Peri-implantitisPhase 3NCT02848482
Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic Therapy on Initial Peri-implantitis
A Phase 3 study testing Photodynamic therapy, Mechanical debridement and Irrigation in people with Peri-implantitis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated by exposure to light of a specific wavelength in the presence of oxygen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Photodynamic therapy, Mechanical debridement and Irrigation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 May 2019
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, ages over 18.
- Subjects with at least one implant with initial peri-implantitis: PPD of 4-6mm combined with BOP+, bone loss of 0.5-2mm on peri-apical radiographs compared to the time point of restoration placement.
- Availability for the 12 month duration of the study.
- Good general health (ASA classification I-II).
- Signed Informed Consent Form.
Who cannot join
- Medically compromised subjects (ASA classification III-V)
- Pregnant or lactating females.
- Peri-implant mucositis defined as the absence of radiographic marginal bone loss between restoration placement and pre-screening review.
- Subjects treated for >2 weeks with any medication known to affect soft tissue condition (e.g. phenytoin, calcium antagonists, cyclosporin, Coumadin and non-steroidal anti-inflammatory drugs) within 1 month of the baseline examination.
- Unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic
Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated by exposure to light of a specific wavelength in the presence of oxygen. In recent years, PDT has been introduced as an important novel disinfection therapy in the field of implant dentistry. The inactivation of microorganisms using PDT has been defined as antimicrobial PDT. PDT has the potential to be an alternative of antibiotics, especially for the treatment of localized infections and oral biofilm. PDT is unlikely to cause bacterial-resistance and is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria.
Inconsistent results have been reported regarding the potential role of PDT as an adjunct to mechanical debridement in the management of peri-implant infection. Thus, the aim of the present trial is to investigate the treatment effect of non-surgical treatment with and without photodynamic therapy on initial peri-implantitis.
- Conditions
- Peri-implantitis
- Being tested
- Photodynamic therapy, Mechanical debridement, Irrigation
- Keywords
- Photodynamic therapy
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyDevice
Photodynamic therapy (HELBO Photodynaimc Systems GmbH, Wels, Austria)
Mechanical debridementProcedure or surgery
Plastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites.
IrrigationDrug
0.2% chlorhexidine digluconate solution (Bioworld, Madision, US) will be irrigated at contaminated sites for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Plastic curette will be used to perform the mechanical debridement. Then, irrigation (2% chlorhexidine) will be performed at contaminated sites. Receives: Procedure: Mechanical debridement; Drug: Irrigation |
| Test group | Experimental | Plastic curette will be used to perform the mechanical debridement. Then, the addition photodynamic therapy (PDT) will be performed. This will be performed with a set-up for PDT (HELBO Photodynamic Systems, German). Receives: Device: Photodynamic therapy; Procedure: Mechanical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of percentage of bleeding on probing sites
A PQW Williams probe (Hu-Friedy, Chicago Ill, USA)will be used to detect the peri-implant pocket. the percentage of bleeding on probing sites (BOP) will be recorded.
Measured: From baseline to 12 months after treatment
Secondary outcomes (5)
Change of Probing Pocket Depth
Probing Pocket Depth at every site will be assessed as the distance from the gingival margin to the apical end of the pocket using a PQW Williams probe (Hu-Friedy, Chicago Ill, USA).
Measured: From baseline to 12 months after treatment
Change of modified plaque index
Modified plaque index 0= No detection of plaque.
- Plaque only recognized by running a probe across the smooth marginal surface of the implant. Implants covered by titanium spray in this area always score 1.
- Plaque can be seen by the naked eye.
- Abundance of soft matter.
Measured: From baseline to 12 months after treatment
Change of clinical attachment level
Measured: From baseline to 12 months after treatment
Marginal bone loss
Periapical radiographs will be taken at baseline, 3, 6, 9 and 12 month examination. The distance from implant shoulder to the most coronal level of implant-bone contact at the mesial and distal site will be recorded. The alteration of the distance between baseline and follow-up visit will be defined as marginal bone loss.
