Peri-implant InflammationNCT06730568
Effect of Different Non-surgical Treatment Approaches of Peri-implantitis
A study testing Submarginal mechanical instrumentation, Submarginal mechanical instrumentation and chlorhexidine irrigation and Submarginal mechanical instrumentation and ozone application in people with Peri-implant Inflammation and Peri-Implantitis and Peri-implant Mucositis, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
Peri-implantitis is a biofilm-associated pathological condition characterized by inflammation within the peri-implant mucosa, which leads to the progressive loss of the surrounding supporting bone tissue. The primary goal of managing peri-implantitis is to control the peri-implant biofilm and resolve inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Inflammation, Peri-Implantitis and Peri-implant Mucositis, Non-surgical Treatment
- What is being tested?
- Submarginal mechanical instrumentation, Submarginal mechanical instrumentation and chlorhexidine irrigation and Submarginal mechanical instrumentation and ozone application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2017to 4 Jun 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the presence of at least one titanium implant with clinical and radiographic signs of initial to moderate peri-implantitis
- single-unit or partial restorations without overhangings
- absence of occlusal overload
- the presence of at least 2 mm of keratinized attached peri-implant mucosa
- periodontally healthy participants with a good level of oral hygiene
Who cannot join
- the presence of implant mobility
- systemic diseases (i.e. diabetes (HbA1c <7), osteoporosis, bisphosphonate medication) which could affect the outcome of treatment
- smoking
- placement, and prosthetic loading of implants within the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Non-surgical Treatment Approaches of Peri-implantitis: a Multi-arm Randomized Controlled Clinical Trial
Peri-implantitis is a biofilm-associated pathological condition characterized by inflammation within the peri-implant mucosa, which leads to the progressive loss of the surrounding supporting bone tissue. The primary goal of managing peri-implantitis is to control the peri-implant biofilm and resolve inflammation. Nonsurgical treatment of peri-implantitis by submarginal mechanical instrumentation alone typically provides clinical improvements, particularly in non-advanced cases. However, to ensure surface decontamination and enhance treatment outcomes, alternative or adjunctive methods, such as systemic/local antibiotics, antiseptics, lasers, and air-abrasion systems, have been proposed.
Therefore, the null hypothesis (H0) of the present study is that no statistically significant difference would be detected in clinical inflammation signs among patients diagnosed with early-stage peri-implantitis after undergoing one of the following treatments: nonsurgical mechanical instrumentation alone, mechanical instrumentation plus chlorhexidine (CHX), mechanical instrumentation plus gaseous ozone, mechanical instrumentation plus glycine air polishing, or glycine air polishing alone.
- Conditions
- Peri-implant Inflammation, Peri-Implantitis and Peri-implant Mucositis, Non-surgical Treatment
- Being tested
- Submarginal mechanical instrumentation, Submarginal mechanical instrumentation and chlorhexidine irrigation, Submarginal mechanical instrumentation and ozone application, Submarginal mechanical instrumentation and air abrasion, Air abrasion monotherapy
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submarginal mechanical instrumentationProcedure or surgery
Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. No adjunctive therapies were applied in this group.
Submarginal mechanical instrumentation and chlorhexidine irrigationProcedure or surgery
The participants in the mechanical instrumentation with chlorhexidine (MC) group were treated with conventional submarginal instrumentation using titanium curettes. Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. Following mechanical instrumentation, the peri-implant pockets were irrigated with 0.2% chlorhexidine digluconate solution for 1 minute.
Submarginal mechanical instrumentation and ozone applicationProcedure or surgery
The participants in the mechanical instrumentation with ozone (MO) group were treated with conventional submarginal instrumentation using titanium curettes. Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. Following mechanical instrumentation, gaseous ozone was applied to the peri-implant pockets using an ozone-generating device and a specialized glass fiber probe. The ozone gas was delivered to four sites (mesial, distal, buccal, and lingual) for 15 seconds per site, resulting in a total application time of 1 minute per implant. The device operated at a power of 3 watts and 80% oxygen concentration, as recommended by the manufacturer.
Submarginal mechanical instrumentation and air abrasionProcedure or surgery
The participants in the mechanical instrumentation with glycine powder air abrasion (MA) group were treated with conventional submarginal instrumentation using titanium curettes. Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. Following mechanical instrumentation, the peri-implant pockets were treated with glycine powder-based air abrasion using an air-abrasion device (AIR-FLOW® handy 3.0 PERIO HANDPIECE, EMS, Nyon, Switzerland) and a flexible Perio-Flow® nozzle. The nozzle was inserted into the pockets and guided in a circular motion from coronal to apical, parallel to the implant surface, in a non-contact mode as recommended by the manufacturer. The air-abrasion treatment was applied to four sites (mesial, distal, buccal, and lingual) for 5 seconds per site, resulting in a total application time of 20 seconds per implant.
