Clinical trial NCT05758103: Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis
Official title: Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis in Total Rehabilitation: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: probiotic
Limosilactobacillus reuteri
dental implant
peri-implant mucositis
total rehabilitation
mechanical therapy
nonsurgical treatment
Lead sponsor: Malo Clinic
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-group parallel design
Primary purpose: TREATMENT

Brief summary: Mechanical debridement is the traditional method for the treatment of peri-implant mucositis and its success depends on the patient's correct oral hygiene. It is believed that probiotics may help by their ability to modulate the oral biofilm, resulting in anti-inflammatory and anti-bacterial plaque action. The aim of this study is to evaluate the adjuvant effect of the probiotic Limosilactobacillus reuteri in the mechanical treatment of peri-implant mucositis. This study aims to include 32 subjects with implant-supported total rehabilitation and peri-implant mucositis, divided into test and control groups, equally subjected to professional mechanical debridement, with the administration of a daily GUM® PerioBalance® lozenge for 30 days added to the test group. Plaque Index, Bleeding Index and probing pocket depth are evaluated before the intervention (baseline) and at 6 and 10 weeks later.


Eligibility criteria: Inclusion Criteria:

(i) dental implants placed for at least 12 months according to the All-on-4® concept;

(ii) removal of the dental prosthesis as part of the conventional implant maintenance protocol;

(iii) modified Bleeding Index19 score \>0 in at least one implant in the studied rehabilitation;

(iv) implants connected to the prosthesis by means of transepithelial abutments;

(v) if there were natural teeth in opposing arch, they were periodontally healthy or had been treated for periodontitis and were on periodontal support with residual pockets ≤5mm;

(vi) demonstrated previous compliance with oral hygiene appointments; (vii) read and signed the informed consent.

Exclusion Criteria:

(i) Peri-implantitis proven clinically (implant mobility, suppuration and/or pocket depth (PD) ≥5mm) and/or radiographically (bone remodeling greater than 2mm in the first year of function20 and mean marginal bone loss greater than 0.2mm for each subsequent year21 in the rehabilitated arch that was intended to be studied);

(ii) clinically active peri-implantitis (mobility, suppuration and/or PD ≥5mm) in the opposing arch to the one intended to be studied;

(iii) presence of an extra-maxillary/zygomatic implant in the rehabilitated arch that was intended to be studied;

(iv) current probiotic supplementation;

(v) diabetes mellitus not controlled by medication;

(vi) current use of oral hygiene products containing chlorohexidine or essential oils;

(vii) special needs individuals who depended on others for their oral hygiene and medication uptake.

Primary outcomes:
measure: Modified bleeding index
timeFrame: baseline, 6 weeks, 10 weeks
Secondary outcomes:
measure: Modified plaque index
timeFrame: baseline, 6 weeks, 10 weeks
measure: Probing pocket depth
timeFrame: baseline, 6 weeks, 10 weeks
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Malo Clinic
Study officials:
affiliation: Maló Clinic
name: Gonçalo Parreira, MSc
role: PRINCIPAL_INVESTIGATOR
References: