Peri-implantitisNCT07500844
Decontamination Methods in the Treatment of Peri-implantitis
A study testing Miramistin, Sodium Bicarbonate Powder and Chlorhexidine in people with Peri-implantitis, run by Research Centre for Medical Genetics, Russian Federation at 1 site in Russia.
Trial summary
The goal of this clinical study is to compare the effectiveness of different methods for decontaminating dental implant surfaces in the treatment of peri-implantitis. The main question it aims to answer is: Which combination of an antiseptic solution and an air-polishing powder is most effective for the non-surgical… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Miramistin, Sodium Bicarbonate Powder and Chlorhexidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2023to 11 Dec 2025
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 75 years
- Presence of at least one dental implant
- Diagnosis of peri-implantitis defined as probing depth ≥ 6 mm and radiographic bone loss ≥ 3 mm apical to the most coronal portion of the intraosseous part of the implant
- Ability to attend follow-up appointments for up to 3 months
- Willingness to participate and provide written informed consent
Who cannot join
- Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes mellitus, severe cardiovascular disease, psychotic disorders, active oncological disease)
- Current or prior use of immunosuppressive drugs, bisphosphonates, high-dose corticosteroids, antipsychotics, or other medications known to negatively affect peri-implant tissue regeneration and healing
- Pregnancy or lactation
- Unwillingness or inability to comply with study procedures
- Peri-implantitis requiring immediate surgical intervention or implant removal at baseline
Trial locations and contacts
1 site in 1 country.
Russia1 site
Pirogov Russian National Research Medical University
Moscow, 119021
About this study
Official title: Treatment of Peri-implantitis by Air-polishing Abrasives and Antiseptics Solutions
The goal of this clinical study is to compare the effectiveness of different methods for decontaminating dental implant surfaces in the treatment of peri-implantitis. The main question it aims to answer is:
Which combination of an antiseptic solution and an air-polishing powder is most effective for the non-surgical treatment of peri-implantitis? Researchers will compare three different treatment combinations (Miramistin with sodium bicarbonate, chlorhexidine with erythritol, and Octenisept with glycine) in patients diagnosed with peri-implantitis. Participants will receive the combined treatment at intervals of 7-10 days for one month. The study will assess changes in probing depth, bleeding, and bone loss at 1 and 2.5 months after treatment to determine the most effective and balanced approach for preserving implant surfaces and promoting tissue healing.
Read the detailed description
This is a prospective, interventional study involving 48 patients diagnosed with peri-implantitis.
Groups: Participants were allocated into three groups (n=16 per group) to receive one of three treatment combinations.
Group 1: Treatment with Miramistin solution (0.01%) and air-polishing with sodium bicarbonate powder.
Group 2: Treatment with Chlorhexidine solution (0.05%) and air-polishing with erythritol powder.
Group 3: Treatment with Octenisept solution and air-polishing with glycine powder.
Intervention: Each patient received the assigned combination treatment at intervals of 7-10 days over one month.
Outcome Measures: Clinical parameters were assessed at baseline, 1 month, and 2.5 months after the start of treatment:
Primary Clinical Outcomes: Changes in probing depth (PD) and bleeding on probing (BOP).
Secondary Clinical Outcomes: Changes in plaque index (PLI), gingival index (GI), presence of suppuration, and radiographic bone loss (assessed via periapical radiographs and cone-beam computed tomography (CBCT)). The need for subsequent surgical intervention was also recorded.
- Conditions
- Peri-implantitis
- Being tested
- Miramistin, Sodium Bicarbonate Powder, Chlorhexidine, Erythritol Powder, Octenisept
- Keywords
- peri-implantitis, antiseptic solution, air-water polishing
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiramistinDrug
Antiseptic solution (0.01%) used for irrigation of the peri-implant pocket.
Sodium Bicarbonate PowderProcedure or surgery
Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle
ChlorhexidineDrug
Antiseptic solution (0.05%) used for irrigation of the peri-implant pocket.
Erythritol PowderProcedure or surgery
Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle.
OcteniseptDrug
Antiseptic solution used for irrigation of the peri-implant pocket.
