Peri-implantitisNCT03114956
Surface Decontamination in Treatment of Peri-Implantitis
A study testing Gauze, Titanium brush and Air powder abrasion in people with Peri-implantitis, run by University of Southern California.
Trial summary
Peri-implantitis represents a major biological complication of implant dentistry with reported prevalence of up to 47% of implants. The disease is characterized by inflammatory response to the biofilm inhabiting the implant surface. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Gauze, Titanium brush and Air powder abrasion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Jun 2019to 19 Jun 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PPD >6 mm
- Positive BOP
- Peri-implant marginal bone loss (MBL) >3 mm
- Age: 18 to 75 years
Who cannot join
- Implant mobility
- Smoking
- Current cancer
- Steroids use (last 2 years)
- Bisphosphonates use (last 4 years)
- Uncontrolled diabetes (HBA1c >7)
- Other systemic conditions that affect wound healing
About this study
Official title: Effects of Implant Surface Decontamination on Control of Peri-Implant Inflammation
Peri-implantitis represents a major biological complication of implant dentistry with reported prevalence of up to 47% of implants. The disease is characterized by inflammatory response to the biofilm inhabiting the implant surface. To treat this inflammatory disease, surgical and non-surgical therapies have been proposed, all of which entail biofilm removal through implant surface decontamination. Systematic review of various surface decontamination protocols has failed to demonstrate superiority of any of the protocols. One possible explanation is that most studies have examined decontamination of implant surfaces following experimentally-induced peri-implantitis, where implant surfaces lack the tenacious mineralized biofilm often found in clinical peri-implantitis and are therefore easily decontaminated.
The investigators have hypothesized that control of inflammation and repair of pathologically damaged peri-implant tissues requires a comprehensive mechanical plus chemical surface decontamination therapy. The aims of this study are to 1) determine the most effective surface decontamination protocol that can lead to control of peri-implant inflammation and 2) delineate the microbial and immunological mediators that are associated with the changes in peri-implant inflammation. The investigators propose to compare conventional implant surface contamination techniques to a comprehensive mechanical plus chemical protocol. This randomized controlled clinical trial seeks to enroll 68 participants with at least one implant diagnosed with moderate to severe peri-implantitis. Pre-op parameters to be assessed include: probing pocket depth, bleeding on probing, suppuration, plaque index, marginal inflammation, recession, clinical attachment level, inflammatory biomarkers and microbial sampling, and digital intra-oral peri-apical radiograph. Subjects will be randomly assigned to one of the four surgical debridement intervention groups: (A) gauzes soaked in sterile saline and chlorhexidine; (B) Titanium brush; (C) Air power abrasion; (D) comprehensive surface decontamination, including titanium brush, air powder abrasion and surface etching with 9.6% hydrofluoric acid gel. At 3-months post-operative, the initial clinical assessment will be repeated. The clinical examination will be used to analyze the efficacy of each treatment in controlling peri-implant mucosal inflammation. The ultimate objective of this research is not only to identify an effective method for control of peri-implant inflammation, but also to lay the foundation to detect biomarkers of peri-implantitis that can potentially be helpful in future studies as risk factors of this disease.
- Conditions
- Peri-implantitis
- Being tested
- Gauze, Titanium brush, Air powder abrasion, Comprehensive
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GauzeProcedure or surgery
Implant surface will be wiped with sterile gauze soaked alternatively in sterile saline and CHX (5 times)
Titanium brushProcedure or surgery
Titanium brush: Titanium brush (TiBrush, Straumann, Switzerland) mounted on an oscillating hand piece will be used for 1 minute.
Air powder abrasionProcedure or surgery
Air powder abrasion: One minute of air powder abrasion using Glycine prophy powder (Prophy Jet, Dentsply, USA) with overlapping passes form apical to coronal direction for 1 minute.
