Mucositis OralPhase 3Mucosite probNCT04187222
Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis in Peri-implant Mucositis
A Phase 3 study testing Mechanical debridements and Bifidobacterium animalis subsp. lactis in people with Mucositis Oral, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Peri-implant disease is an inflammatory process of bacterial etiology that can affect the tissues around the implants and can be classified as peri-implant mucositis or peri-implantitis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mucositis Oral
- What is being tested?
- Mechanical debridements and Bifidobacterium animalis subsp. lactis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2018to 15 Nov 2019
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- completely edentulous lower or upper dental arch undergoing rehabilitation with dental implants;
- prosthetic restoration in function for at least 6 months;
- healthy individuals with no known systemic changes;
- non smokers.
Who cannot join
- patients who have received any type of local or systemic oral cavity decontamination treatment within the last 3 months or periodontal treatment within the last 6 months; uncontrolled periodontal disease;
- patients with systemic disorders capable of influencing treatment outcomes;
- smokers;
- lack of informed consent to participate in the study;
- presence of bone loss greater than 2 mm in dental implants.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry of Ribeirao Preto - University of São Paulo
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: Clinical Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis as Adjunctive Therapy in Non-surgical Treatment of Periimplant Mucositis: a Randomized Controlled Trial
Peri-implant disease is an inflammatory process of bacterial etiology that can affect the tissues around the implants and can be classified as peri-implant mucositis or peri-implantitis. The confirmation of the action of probiotics against microorganisms that cause peri-implant diseases can represent a great advance in the treatment of these diseases that affect a large part of the population, and may even reduce or prevent the use of antibiotics, reducing the risk of implant loss and, consequently, greater damage to the oral and systemic health of individuals. The purpose of this study was to evaluate the action of probiotics on the peri-implant health of total edentulous patients using Branemark protocol prosthetic rehabilitations. For this, 38 patients were selected, without systemic alterations and non-smokers. Clinical monitoring was performed at baseline (pre-intervention period) as well as at 12 and 24 weeks after study initiation. The following parameters were evaluated: modified gingival index (MGI), modified plaque index (MPI), probing depth (PD) and probing bleeding (PB). Data were subjected to statistical analysis at a significance level of 5%. There was an increase in sites with IGM 0 in the test group at 12 and 24 weeks. The test group presented more sites with IGM 0 than the control. IPM 0 sites increased in the control group at 12 and 24 weeks in the control group. PD decreases in a test and control group. Finally, the test group had lower PB rates. Thus, the probiotic used demonstrated ability to contribute to the improvement of peri-implant health of the patients analyzed.
Read the detailed description
Clinical monitoring. MGI (0: no bleeding when a periodontal tube is passed along the mucosal margin adjacent to the implant; 1: visible isolated bleeding points; 2: blood forms a confluent red line at the mucosal margin and 3: profuse bleeding) and the MPI (0: no plaque; 1: plaque recognized only by probing through the smooth marginal surface of the implant; 2: plaque can be seen with the naked eye; 3: abundance of alba matter). PD was determined using a soft plastic periodontal probe for torque-controlled implants at 0.15 N / cm. Three buccal and three lingual reference points for each implant were used to calculate the mean probing depth in millimeters for each implant. PB was dichotomously evaluated: the presence of bleeding was considered positive when it occurred within 20 seconds after insertion of the probe to measure PD. The height of the keratinized mucosa present around each implant was also measured.
All clinical parameters described above were recorded at baseline (pre-intervention period) as well as at 12 and 24 weeks after study initiation.
Treatment of peri-implant mucositis and maintenance care. Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curves and polishing using a rubber bowl and polishing paste. In the Test Group the treatment session was completed by a professional topical application around the carboxymethylcellulose gel implants containing 109 colony (CFU) forming units of B. lactis HN019. The gel was applied sub and supragingivally. The patients then received commercial capsules containing the same bacteria and were instructed to dissolve the capsule contents in 20 mL of water and rinse for 30 to 60 seconds, followed by swallowing twice a day for 12 weeks. The control group received the same oral hygiene instructions, mechanical debridement and was treated with gel and placebo tablets. At 3 months postoperatively, the same local mechanical and chemical treatment was repeated for the Test and Control groups.
- Conditions
- Mucositis Oral
- Being tested
- Mechanical debridements, Bifidobacterium animalis subsp. lactis
- Keywords
- Dental implants, Mucositis, Probiotics, Bleeding on probing
- Medical subject headings
- Stomatitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical debridementsOther
Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curette and polishing using a rubber bowl and polishing paste.
Bifidobacterium animalis subsp. lactisBiological
Capsules containing Bifidobacterium animalis subsp. lactis were chubby and subsequently ingested twice a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Mechanical treatment + Bifidobacterium animalis subsp. lactis Receives: Other: Mechanical debridements; Biological: Bifidobacterium animalis subsp. lactis |
| Control Group | Placebo comparator | Mechanical treatment + Placebo Receives: Other: Mechanical debridements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding the probing.
