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

NCT ID: NCT05758103

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2022-09-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mechanical debridement + probiotic supplement

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Malo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gonçalo Parreira, MSc

Role: PRINCIPAL_INVESTIGATOR

Maló Clinic

Locations

Malo Clinic

Lisbon, , Portugal

Countries

Portugal

Other Identifiers

LRRCT

Identifier Type: -

Identifier Source: org_study_id