Glycine PowderProcedure or surgery
Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle.
| Study group | Role | What they receive |
|---|---|---|
| Miramistin + Sodium Bicarbonate | Experimental | Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Miramistin antiseptic solution (0.01%) and air-polishing with sodium bicarbonate powder. The treatment is applied at intervals of 7-10 days for a total duration of one month. Receives: Drug: Miramistin; Procedure: Sodium Bicarbonate Powder |
| Chlorhexidine + Erythritol | Active comparator | Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Chlorhexidine antiseptic solution (0.05%) and air-polishing with erythritol powder. The treatment is applied at intervals of 7-10 days for a total duration of one month. Receives: Drug: Chlorhexidine; Procedure: Erythritol Powder |
| Octenisept + Glycine | Active comparator | Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Octenisept antiseptic solution and air-polishing with glycine powder. The treatment is applied at intervals of 7-10 days for a total duration of one month. Receives: Drug: Octenisept; Procedure: Glycine Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Probing depth measured in millimeters using a graduated periodontal probe (UNC-15) at six sites per implant: mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual. The mean probing depth per implant is calculated. A reduction in probing depth indicates treatment success.
Measured: Baseline, 1 month, and 2.5 months after start of treatment
Bleeding on Probing
Presence or absence of bleeding within 30 seconds after gentle probing at six sites per implant. The percentage of sites showing bleeding per implant is recorded. A decrease in bleeding on probing indicates improvement in peri-implant soft tissue health.
Measured: Baseline, 1 month, and 2.5 months after start of treatment
Secondary outcomes (5)
Plaque Index
Plaque accumulation assessed using the Silness-Löe Plaque Index (0-3 scale) at six sites per implant. Mean PLI is calculated per implant.
Measured: Baseline, 1 month, and 2.5 months after start of treatment
Gingival Index
Gingival inflammation assessed using the Löe-Silness Gingival Index (0-3 scale) at six sites per implant. Mean GI is calculated per implant.
Measured: Baseline, 1 month, and 2.5 months after start of treatment
Radiographic Bone Loss
Vertical bone loss measured in millimeters from a fixed reference point (e.g., implant shoulder) to the most coronal bone-to-implant contact, assessed on periapical radiographs and cone-beam computed tomography (CBCT).
Measured: Baseline and 2.5 months after start of treatment
Need for Surgical Intervention
Number and severity of adverse events related to the treatment, including post-operative pain, soft tissue irritation, allergic reactions, or any unexpected events.
Measured: From start of treatment through 2.5 months
Suppuration
Presence or absence of suppuration (purulent exudate) after gentle probing. Reported as the percentage of sites with suppuration per implant.
Measured: Baseline, 1 month, and 2.5 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Feb 2023
- Primary completion30 Nov 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Centre for Medical Genetics, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elena Strandstrem, Research Centre for Medical Genetics, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500844
- Sponsor's protocol ID
- 1/21
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a preliminary clinical study with a small sample size from a single center. Individual participant data will not be shared due to privacy considerations and the limited scope of the investigation.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Peri-implantitis by Air-polishing Abrasives and Antiseptics Solutions
- ClinicalTrials.gov ID
- NCT07500844
- Acronym / sponsor ID
- 1/21
- Conditions
- Peri-implantitis
- Keywords
- peri-implantitis, antiseptic solution, air-water polishing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Research Centre for Medical Genetics, Russian FederationOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 30 Mar 2026 (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.
The goal of this clinical study is to compare the effectiveness of different methods for decontaminating dental implant surfaces in the treatment of peri-implantitis. The main question it aims to answer is:
Which combination of an antiseptic solution and an air-polishing powder is most effective for the non-surgical treatment of peri-implantitis? Researchers will compare three different treatment combinations (Miramistin with sodium bicarbonate, chlorhexidine with erythritol, and Octenisept with glycine) in patients diagnosed with peri-implantitis. Participants will receive the combined treatment at intervals of 7-10 days for one month. The study will assess changes in probing depth, bleeding, and bone loss at 1 and 2.5 months after treatment to determine the most effective and balanced approach for preserving implant surfaces and promoting tissue healing.
Detailed description
This is a prospective, interventional study involving 48 patients diagnosed with peri-implantitis.
Groups: Participants were allocated into three groups (n=16 per group) to receive one of three treatment combinations.
Group 1: Treatment with Miramistin solution (0.01%) and air-polishing with sodium bicarbonate powder.
Group 2: Treatment with Chlorhexidine solution (0.05%) and air-polishing with erythritol powder.
Group 3: Treatment with Octenisept solution and air-polishing with glycine powder.
Intervention: Each patient received the assigned combination treatment at intervals of 7-10 days over one month.
Outcome Measures: Clinical parameters were assessed at baseline, 1 month, and 2.5 months after the start of treatment:
Primary Clinical Outcomes: Changes in probing depth (PD) and bleeding on probing (BOP).