Measured: Baseline.
Bleeding the probing.
Measured: 12 weeks.
Bleeding the probing.
Measured: 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jul 2018
- Primary completion31 Aug 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mucositis OralStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Treatment of peri-implant mucositis and maintenance care Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curves and polishing using a rubber bowl and polishing paste. In the Test Group the treatment session was completed by a professional topical application around the carboxymethylcellulose gel implants containing 109 CFLs of B. lactis HN019. The gel was applied sub and supragingivally. The patients then received commercial capsules containing the same bacteria and were instructed to dissolve the capsule contents in 20 mL of water and rinse for 30 to 60 seconds, followed by swallowing twice a day for 12 weeks. The control group received the same oral hygiene instructions, mechanical debridement and was treated with gel and placebo tablets. At 3 months postoperatively, the same local mechanical and chemical treatment was repeated for the Test and Control groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reis Messora, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187222
- Sponsor's protocol ID
- 82840117.4.0000.5419
- Acronym
- Mucosite prob
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mongardini C, Pilloni A, Farina R, Di Tanna G, Zeza B. Adjunctive efficacy of probiotics in the treatment of experimental peri-implant mucositis with mechanical and photodynamic therapy: a randomized, cross-over clinical trial. J Clin Periodontol. 2017 Apr;44(4):410-417. doi: 10.1111/jcpe.12689. Epub 2017 Feb 18.
PubMed 28032908Hallstrom H, Lindgren S, Widen C, Renvert S, Twetman S. Probiotic supplements and debridement of peri-implant mucositis: a randomized controlled trial. Acta Odontol Scand. 2016;74(1):60-6. doi: 10.3109/00016357.2015.1040065. Epub 2015 May 8.
PubMed 25953193Flichy-Fernandez AJ, Ata-Ali J, Alegre-Domingo T, Candel-Marti E, Ata-Ali F, Palacio JR, Penarrocha-Diago M. The effect of orally administered probiotic Lactobacillus reuteri-containing tablets in peri-implant mucositis: a double-blind randomized controlled trial. J Periodontal Res. 2015 Dec;50(6):775-85. doi: 10.1111/jre.12264. Epub 2015 Feb 25.
PubMed 25712760Santana SI, Silva PHF, Salvador SL, Casarin RCV, Furlaneto FAC, Messora MR. Adjuvant use of multispecies probiotic in the treatment of peri-implant mucositis: A randomized controlled trial. J Clin Periodontol. 2022 Aug;49(8):828-839. doi: 10.1111/jcpe.13663. Epub 2022 Jun 10.
PubMed 35634695
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis as Adjunctive Therapy in Non-surgical Treatment of Periimplant Mucositis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04187222
- Acronym / sponsor ID
- Mucosite prob / 82840117.4.0000.5419
- Conditions
- Mucositis Oral
- Keywords
- Dental implants, Mucositis, Probiotics, Bleeding on probing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 5 Dec 2019 (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.
Peri-implant disease is an inflammatory process of bacterial etiology that can affect the tissues around the implants and can be classified as peri-implant mucositis or peri-implantitis. The confirmation of the action of probiotics against microorganisms that cause peri-implant diseases can represent a great advance in the treatment of these diseases that affect a large part of the population, and may even reduce or prevent the use of antibiotics, reducing the risk of implant loss and, consequently, greater damage to the oral and systemic health of individuals. The purpose of this study was to evaluate the action of probiotics on the peri-implant health of total edentulous patients using Branemark protocol prosthetic rehabilitations. For this, 38 patients were selected, without systemic alterations and non-smokers. Clinical monitoring was performed at baseline (pre-intervention period) as well as at 12 and 24 weeks after study initiation. The following parameters were evaluated: modified gingival index (MGI), modified plaque index (MPI), probing depth (PD) and probing bleeding (PB). Data were subjected to statistical analysis at a significance level of 5%. There was an increase in sites with IGM 0 in the test group at 12 and 24 weeks. The test group presented more sites with IGM 0 than the control. IPM 0 sites increased in the control group at 12 and 24 weeks in the control group. PD decreases in a test and control group. Finally, the test group had lower PB rates. Thus, the probiotic used demonstrated ability to contribute to the improvement of peri-implant health of the patients analyzed.
Detailed description
Clinical monitoring. MGI (0: no bleeding when a periodontal tube is passed along the mucosal margin adjacent to the implant; 1: visible isolated bleeding points; 2: blood forms a confluent red line at the mucosal margin and 3: profuse bleeding) and the MPI (0: no plaque; 1: plaque recognized only by probing through the smooth marginal surface of the implant; 2: plaque can be seen with the naked eye; 3: abundance of alba matter). PD was determined using a soft plastic periodontal probe for torque-controlled implants at 0.15 N / cm. Three buccal and three lingual reference points for each implant were used to calculate the mean probing depth in millimeters for each implant. PB was dichotomously evaluated: the presence of bleeding was considered positive when it occurred within 20 seconds after insertion of the probe to measure PD. The height of the keratinized mucosa present around each implant was also measured.