Measured: From baseline to 12 months after treatment
Mucosa recession
The distance from mucosa margin to the implant shoulder will be recorded using a PQW Williams probe (Hu-Friedy, Chicago Ill, USA). The alteration of the distance between baseline and follow-up visit will be defined as the mucosa recession.
Measured: From baseline to 12 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 posted28 Jul 2016 (estimated)
- Study start1 May 2017
- Primary completion1 May 2019
- Study completion1 May 2019
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 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848482
- Sponsor's protocol ID
- 1036_2016
- Status last verified
- May 2019
- First submitted
- 21 Jul 2016
- Last updated
- 16 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic
- ClinicalTrials.gov ID
- NCT02848482
- Acronym / sponsor ID
- 1036_2016
- Conditions
- Peri-implantitis
- Keywords
- Photodynamic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated by exposure to light of a specific wavelength in the presence of oxygen. In recent years, PDT has been introduced as an important novel disinfection therapy in the field of implant dentistry. The inactivation of microorganisms using PDT has been defined as antimicrobial PDT. PDT has the potential to be an alternative of antibiotics, especially for the treatment of localized infections and oral biofilm. PDT is unlikely to cause bacterial-resistance and is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria.
Inconsistent results have been reported regarding the potential role of PDT as an adjunct to mechanical debridement in the management of peri-implant infection. Thus, the aim of the present trial is to investigate the treatment effect of non-surgical treatment with and without photodynamic therapy on initial peri-implantitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Mechanical debridement, Drug: IrrigationPlastic curette will be used to perform the mechanical debridement. Then, irrigation (2% chlorhexidine) will be performed at contaminated sites. |
| Test group | Experimental | Device: Photodynamic therapy, Procedure: Mechanical debridementPlastic curette will be used to perform the mechanical debridement. Then, the addition photodynamic therapy (PDT) will be performed. This will be performed with a set-up for PDT (HELBO Photodynamic Systems, German). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects, ages over 18.
- Subjects with at least one implant with initial peri-implantitis: PPD of 4-6mm combined with BOP+, bone loss of 0.5-2mm on peri-apical radiographs compared to the time point of restoration placement.
- Availability for the 12 month duration of the study.
- Good general health (ASA classification I-II).
- Signed Informed Consent Form.
Key exclusion criteria (5 listed)
- Medically compromised subjects (ASA classification III-V)
- Pregnant or lactating females.
- Peri-implant mucositis defined as the absence of radiographic marginal bone loss between restoration placement and pre-screening review.
- Subjects treated for >2 weeks with any medication known to affect soft tissue condition (e.g. phenytoin, calcium antagonists, cyclosporin, Coumadin and non-steroidal anti-inflammatory drugs) within 1 month of the baseline examination.
- Unwilling to participate in the study.
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 |
|---|---|---|
| Photodynamic therapyPhotodynamic therapy (HELBO Photodynaimc Systems GmbH, Wels, Austria) | Device | Test group |
| Mechanical debridementPlastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites. | Procedure or surgery | Control group, Test group |
| Irrigation0.2% chlorhexidine digluconate solution (Bioworld, Madision, US) will be irrigated at contaminated sites for 1 minute. | Drug | Control group |
Primary outcome
Change of percentage of bleeding on probing sites
Time frame: From baseline to 12 months after treatment
A PQW Williams probe (Hu-Friedy, Chicago Ill, USA)will be used to detect the peri-implant pocket. the percentage of bleeding on probing sites (BOP) will be recorded.
5 secondary outcomes
Change of Probing Pocket Depth
Time frame: From baseline to 12 months after treatment
Change of modified plaque index
Time frame: From baseline to 12 months after treatment
Change of clinical attachment level
Time frame: From baseline to 12 months after treatment
Marginal bone loss
Time frame: From baseline to 12 months after treatment
Mucosa recession
Time frame: From baseline to 12 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 16 May 2019.
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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 Phase 3 study testing Photodynamic therapy, Mechanical debridement and Irrigation in people with Peri-implantitis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 16 May 2019. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of percentage of bleeding on probing sites (time frame: From baseline to 12 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 16 May 2019.