Air abrasion monotherapyProcedure or surgery
The participants in the glycine powder air abrasion monotherapy (A) group were treated exclusively with glycine powder-based air abrasion. Local anesthesia was applied before the procedure. The peri-implant pockets were instrumented with an air-abrasion device using glycine powder and a flexible nozzle. The nozzle was inserted into the pockets and guided in a circular motion from coronal to apical, parallel to the implant surface, in a non-contact mode as recommended by the manufacturer. The air-abrasion treatment was applied to four sites (mesial, distal, buccal, and lingual) for 5 seconds per site, resulting in a total application time of 20 seconds per implant. .
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Instrumentation (M) | Active comparator | The participants in the mechanical instrumentation (M) group were treated with conventional submarginal instrumentation using titanium curettes. Receives: Procedure: Submarginal mechanical instrumentation |
| Mechanical Instrumentation with Chlorhexidine (MC) | Experimental | Participants in the mechanical instrumentation with chlorhexidine (MC) group were treated with conventional submarginal instrumentation using titanium curettes followed by adjunctive chlorhexidine irrigation. Receives: Procedure: Submarginal mechanical instrumentation and chlorhexidine irrigation |
| Mechanical Instrumentation with Ozone (MO) | Experimental | Participants in the mechanical instrumentation with chlorhexidine (MC) group were treated with conventional submarginal instrumentation using titanium curettes followed by gaseous ozone Receives: Procedure: Submarginal mechanical instrumentation and ozone application |
| Mechanical Instrumentation with Air Abrasion (MA) | Experimental | The participants in the mechanical instrumentation with glycine powder air abrasion (MA) group were treated with conventional submarginal instrumentation using titanium curettes and followed by adjunctive glycine air-abrasion. Receives: Procedure: Submarginal mechanical instrumentation and air abrasion |
| Air Abrasion Monotherapy (A) | Experimental | The participants in the air abrasion monotherapy (A) group were treated exclusively with glycine powder-based air abrasion. Receives: Procedure: Air abrasion monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probable Pocket Depth
Measured: Baseline, 3 months, and 6 months after treatment
Secondary outcomes (2)
Bleeding on Probing
Measured: Baseline, 3 months, and 6 months after treatment
Plaque Index
Measured: Baseline, 3 months, and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start27 Nov 2017
- Primary completion27 Feb 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant InflammationStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Nihal ERAYDIN, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730568
- Sponsor's protocol ID
- PI-RCT
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Non-surgical Treatment Approaches of Peri-implantitis: a Multi-arm Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06730568
- Acronym / sponsor ID
- PI-RCT
- Conditions
- Peri-implant Inflammation, Peri-Implantitis and Peri-implant Mucositis, Non-surgical Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 12 Dec 2024 (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-implantitis is a biofilm-associated pathological condition characterized by inflammation within the peri-implant mucosa, which leads to the progressive loss of the surrounding supporting bone tissue. The primary goal of managing peri-implantitis is to control the peri-implant biofilm and resolve inflammation. Nonsurgical treatment of peri-implantitis by submarginal mechanical instrumentation alone typically provides clinical improvements, particularly in non-advanced cases. However, to ensure surface decontamination and enhance treatment outcomes, alternative or adjunctive methods, such as systemic/local antibiotics, antiseptics, lasers, and air-abrasion systems, have been proposed.