All clinical parameters described above were recorded at baseline (pre-intervention period) as well as at 12 and 24 weeks after study initiation.
Treatment of peri-implant mucositis and maintenance care. Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curves and polishing using a rubber bowl and polishing paste. In the Test Group the treatment session was completed by a professional topical application around the carboxymethylcellulose gel implants containing 109 colony (CFU) forming units of B. lactis HN019. The gel was applied sub and supragingivally. The patients then received commercial capsules containing the same bacteria and were instructed to dissolve the capsule contents in 20 mL of water and rinse for 30 to 60 seconds, followed by swallowing twice a day for 12 weeks. The control group received the same oral hygiene instructions, mechanical debridement and was treated with gel and placebo tablets. At 3 months postoperatively, the same local mechanical and chemical treatment was repeated for the Test and Control groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment of peri-implant mucositis and maintenance care Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curves and polishing using a rubber bowl and polishing paste. In the Test Group the treatment session was completed by a professional topical application around the carboxymethylcellulose gel implants containing 109 CFLs of B. lactis HN019. The gel was applied sub and supragingivally. The patients then received commercial capsules containing the same bacteria and were instructed to dissolve the capsule contents in 20 mL of water and rinse for 30 to 60 seconds, followed by swallowing twice a day for 12 weeks. The control group received the same oral hygiene instructions, mechanical debridement and was treated with gel and placebo tablets. At 3 months postoperatively, the same local mechanical and chemical treatment was repeated for the Test and Control groups.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Mechanical debridements, Biological: Bifidobacterium animalis subsp. lactisMechanical treatment + Bifidobacterium animalis subsp. lactis |
| Control Group | Placebo comparator | Other: Mechanical debridementsMechanical treatment + Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- completely edentulous lower or upper dental arch undergoing rehabilitation with dental implants;
- prosthetic restoration in function for at least 6 months;
- healthy individuals with no known systemic changes;
- non smokers.
Key exclusion criteria (5 listed)
- patients who have received any type of local or systemic oral cavity decontamination treatment within the last 3 months or periodontal treatment within the last 6 months; uncontrolled periodontal disease;
- patients with systemic disorders capable of influencing treatment outcomes;
- smokers;
- lack of informed consent to participate in the study;
- presence of bone loss greater than 2 mm in dental implants.
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 |
|---|---|---|
| Mechanical debridementsPrior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curette and polishing using a rubber bowl and polishing paste. | Other | Control Group, Test Group |
| Bifidobacterium animalis subsp. lactisCapsules containing Bifidobacterium animalis subsp. lactis were chubby and subsequently ingested twice a day for 12 weeks. | Biological | Test Group |
Primary outcome
Bleeding the probing.
Time frame: Baseline.
Bleeding the probing.
Time frame: 12 weeks.
Bleeding the probing.
Time frame: 24 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 5 Dec 2019.
- Background: PubMed 28032908Mongardini C, Pilloni A, Farina R, Di Tanna G, Zeza B. Adjunctive efficacy of probiotics in the treatment of experimental peri-implant mucositis with mechanical and photodynamic therapy: a randomized, cross-over clinical trial. J Clin Periodontol. 2017 Apr;44(4):410-417. doi: 10.1111/jcpe.12689. Epub 2017 Feb 18.
- Background: PubMed 25953193Hallstrom H, Lindgren S, Widen C, Renvert S, Twetman S. Probiotic supplements and debridement of peri-implant mucositis: a randomized controlled trial. Acta Odontol Scand. 2016;74(1):60-6. doi: 10.3109/00016357.2015.1040065. Epub 2015 May 8.
- Background: PubMed 25712760Flichy-Fernandez AJ, Ata-Ali J, Alegre-Domingo T, Candel-Marti E, Ata-Ali F, Palacio JR, Penarrocha-Diago M. The effect of orally administered probiotic Lactobacillus reuteri-containing tablets in peri-implant mucositis: a double-blind randomized controlled trial. J Periodontal Res. 2015 Dec;50(6):775-85. doi: 10.1111/jre.12264. Epub 2015 Feb 25.
- Derived from this study: PubMed 35634695Santana SI, Silva PHF, Salvador SL, Casarin RCV, Furlaneto FAC, Messora MR. Adjuvant use of multispecies probiotic in the treatment of peri-implant mucositis: A randomized controlled trial. J Clin Periodontol. 2022 Aug;49(8):828-839. doi: 10.1111/jcpe.13663. Epub 2022 Jun 10.
Related trials for Mucositis Oral
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mechanical debridements and Bifidobacterium animalis subsp. lactis in people with Mucositis Oral, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 5 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 5 Dec 2019. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bleeding the probing. (time frame: Baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187222, which also lists 4 linked publications.
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 5 Dec 2019.