Use of Probiotics in Oral Health of Patients With Dental Implants

Mucositis Clinical Trial

Official title:

THE EFFECT OF ORALLY ADMINISTERED PROBIOTIC LACTOBACILLUS REUTERI-CONTAINING TABLETS IN PERI-IMPLANT MUCOSITIS: A RANDOMIZED CLINICAL TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974596
• Other study ID #: Probiotics
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2013
• Last updated: October 27, 2013
• Start date: January 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2013
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study was evaluate the effects of the oral probiotic Lactobacillus reuteri Prodentis upon the peri-implant health of edentulous patients with dental implants and peri-implant mucositis, establishing comparisons versus implants without peri-implant disease. The hypothesis of the study is that using these probiotics are going to improve the periimplant health.

Description:

A double-blind, placebo-controlled, prospective cross-over study was made. All the patients were edentulous and were divided into two groups: A) with no peri-implant disease; B) with peri-implant mucositis affecting one or more implants. Patients with peri-implantitis were excluded. All patients in both groups initially received the oral probiotic Lactobacillus reuteri Prodentis, followed by placebo. Only the supervisor of the study knew this information; clinical examiner and patients were blind. Were studied: crevicular fluid volume, modified plaque index, probing depth, modified gingival index, and concentrations of interleukin 1β, interleukin 6 and interleukin 8, and Bacterial load.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2010
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Totally edentulous patients subjected to dental implant rehabilitation in one or both arches

• Prosthetic restoration in function for at least 24 months

• Healthy individuals without known disease

Exclusion Criteria:

• Patients receiving any kind of local or systemic decontamination treatment of the oral cavity (e.g., antibiotics or rinses) in the last 3 months, or periodontal treatment in the last 6 months

• Uncontrolled periodontal disease

• Patients with immune deficiencies, diabetes, rheumatoid disease, head and neck radiotherapy, bisphosphonate treatment, chemotherapy or anticoagulation

• Patients with dental implants presenting intraoral exposure of the rough portion of any implant

• Smokers

• Incomplete protocols due to a lack of patient cooperation: a) failure to follow the treatment instructions; b) failure to report to the visit after one month of follow-up

• Failure to provide informed consent to participation the study

• Patients presenting at least one implant with peri-implantitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucositis

Intervention

Dietary Supplement:
• Probiotic tablets of Lactobacillus reuteri

• Placebo tablets

Locations

Country	Name	City	State
Spain	Department of Oral Surgery, University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evidence of reduction of Total Bacterial Load studied	Where evaluate Aggregatibacter and red complex of socransky	28 days using probiotic tablets/day	Yes
Primary	Evidence in reduction of plaque index	The Mombelli clasification was used to evaluate the reduction of bacterial plaque. 0: No bacterial plaque; 1: presence of bacterial plaque but not visually; 2: 1/3 part of the implant with bacterial plaque; 3: 2/3 parts or more of the implant with bacterial plaque	28 days using one probiotic tablet/day	Yes
Secondary	Evidence in reduction of bleeding around implants	The Mombelli classification was used to evaluate the reduction of bleeding around implants: 0: no bleeding; 1: a point of bleeding; 2)a line of bleeding; 3: much bleeding	28 days using probiotic tablet/day	Yes
Secondary	Evidence in reduction of probing depth	Was measured in reduction of millimeters of the depth of the implant with a millimeter probe.	28 days using one probiotic tablet/day	Yes
Secondary	Evidence in reduction Interleukin 1ß concentration	concentration measured in picograms/milliliter (pg/ml)	28 days using one probiotic tablet/day	Yes
Secondary	Evidence in reduction Interleukin 6 concentration	concentration measured in picograms/milliliter (pg/ml)	28 days using one probiotic tablet/day	Yes
Secondary	Evidence in reduction Interleukin 8 concentration	concentration measured in picograms/milliliter (pg/ml)	28 days using one probiotic tablet/day	Yes