PeriodontitisNCT03757260
Efficacy of Adjunctive Antimicrobial Photodynamic Therapy for Residual Pockets in Previously Surgically Treated Teeth
A study testing Antimicrobial photodynamic therapy in people with Periodontitis, run by University of Manitoba at 1 site in Canada.
Trial summary
Traditionally, periodontal gum surgery has been used as a method to gain access to inflamed periodontal pockets around teeth. The outcome of these surgeries, however, is not always successful as there can be recurrence of inflammation and disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Antimicrobial photodynamic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2019to Aug 2020
- 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
- Systemically healthy
- Enrolled in a supportive periodontal therapy program and a patient at the University of Manitoba Graduate Periodontics Clinic
- At least one surgically treated periodontal site with a residual pocket probing depth of ≥ 5mm and bleeding upon probing
- Completed informed consent
Who cannot join
- Patients with uncontrolled diabetes mellitus
- Patients with cancer
- Patients with HIV
- Patients with bone metabolic diseases
- Patients with disorders that compromise wound healing
- Patients undergoing radiation or immunosuppressive therapy
Show all 10Show fewer
- Pregnancy or lactation
- Have had antibiotics therapy within the last three months
- Confirmed or suspected intolerance to methylene blue
- Any physical limitations or restrictions that might preclude normal oral hygiene procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Adjunctive Antimicrobial Photodynamic Therapy for Residual Pockets in Previously Surgically Treated Teeth: a Randomized Clinical Trial.
Traditionally, periodontal gum surgery has been used as a method to gain access to inflamed periodontal pockets around teeth. The outcome of these surgeries, however, is not always successful as there can be recurrence of inflammation and disease. The objective of this study is to assess the effectiveness of antimicrobial photodynamic therapy as an adjunct to mechanical debridement of residual periodontal pockets in patients having undergone periodontal surgery. Pocket probing depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) will be evaluated at all sites as measures of inflammation and disease resolution.
Read the detailed description
A single-center, randomized, double-blind, longitudinal study will take place over 12 months. Twenty-eight systemically healthy patients (i.e. absence of uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases, or disorders that compromise wound healing) enrolled in a supportive periodontal therapy program and patients at the University of Manitoba Graduate Periodontics Clinic, with at least one surgically treated site with a residual pocket probing depth of ≥ 5mm and bleeding upon probing and having signed the informed consent will be accepted into the study. PPD, CAL, BOP, and PI will be evaluated at these sites. A selected participant will have a full mouth periodontal charting completed prior to baseline measurements as part of their maintenance program.
Once selected the patient will see two clinicians: the examiner (hygienist) and operator (resident).
The examiner records the data (PPD, CAL, BOP, PI) of the entire dentition including the selected tooth or teeth, and provides preliminary hygiene treatment; the operator delivers the test treatments.
The treatment assignments are concealed to the patient and the examiner. The operator is unaware of previously recorded data except for pocket depth measurements and is not involved in the post-treatment evaluations (3,6,12 months). At 12 months, a full mouth re-evaluation will be completed by the examiner as part of the patient's maintenance program.
In the first visit, the examiner records the pocket probing depth, clinical attachment level, presence of bleeding on probing, and plaque index at six sites on involved teeth. Thorough scaling and root planing is performed under local anesthesia using periodontal curettes (Gracey, Hu-Friedy, USA) and an ultrasonic device (Piezo, Ultradent, USA). Once complete, the operator takes over. The patients are then randomly assigned to test or control groups by a computer-generated table. The protocol may be: A, the laser is activated during treatments with methylene blue; B, the laser is never activated during treatments with saline solution.
Antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system (Ondine Biomedical Inc, Vancouver, Canada). The photosensitizing agent is methylene blue. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is illuminated for 60 seconds to activate the agent using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power). The control treatment consists of the same procedure, except that the photosensitizer is replaced with saline solution and the light-diffusing tip is kept in the pocket for 60 seconds without activating the laser. The patient is sent home with a home care package and oral hygiene instructions.
The second session is scheduled after 1 week. The operator applies the photosensitizer and activates the laser according to protocol A or B. The examiner maintains the patients on a 3-month hygiene schedule and reassesses the participants 3, 6, and 12 months after the treatment as well as reinforces oral hygiene instruction. Medical history, concomitant medication, and all adverse events are recorded. Clinical parameters are measured the same way as at baseline. All measurements will be calibrated.
- Conditions
- Periodontitis
- Being tested
- Antimicrobial photodynamic therapy, Placebo of photodynamic therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial photodynamic therapyDevice
Also called "Periowave" trade name
Antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is methylene blue. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is illuminated for 60 seconds to activate the agent using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).
