Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis in Peri-implant Mucositis

NCT04187222 | Completed Phase 3 DMC

• 1 other identifier: 82840117.4.0000.5419
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucositis Oral

Keywords

Dental implants; Mucositis; Probiotics; Bleeding on probing

Outcome Measures

Primary Outcomes (3)

• Bleeding the probing.

  Baseline.

• Bleeding the probing.

  12 weeks.

• Bleeding the probing.

  24 weeks.

Study Arms (2)

Test Group

EXPERIMENTAL

Mechanical treatment + Bifidobacterium animalis subsp. lactis

Other: Mechanical debridements; Biological: Bifidobacterium animalis subsp. lactis

Control Group

PLACEBO COMPARATOR

Mechanical treatment + Placebo

Other: Mechanical debridements

Interventions

Mechanical debridements OTHER

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.

Control Group; Test Group

Bifidobacterium animalis subsp. lactis BIOLOGICAL

Capsules containing Bifidobacterium animalis subsp. lactis were chubby and subsequently ingested twice a day for 12 weeks.

Test Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry of Ribeirao Preto - University of São Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (4)

• 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.

  PMID: 28032908 BACKGROUND

• 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.

  PMID: 25953193 BACKGROUND

• 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.

  PMID: 25712760 BACKGROUND

• 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.

  PMID: 35634695 DERIVED

MeSH Terms

Conditions

Stomatitis; Mucositis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 5, 2019
• Study Start: July 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: November 15, 2019
• Last Updated: December 5, 2019

Record last verified: 2019-11

Locations

BR (1)