NCT07500844

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

peri-implantitisantiseptic solutionair-water polishing

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • Plaque Index

    Baseline, 1 month, and 2.5 months after start of treatment

  • Gingival Index

    Baseline, 1 month, and 2.5 months after start of treatment

  • Radiographic Bone Loss

    Baseline and 2.5 months after start of treatment

  • Need for Surgical Intervention

    From start of treatment through 2.5 months

  • Suppuration

    Baseline, 1 month, and 2.5 months after start of treatment

Other Outcomes (1)

  • Safety / Adverse Events

    From start of treatment through 2.5 months

Study Arms (3)

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.

Combination Product: Miramistin + Sodium Bicarbonate

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.

Combination Product: Chlorhexidine and Erythritol Decontamination Protocol

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.

Combination Product: Octenisept and Glycine Decontamination Protocol

Interventions

A non-surgical implant surface decontamination protocol combining a chemical antiseptic and a mechanical air-polishing abrasive. The intervention is applied in a clinical setting at intervals of 7-10 days for one month. First, the peri-implant pocket is irrigated with Miramistin solution (0.01%). Subsequently, the implant surface is treated with air-polishing using sodium bicarbonate powder directed at a 45-degree angle to remove the biofilm.

Also known as: Miramistin 0.01% and Sodium Bicarbonate
Miramistin + Sodium Bicarbonate

This is a non-surgical decontamination protocol for the treatment of peri-implantitis, combining a chemical antiseptic agent with a mechanical air-polishing abrasive. The treatment is applied in a clinical setting at intervals of 7-10 days over a total duration of one month. The procedure involves the application of an antiseptic solution (Chlorhexidine) to the affected peri-implant site, followed by mechanical debridement of the implant surface using air-polishing with a specific abrasive powder (\[Name of Powder\]). The abrasive flow is directed at a 45-degree angle to the implant surface to effectively disrupt and remove the bacterial biofilm. The goal of this combined approach is to achieve effective bacterial decontamination while preserving the integrity of the implant surface and minimizing cytotoxicity to surrounding tissues to promote healing.

Chlorhexidine + Erythritol

This is a non-surgical decontamination protocol for the treatment of peri-implantitis, combining a chemical antiseptic agent with a mechanical air-polishing abrasive. The treatment is applied in a clinical setting at intervals of 7-10 days over a total duration of one month. The procedure involves the application of an antiseptic solution (Octenisept) to the affected peri-implant site, followed by mechanical debridement of the implant surface using air-polishing with a specific abrasive powder (Glycine). The abrasive flow is directed at a 45-degree angle to the implant surface to effectively disrupt and remove the bacterial biofilm. The goal of this combined approach is to achieve effective bacterial decontamination while preserving the integrity of the implant surface and minimizing cytotoxicity to surrounding tissues to promote healing.

Octenisept + Glycine

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pirogov Russian National Research Medical University

Moscow, 119021, Russia

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

miramistinSodium BicarbonateChlorhexidineoctenidine and phenoxyethanol drug combination

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

February 1, 2023

Primary Completion

November 30, 2025

Study Completion

December 11, 2025

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations