(1):60-6. doi: 10.3109/00016357.2015.1040065. Epub 2015 May 8.
Results Reference
background
PubMed Identifier
25712760
Citation
Flichy-Fernandez AJ, Ata-Ali J, Alegre-Domingo T, Candel-Marti E, Ata-Ali F, Palacio JR, Penarrocha-Diago M. The effect of orally administered probiotic Lactobacillus reuteri-containing tablets in peri-implant mucositis: a double-blind randomized controlled trial. J Periodontal Res. 2015 Dec;50(6):775-85. doi: 10.1111/jre.12264. Epub 2015 Feb 25.
Results Reference
background
PubMed Identifier
35634695
Citation
Santana SI, Silva PHF, Salvador SL, Casarin RCV, Furlaneto FAC, Messora MR. Adjuvant use of multispecies probiotic in the treatment of peri-implant mucositis: A randomized controlled trial. J Clin Periodontol. 2022 Aug;49(8):828-839. doi: 10.1111/jcpe.13663. Epub 2022 Jun 10.
Results Reference
derived
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Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis in Peri-implant Mucositis
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