ComprehensiveProcedure or surgery
A comprehensive treatment including the use of titanium brush and air powder abrasion (as described above) and 30 seconds etching with 9.6% HF acid gel (Premier, USA) applied with a micro-applicator tip (Unipack Medical, USA), followed by copious irrigation with sterile saline.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Implant surface will be wiped with sterile gauze soaked alternatively in sterile saline and CHX (5 times) Receives: Procedure: Gauze |
| Group B | Experimental | Titanium brush: Titanium brush (TiBrush, Straumann, Switzerland) mounted on an oscillating hand piece will be used for 1 minute. Receives: Procedure: Titanium brush |
| Group C | Experimental | Air powder abrasion: One minute of air powder abrasion using Glycine prophy powder (Prophy Jet, Dentsply, USA) with overlapping passes form apical to coronal direction for 1 minute. Receives: Procedure: Air powder abrasion |
| Group D | Experimental | A comprehensive treatment including the use of titanium brush and air powder abrasion (as described above) and 30 seconds etching with 9.6% HF acid gel (Premier, USA) applied with a micro-applicator tip (Unipack Medical, USA), followed by copious irrigation with sterile saline. Receives: Procedure: Comprehensive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing (BOP)
A periodontal probe will be used at 6 locations around each implant (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual). Presence of gingival bleeding upon probing will be recorded. This will be a binary outcome (Yes or No)
Measured: 3 months
Suppuration upon probing
A periodontal probe will be used at 6 locations around each implant (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual). Presence of suppuration upon probing will be recorded. This will be a binary outcome (Yes or No)
Measured: 3 months
Probing Pocket Depth (PPD)
Distance from the gingival margin to the depth of the pocket
Measured: 3 months
Secondary outcomes (3)
Marginal bone loss
Measurement from the implant platform to first bone-to-implant contact
Measured: 3 month
Inflammatory biomarkers
Inflammatory biomarkers in the peri-implant crevicular fluid (PICF)
Measured: 3 months
Microbial profile
Microbial profile in the peri-implant crevicular fluid (PICF)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start19 Jun 2019
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Why it stopped: Not able to secure funding
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.
- More trials run by University of Southern CaliforniaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neema Bakhshalian, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114956
- Sponsor's protocol ID
- 15-188
- Status last verified
- Jun 2019
- First submitted
- 3 Apr 2017
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, the clinical data and radiographs will be shared with other investigators included in this study for analysis.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Implant Surface Decontamination on Control of Peri-Implant Inflammation
- ClinicalTrials.gov ID
- NCT03114956
- Acronym / sponsor ID
- 15-188
- Conditions
- Peri-implantitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to secure funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 14 Apr 2017 (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 represents a major biological complication of implant dentistry with reported prevalence of up to 47% of implants. The disease is characterized by inflammatory response to the biofilm inhabiting the implant surface. To treat this inflammatory disease, surgical and non-surgical therapies have been proposed, all of which entail biofilm removal through implant surface decontamination. Systematic review of various surface decontamination protocols has failed to demonstrate superiority of any of the protocols. One possible explanation is that most studies have examined decontamination of implant surfaces following experimentally-induced peri-implantitis, where implant surfaces lack the tenacious mineralized biofilm often found in clinical peri-implantitis and are therefore easily decontaminated.