Placebo of photodynamic therapyDevice
Also called Placebo of "Periowave" trade name
The placebo of the antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is saline solution. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is not illuminated (falsely activated) for 60 seconds using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Antimicrobial photodynamic therapy with methylene blue applied to test site after mechanical debridement. Receives: Device: Antimicrobial photodynamic therapy |
| Placebo Group | Placebo comparator | Photodynamic therapy laser is not activated with saline water in the test site after mechanical debridement. Receives: Device: Placebo of photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bleeding on probing (BOP)
Change in the presence of bleeding upon probing on individual tooth surfaces at 3 months, 6 months, and 12 months compared to the initial measure.
Measured: Initial, 3 months, 6 months, 12 months.
Secondary outcomes (3)
Change in pocket probing depth (PPD)
Change of the distance from the gingival margin to the tip of the periodontal probe at the bottom of the gingival pocket at 3 months, 6 months, and 12 months compared to the initial measure.
Measured: Initial, 3 months, 6 months, 12 months.
Change of clinical attachment level (CAL)
Change of the distance from the cemento-enamel junction to the tip of the periodontal probe at the bottom of the gingival pocket at 3 months, 6 months, and 12 months compared to the initial measure.
Measured: Initial, 3 months, 6 months, 12 months.
Change of plaque index (PI)
Change in the presence of plaque on individual tooth surfaces at 3 months, 6 months, and 12 months compared to the initial measure.
Measured: Initial, 3 months, 6 months, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start8 Jan 2019
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Cabrales, University of Manitoba
- Investigators
- Anastasia Cholakis, M Dent, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757260
- Sponsor's protocol ID
- B2018:012
- Status last verified
- Sep 2019
- First submitted
- 23 Nov 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be made available in an anonymized (de-identified) form.
Publications
Van der Weijden GA, Timmerman MF. A systematic review on the clinical efficacy of subgingival debridement in the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:55-71; discussion 90-1. doi: 10.1034/j.1600-051x.29.s3.3.x.
PubMed 12787207Greenstein G. Periodontal response to mechanical non-surgical therapy: a review. J Periodontol. 1992 Feb;63(2):118-30. doi: 10.1902/jop.1992.63.2.118.
PubMed 1552465Caffesse RG, Sweeney PL, Smith BA. Scaling and root planing with and without periodontal flap surgery. J Clin Periodontol. 1986 Mar;13(3):205-10. doi: 10.1111/j.1600-051x.1986.tb01461.x.
PubMed 3517073Serino G, Rosling B, Ramberg P, Socransky SS, Lindhe J. Initial outcome and long-term effect of surgical and non-surgical treatment of advanced periodontal disease. J Clin Periodontol. 2001 Oct;28(10):910-6. doi: 10.1034/j.1600-051x.2001.028010910.x.
PubMed 11686808Mombelli A, Schmid B, Rutar A, Lang NP. Persistence patterns of Porphyromonas gingivalis, Prevotella intermedia/nigrescens, and Actinobacillus actinomyetemcomitans after mechanical therapy of periodontal disease. J Periodontol. 2000 Jan;71(1):14-21. doi: 10.1902/jop.2000.71.1.14.
PubMed 10695934Magnusson I, Lindhe J, Yoneyama T, Liljenberg B. Recolonization of a subgingival microbiota following scaling in deep pockets. J Clin Periodontol. 1984 Mar;11(3):193-207. doi: 10.1111/j.1600-051x.1984.tb01323.x.
PubMed 6368611Quirynen M, Bollen CM, Vandekerckhove BN, Dekeyser C, Papaioannou W, Eyssen H. Full- vs. partial-mouth disinfection in the treatment of periodontal infections: short-term clinical and microbiological observations. J Dent Res. 1995 Aug;74(8):1459-67. doi: 10.1177/00220345950740080501.
PubMed 7560400Sbordone L, Ramaglia L, Gulletta E, Iacono V. Recolonization of the subgingival microflora after scaling and root planing in human periodontitis. J Periodontol. 1990 Sep;61(9):579-84. doi: 10.1902/jop.1990.61.9.579.
PubMed 2213468Adriaens PA, Edwards CA, De Boever JA, Loesche WJ. Ultrastructural observations on bacterial invasion in cementum and radicular dentin of periodontally diseased human teeth. J Periodontol. 1988 Aug;59(8):493-503. doi: 10.1902/jop.1988.59.8.493.
PubMed 3171862Kocher T, Fanghanel J, Sawaf H, Litz R. Substance loss caused by scaling with different sonic scaler inserts--an in vitro study. J Clin Periodontol. 2001 Jan;28(1):9-15. doi: 10.1034/j.1600-051x.2001.280102.x.
