Peri-implant MucositisLRRCTNCT05758103
Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis
A study testing Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains) in people with Peri-implant Mucositis, run by Malo Clinic at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Jan 2022to 18 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- dental implants placed for at least 12 months according to the All-on-4® concept;
- removal of the dental prosthesis as part of the conventional implant maintenance protocol;
- modified Bleeding Index19 score >0 in at least one implant in the studied rehabilitation;
- implants connected to the prosthesis by means of transepithelial abutments;
- 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;
- demonstrated previous compliance with oral hygiene appointments; (vii) read and signed the informed consent.
Who cannot join
- 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);
- clinically active peri-implantitis (mobility, suppuration and/or PD ≥5mm) in the opposing arch to the one intended to be studied;
- presence of an extra-maxillary/zygomatic implant in the rehabilitated arch that was intended to be studied;
- current probiotic supplementation;
- diabetes mellitus not controlled by medication;
- current use of oral hygiene products containing chlorohexidine or essential oils;
- special needs individuals who depended on others for their oral hygiene and medication uptake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis in Total Rehabilitation: an Exploratory Study
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
- Being tested
- Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)
- Keywords
- probiotic, Limosilactobacillus reuteri, dental implant, peri-implant mucositis, total rehabilitation, mechanical therapy, nonsurgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks, 10 weeks
Secondary outcomes (2)
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.
Measured: baseline, 6 weeks, 10 weeks
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.
Measured: baseline, 6 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start5 Jan 2022
- Primary completion31 May 2022
- Study completion18 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-group parallel design
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gonçalo Parreira, MSc, Principal investigator, Maló Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758103
- Sponsor's protocol ID
- LRRCT
- Acronym
- LRRCT
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request to the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis in Total Rehabilitation: an Exploratory Study
- ClinicalTrials.gov ID
- NCT05758103
- Acronym / sponsor ID
- LRRCT / LRRCT
- Conditions
- Peri-implant Mucositis
- Keywords
- probiotic, Limosilactobacillus reuteri, dental implant, peri-implant mucositis, total rehabilitation, mechanical therapy, nonsurgical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Malo ClinicUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 18 Sep 2022 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-group parallel design
| Arm | Type | Receives |
|---|---|---|
| Mechanical debridement + probiotic supplement | Experimental | Dietary 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 and probiotic 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- dental implants placed for at least 12 months according to the All-on-4® concept;
- removal of the dental prosthesis as part of the conventional implant maintenance protocol;
- modified Bleeding Index19 score >0 in at least one implant in the studied rehabilitation;
- implants connected to the prosthesis by means of transepithelial abutments;
- 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;
Key exclusion criteria (7 listed)
- 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);
- clinically active peri-implantitis (mobility, suppuration and/or PD ≥5mm) in the opposing arch to the one intended to be studied;
- presence of an extra-maxillary/zygomatic implant in the rehabilitated arch that was intended to be studied;
- current probiotic supplementation;
- diabetes mellitus not controlled by medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Dietary supplement | Mechanical debridement + probiotic supplement |
Primary outcome
Modified bleeding index
Time frame: baseline, 6 weeks, 10 weeks
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.
2 secondary outcomes
Modified plaque index
Time frame: baseline, 6 weeks, 10 weeks
Probing pocket depth
Time frame: baseline, 6 weeks, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Yes. Upon reasonable request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonçalo Parreira, MSc principal investigator
Maló Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains) in people with Peri-implant Mucositis, run by Malo Clinic at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified bleeding index (time frame: baseline, 6 weeks, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.