Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis

NCT05758103 | Completed DMC

• 1 other identifier: LRRCT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis

Keywords

probiotic; Limosilactobacillus reuteri; dental implant; peri-implant mucositis; total rehabilitation; mechanical therapy; nonsurgical treatment

Outcome Measures

Primary Outcomes (1)

• Modified bleeding index

  Change of the bleeding score on each dental implant from baseline to 6 weeks and from baseline to10 weeks. Modified bleeding index- 0: absence of bleeding; 1: isolated bleeding spots visible; 2: blood forms a confluent red line on margin; 3: heavy or profuse bleeding.

  baseline, 6 weeks, 10 weeks

Secondary Outcomes (2)

• Modified plaque index

  baseline, 6 weeks, 10 weeks

• Probing pocket depth

  baseline, 6 weeks, 10 weeks

Study Arms (2)

Mechanical debridement + probiotic supplement

EXPERIMENTAL

Patients with peri-implant mucositis treated through non-surgical professional mechanical debridement and probiotic supplement Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains).

Dietary Supplement: Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)

Mechanical debridement

NO INTERVENTION

Patients with peri-implant mucositis treated through non-surgical professional mechanical debridement alone

Interventions

Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains) DIETARY_SUPPLEMENT

Non-surgical professional mechanical debridement and probiotic supplement Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)

Mechanical debridement + probiotic supplement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Malo Clinic: lead

Study Sites (1)

Malo Clinic

Lisbon, 1600-042, Portugal

Location

Study Officials

• Gonçalo Parreira, MSc

  Maló Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-group parallel design

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: January 5, 2022
• Primary Completion: May 31, 2022
• Study Completion: September 18, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PT (1)