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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miramistin | Drug | Antiseptic solution (0.01%) used for irrigation of the peri-implant pocket. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 1 month, and 2.5 months after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, and 2.5 months after start of treatment |
| Gingival Index |
| Measure | Description | Time Frame |
|---|---|---|
| Safety / Adverse Events | Number and severity of adverse events related to the treatment, including post-operative pain, soft tissue irritation, allergic reactions, or any unexpected events. | From start of treatment through 2.5 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pirogov Russian National Research Medical University | Moscow | 119021 | Russia |
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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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 14, 2026 | |
| Reset | Jun 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 14, 2026 | Jun 9, 2026 | |||
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C058048 | miramistin |
| D002710 | Chlorhexidine |
| C000718682 | octenidine and phenoxyethanol drug combination |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Sodium Bicarbonate Powder | Procedure | Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle |
|
| Chlorhexidine | Drug | Antiseptic solution (0.05%) used for irrigation of the peri-implant pocket. |
|
| Erythritol Powder | Procedure | Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle. |
|
| Octenisept | Drug | Antiseptic solution used for irrigation of the peri-implant pocket. |
|
| Glycine Powder | Procedure | Abrasive powder used for air-polishing debridement of the implant surface at a 45-degree angle. |
|
Gingival inflammation assessed using the Löe-Silness Gingival Index (0-3 scale) at six sites per implant. Mean GI is calculated per implant.
| 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). | 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. | 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. | Baseline, 1 month, and 2.5 months after start of treatment |