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

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)
Sponsored by
Malo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring probiotic, Limosilactobacillus reuteri, dental implant, peri-implant mucositis, total rehabilitation, mechanical therapy, nonsurgical treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Malo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mechanical debridement + probiotic supplement

Mechanical debridement

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Modified plaque index
Change of the bacterial plaque score on each dental implant from baseline to 6 weeks and from baseline to10 weeks. Modified plaque index- 0: absence of plaque; 1: plaque only visible after running the periodontal probe through the peri-implant sulcus around the implant; 2: plaque visible by the naked eye; 3: abundance of soft matter.
Probing pocket depth
Change of the probing pocket depth in milimeters on each dental implant from baseline to 6 weeks and from baseline to10 weeks. Values over 4 mm might indicate the presence of an acute or chronical peri-implant condition.

Full Information

First Posted
February 23, 2023
Last Updated
March 4, 2023
Sponsor
Malo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05758103
Brief Title
Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis
Acronym
LRRCT
Official Title
Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis in Total Rehabilitation: an Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
September 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
Keywords
probiotic, Limosilactobacillus reuteri, dental implant, peri-implant mucositis, total rehabilitation, mechanical therapy, nonsurgical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two-group parallel design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mechanical debridement + probiotic supplement
Arm Type
Experimental
Arm Description
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).
Arm Title
Mechanical debridement
Arm Type
No Intervention
Arm Description
Patients with peri-implant mucositis treated through non-surgical professional mechanical debridement alone
Intervention Type
Dietary Supplement
Intervention Name(s)
Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)
Intervention Description
Non-surgical professional mechanical debridement and probiotic supplement Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)
Primary Outcome Measure Information:
Title
Modified bleeding index
Description
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.
Time Frame
baseline, 6 weeks, 10 weeks
Secondary Outcome Measure Information:
Title
Modified plaque index
Description
Change of the bacterial plaque score on each dental implant from baseline to 6 weeks and from baseline to10 weeks. Modified plaque index- 0: absence of plaque; 1: plaque only visible after running the periodontal probe through the peri-implant sulcus around the implant; 2: plaque visible by the naked eye; 3: abundance of soft matter.
Time Frame
baseline, 6 weeks, 10 weeks
Title
Probing pocket depth
Description
Change of the probing pocket depth in milimeters on each dental implant from baseline to 6 weeks and from baseline to10 weeks. Values over 4 mm might indicate the presence of an acute or chronical peri-implant condition.
Time Frame
baseline, 6 weeks, 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonçalo Parreira, MSc
Organizational Affiliation
Maló Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malo Clinic
City
Lisbon
ZIP/Postal Code
1600-042
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon reasonable request to the Principal Investigator

Learn more about this trial

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

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