Secondary Clinical Outcomes: Changes in plaque index (PLI), gingival index (GI), presence of suppuration, and radiographic bone loss (assessed via periapical radiographs and cone-beam computed tomography (CBCT)). The need for subsequent surgical intervention was also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Miramistin + Sodium Bicarbonate | Experimental | Drug: Miramistin, Procedure: Sodium Bicarbonate PowderParticipants in this arm receive non-surgical treatment for peri-implantitis using a combination of Miramistin antiseptic solution (0.01%) and air-polishing with sodium bicarbonate powder. The treatment is applied at intervals of 7-10 days for a total duration of one month. |
| Chlorhexidine + Erythritol | Active comparator | Drug: Chlorhexidine, Procedure: Erythritol PowderParticipants in this arm receive non-surgical treatment for peri-implantitis using a combination of Chlorhexidine antiseptic solution (0.05%) and air-polishing with erythritol powder. The treatment is applied at intervals of 7-10 days for a total duration of one month. |
| Octenisept + Glycine | Active comparator | Drug: Octenisept, Procedure: Glycine PowderParticipants in this arm receive non-surgical treatment for peri-implantitis using a combination of Octenisept antiseptic solution and air-polishing with glycine powder. The treatment is applied at intervals of 7-10 days for a total duration of one month. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 21 and 75 years
- Presence of at least one dental implant
- Diagnosis of peri-implantitis defined as probing depth ≥ 6 mm and radiographic bone loss ≥ 3 mm apical to the most coronal portion of the intraosseous part of the implant
- Ability to attend follow-up appointments for up to 3 months
- Willingness to participate and provide written informed consent
Key exclusion criteria (5 listed)
- Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes mellitus, severe cardiovascular disease, psychotic disorders, active oncological disease)
- Current or prior use of immunosuppressive drugs, bisphosphonates, high-dose corticosteroids, antipsychotics, or other medications known to negatively affect peri-implant tissue regeneration and healing
- Pregnancy or lactation
- Unwillingness or inability to comply with study procedures
- Peri-implantitis requiring immediate surgical intervention or implant removal at baseline
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 |
|---|---|---|
| MiramistinAntiseptic solution (0.01%) used for irrigation of the peri-implant pocket. | Drug | Miramistin + Sodium Bicarbonate |
| Sodium Bicarbonate PowderAbrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle | Procedure or surgery | Miramistin + Sodium Bicarbonate |
| ChlorhexidineAntiseptic solution (0.05%) used for irrigation of the peri-implant pocket. | Drug | Chlorhexidine + Erythritol |
| Erythritol PowderAbrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle. | Procedure or surgery | Chlorhexidine + Erythritol |
| OcteniseptAntiseptic solution used for irrigation of the peri-implant pocket. | Drug | Octenisept + Glycine |
| Glycine PowderAbrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle. | Procedure or surgery | Octenisept + Glycine |
Primary outcome
Probing Depth
Time frame: Baseline, 1 month, and 2.5 months after start of treatment
Probing depth measured in millimeters using a graduated periodontal probe (UNC-15) at six sites per implant: mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual. The mean probing depth per implant is calculated. A reduction in probing depth indicates treatment success.
Bleeding on Probing
Time frame: Baseline, 1 month, and 2.5 months after start of treatment
Presence or absence of bleeding within 30 seconds after gentle probing at six sites per implant. The percentage of sites showing bleeding per implant is recorded. A decrease in bleeding on probing indicates improvement in peri-implant soft tissue health.
5 secondary outcomes
Plaque Index
Time frame: Baseline, 1 month, and 2.5 months after start of treatment
Gingival Index
Time frame: Baseline, 1 month, and 2.5 months after start of treatment
Radiographic Bone Loss
Time frame: Baseline and 2.5 months after start of treatment
Need for Surgical Intervention
Time frame: From start of treatment through 2.5 months
Suppuration
Time frame: Baseline, 1 month, and 2.5 months after start of treatment
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 3 Apr 2026.
- Individual participant dataSharing planned: Undecided. This is a preliminary clinical study with a small sample size from a single center. Individual participant data will not be shared due to privacy considerations and the limited scope of the investigation.
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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.
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 study testing Miramistin, Sodium Bicarbonate Powder and Chlorhexidine in people with Peri-implantitis, run by Research Centre for Medical Genetics, Russian Federation at 1 site in Russia.
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 5 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 3 Apr 2026. 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 Russia. 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?
Probing Depth (time frame: Baseline, 1 month, and 2.5 months after start of treatment). The study lists 2 primary outcomes in all. 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 3 Apr 2026.