The investigators have hypothesized that control of inflammation and repair of pathologically damaged peri-implant tissues requires a comprehensive mechanical plus chemical surface decontamination therapy. The aims of this study are to 1) determine the most effective surface decontamination protocol that can lead to control of peri-implant inflammation and 2) delineate the microbial and immunological mediators that are associated with the changes in peri-implant inflammation. The investigators propose to compare conventional implant surface contamination techniques to a comprehensive mechanical plus chemical protocol. This randomized controlled clinical trial seeks to enroll 68 participants with at least one implant diagnosed with moderate to severe peri-implantitis. Pre-op parameters to be assessed include: probing pocket depth, bleeding on probing, suppuration, plaque index, marginal inflammation, recession, clinical attachment level, inflammatory biomarkers and microbial sampling, and digital intra-oral peri-apical radiograph. Subjects will be randomly assigned to one of the four surgical debridement intervention groups: (A) gauzes soaked in sterile saline and chlorhexidine; (B) Titanium brush; (C) Air power abrasion; (D) comprehensive surface decontamination, including titanium brush, air powder abrasion and surface etching with 9.6% hydrofluoric acid gel. At 3-months post-operative, the initial clinical assessment will be repeated. The clinical examination will be used to analyze the efficacy of each treatment in controlling peri-implant mucosal inflammation. The ultimate objective of this research is not only to identify an effective method for control of peri-implant inflammation, but also to lay the foundation to detect biomarkers of peri-implantitis that can potentially be helpful in future studies as risk factors of this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: GauzeImplant surface will be wiped with sterile gauze soaked alternatively in sterile saline and CHX (5 times) |
| Group B | Experimental | Procedure: Titanium brushTitanium brush: Titanium brush (TiBrush, Straumann, Switzerland) mounted on an oscillating hand piece will be used for 1 minute. |
| Group C | Experimental | Procedure: Air powder abrasionAir powder abrasion: One minute of air powder abrasion using Glycine prophy powder (Prophy Jet, Dentsply, USA) with overlapping passes form apical to coronal direction for 1 minute. |
| Group D | Experimental | Procedure: ComprehensiveA comprehensive treatment including the use of titanium brush and air powder abrasion (as described above) and 30 seconds etching with 9.6% HF acid gel (Premier, USA) applied with a micro-applicator tip (Unipack Medical, USA), followed by copious irrigation with sterile saline. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PPD >6 mm
- Positive BOP
- Peri-implant marginal bone loss (MBL) >3 mm
- Age: 18 to 75 years
Key exclusion criteria (7 listed)
- Implant mobility
- Smoking
- Current cancer
- Steroids use (last 2 years)
- Bisphosphonates use (last 4 years)
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 |
|---|---|---|
| GauzeImplant surface will be wiped with sterile gauze soaked alternatively in sterile saline and CHX (5 times) | Procedure or surgery | Group A |
| Titanium brushTitanium brush: Titanium brush (TiBrush, Straumann, Switzerland) mounted on an oscillating hand piece will be used for 1 minute. | Procedure or surgery | Group B |
| Air powder abrasionAir powder abrasion: One minute of air powder abrasion using Glycine prophy powder (Prophy Jet, Dentsply, USA) with overlapping passes form apical to coronal direction for 1 minute. | Procedure or surgery | Group C |
| ComprehensiveA comprehensive treatment including the use of titanium brush and air powder abrasion (as described above) and 30 seconds etching with 9.6% HF acid gel (Premier, USA) applied with a micro-applicator tip (Unipack Medical, USA), followed by copious irrigation with sterile saline. | Procedure or surgery | Group D |
Primary outcome
Bleeding on Probing (BOP)
Time frame: 3 months
A periodontal probe will be used at 6 locations around each implant (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual). Presence of gingival bleeding upon probing will be recorded. This will be a binary outcome (Yes or No)
Suppuration upon probing
Time frame: 3 months
A periodontal probe will be used at 6 locations around each implant (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual). Presence of suppuration upon probing will be recorded. This will be a binary outcome (Yes or No)
Probing Pocket Depth (PPD)
Time frame: 3 months
Distance from the gingival margin to the depth of the pocket
3 secondary outcomes
Marginal bone loss
Time frame: 3 month
Inflammatory biomarkers
Time frame: 3 months
Microbial profile
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Individual participant dataSharing planned: Yes. At the end of the study, the clinical data and radiographs will be shared with other investigators included in this study for analysis.
Related trials for Peri-implantitis
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
RecruitingObservational study
Access to Probing and Peri-implant Diseases
Peri-implantitis, Peri-implant Bone Loss
Not yet recruitingObservational study
ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
Peri-Implantitis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Gauze, Titanium brush and Air powder abrasion in people with Peri-implantitis, run by University of Southern California.
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 7 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: withdrawn, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 on Probing (BOP) (time frame: 3 months). 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?
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 21 Jun 2019.