Therefore, the null hypothesis (H0) of the present study is that no statistically significant difference would be detected in clinical inflammation signs among patients diagnosed with early-stage peri-implantitis after undergoing one of the following treatments: nonsurgical mechanical instrumentation alone, mechanical instrumentation plus chlorhexidine (CHX), mechanical instrumentation plus gaseous ozone, mechanical instrumentation plus glycine air polishing, or glycine air polishing alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mechanical Instrumentation (M) | Active comparator | Procedure: Submarginal mechanical instrumentationThe participants in the mechanical instrumentation (M) group were treated with conventional submarginal instrumentation using titanium curettes. |
| Mechanical Instrumentation with Chlorhexidine (MC) | Experimental | Procedure: Submarginal mechanical instrumentation and chlorhexidine irrigationParticipants in the mechanical instrumentation with chlorhexidine (MC) group were treated with conventional submarginal instrumentation using titanium curettes followed by adjunctive chlorhexidine irrigation. |
| Mechanical Instrumentation with Ozone (MO) | Experimental | Procedure: Submarginal mechanical instrumentation and ozone applicationParticipants in the mechanical instrumentation with chlorhexidine (MC) group were treated with conventional submarginal instrumentation using titanium curettes followed by gaseous ozone |
| Mechanical Instrumentation with Air Abrasion (MA) | Experimental | Procedure: Submarginal mechanical instrumentation and air abrasionThe participants in the mechanical instrumentation with glycine powder air abrasion (MA) group were treated with conventional submarginal instrumentation using titanium curettes and followed by adjunctive glycine air-abrasion. |
| Air Abrasion Monotherapy (A) | Experimental | Procedure: Air abrasion monotherapyThe participants in the air abrasion monotherapy (A) group were treated exclusively with glycine powder-based air abrasion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- the presence of at least one titanium implant with clinical and radiographic signs of initial to moderate peri-implantitis
- single-unit or partial restorations without overhangings
- absence of occlusal overload
- the presence of at least 2 mm of keratinized attached peri-implant mucosa
- periodontally healthy participants with a good level of oral hygiene
Key exclusion criteria (4 listed)
- the presence of implant mobility
- systemic diseases (i.e. diabetes (HbA1c <7), osteoporosis, bisphosphonate medication) which could affect the outcome of treatment
- smoking
- placement, and prosthetic loading of implants within the past year
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 |
|---|---|---|
| Submarginal mechanical instrumentationLocal anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. No adjunctive therapies were applied in this group. | Procedure or surgery | Mechanical Instrumentation (M) |
| Submarginal mechanical instrumentation and chlorhexidine irrigationThe participants in the mechanical instrumentation with chlorhexidine (MC) group were treated with conventional submarginal instrumentation using titanium curettes. Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. Following mechanical instrumentation, the peri-implant pockets were irrigated with 0.2% chlorhexidine digluconate solution for 1 minute. | Procedure or surgery | Mechanical Instrumentation with Chlorhexidine (MC) |
| Submarginal mechanical instrumentation and ozone applicationThe participants in the mechanical instrumentation with ozone (MO) group were treated with conventional submarginal instrumentation using titanium curettes. Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. Following mechanical instrumentation, gaseous ozone was applied to the peri-implant pockets using an ozone-generating device and a specialized glass fiber probe. The ozone gas was delivered to four sites (mesial, distal, buccal, and lingual) for 15 seconds per site, resulting in a total application time of 1 minute per implant. The device operated at a power of 3 watts and 80% oxygen concentration, as recommended by the manufacturer. | Procedure or surgery | Mechanical Instrumentation with Ozone (MO) |
| Submarginal mechanical instrumentation and air abrasionThe participants in the mechanical instrumentation with glycine powder air abrasion (MA) group were treated with conventional submarginal instrumentation using titanium curettes. Local anesthesia was applied before the procedure. The operator performed submarginal mechanical debridement until the implant surface was deemed adequately cleaned. Following mechanical instrumentation, the peri-implant pockets were treated with glycine powder-based air abrasion using an air-abrasion device (AIR-FLOW® handy 3.0 PERIO HANDPIECE, EMS, Nyon, Switzerland) and a flexible Perio-Flow® nozzle. The nozzle was inserted into the pockets and guided in a circular motion from coronal to apical, parallel to the implant surface, in a non-contact mode as recommended by the manufacturer. The air-abrasion treatment was applied to four sites (mesial, distal, buccal, and lingual) for 5 seconds per site, resulting in a total application time of 20 seconds per implant. | Procedure or surgery | Mechanical Instrumentation with Air Abrasion (MA) |
| Air abrasion monotherapyThe participants in the glycine powder air abrasion monotherapy (A) group were treated exclusively with glycine powder-based air abrasion. Local anesthesia was applied before the procedure. The peri-implant pockets were instrumented with an air-abrasion device using glycine powder and a flexible nozzle. The nozzle was inserted into the pockets and guided in a circular motion from coronal to apical, parallel to the implant surface, in a non-contact mode as recommended by the manufacturer. The air-abrasion treatment was applied to four sites (mesial, distal, buccal, and lingual) for 5 seconds per site, resulting in a total application time of 20 seconds per implant. . | Procedure or surgery | Air Abrasion Monotherapy (A) |
Primary outcome
Probable Pocket Depth
Time frame: Baseline, 3 months, and 6 months after treatment
2 secondary outcomes
Bleeding on Probing
Time frame: Baseline, 3 months, and 6 months after treatment
Plaque Index
Time frame: Baseline, 3 months, and 6 months after 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 12 Dec 2024.
- Individual participant dataSharing planned: No
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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 Submarginal mechanical instrumentation, Submarginal mechanical instrumentation and chlorhexidine irrigation and Submarginal mechanical instrumentation and ozone application in people with Peri-implant Inflammation and Peri-Implantitis and Peri-implant Mucositis, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 4 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 12 Dec 2024. 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 Turkey (Türkiye). 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?
Probable Pocket Depth (time frame: Baseline, 3 months, and 6 months after treatment). 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 12 Dec 2024.