PubMed 11142673Flemmig TF, Petersilka GJ, Mehl A, Hickel R, Klaiber B. The effect of working parameters on root substance removal using a piezoelectric ultrasonic scaler in vitro. J Clin Periodontol. 1998 Feb;25(2):158-63. doi: 10.1111/j.1600-051x.1998.tb02422.x.
PubMed 9495615Ritz L, Hefti AF, Rateitschak KH. An in vitro investigation on the loss of root substance in scaling with various instruments. J Clin Periodontol. 1991 Oct;18(9):643-7. doi: 10.1111/j.1600-051x.1991.tb00104.x.
PubMed 1960232Zappa U, Smith B, Simona C, Graf H, Case D, Kim W. Root substance removal by scaling and root planing. J Periodontol. 1991 Dec;62(12):750-4. doi: 10.1902/jop.1991.62.12.750.
PubMed 1765938Badersten A, Nilveus R, Egelberg J. Effect of nonsurgical periodontal therapy. I. Moderately advanced periodontitis. J Clin Periodontol. 1981 Feb;8(1):57-72. doi: 10.1111/j.1600-051x.1981.tb02024.x.
PubMed 6972954Badersten A, Nilveus R, Egelberg J. Effect of nonsurgical periodontal therapy. II. Severely advanced periodontitis. J Clin Periodontol. 1984 Jan;11(1):63-76. doi: 10.1111/j.1600-051x.1984.tb01309.x.
PubMed 6363463
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adjunctive Antimicrobial Photodynamic Therapy for Residual Pockets in Previously Surgically Treated Teeth: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03757260
- Acronym / sponsor ID
- B2018:012
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 28 Nov 2018 (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.
Traditionally, periodontal gum surgery has been used as a method to gain access to inflamed periodontal pockets around teeth. The outcome of these surgeries, however, is not always successful as there can be recurrence of inflammation and disease. The objective of this study is to assess the effectiveness of antimicrobial photodynamic therapy as an adjunct to mechanical debridement of residual periodontal pockets in patients having undergone periodontal surgery. Pocket probing depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) will be evaluated at all sites as measures of inflammation and disease resolution.
Detailed description
A single-center, randomized, double-blind, longitudinal study will take place over 12 months. Twenty-eight systemically healthy patients (i.e. absence of uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases, or disorders that compromise wound healing) enrolled in a supportive periodontal therapy program and patients at the University of Manitoba Graduate Periodontics Clinic, with at least one surgically treated site with a residual pocket probing depth of ≥ 5mm and bleeding upon probing and having signed the informed consent will be accepted into the study. PPD, CAL, BOP, and PI will be evaluated at these sites. A selected participant will have a full mouth periodontal charting completed prior to baseline measurements as part of their maintenance program.
Once selected the patient will see two clinicians: the examiner (hygienist) and operator (resident).
The examiner records the data (PPD, CAL, BOP, PI) of the entire dentition including the selected tooth or teeth, and provides preliminary hygiene treatment; the operator delivers the test treatments.
The treatment assignments are concealed to the patient and the examiner. The operator is unaware of previously recorded data except for pocket depth measurements and is not involved in the post-treatment evaluations (3,6,12 months). At 12 months, a full mouth re-evaluation will be completed by the examiner as part of the patient's maintenance program.
In the first visit, the examiner records the pocket probing depth, clinical attachment level, presence of bleeding on probing, and plaque index at six sites on involved teeth. Thorough scaling and root planing is performed under local anesthesia using periodontal curettes (Gracey, Hu-Friedy, USA) and an ultrasonic device (Piezo, Ultradent, USA). Once complete, the operator takes over. The patients are then randomly assigned to test or control groups by a computer-generated table. The protocol may be: A, the laser is activated during treatments with methylene blue; B, the laser is never activated during treatments with saline solution.
Antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system (Ondine Biomedical Inc, Vancouver, Canada). The photosensitizing agent is methylene blue. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is illuminated for 60 seconds to activate the agent using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power). The control treatment consists of the same procedure, except that the photosensitizer is replaced with saline solution and the light-diffusing tip is kept in the pocket for 60 seconds without activating the laser. The patient is sent home with a home care package and oral hygiene instructions.
The second session is scheduled after 1 week. The operator applies the photosensitizer and activates the laser according to protocol A or B. The examiner maintains the patients on a 3-month hygiene schedule and reassesses the participants 3, 6, and 12 months after the treatment as well as reinforces oral hygiene instruction. Medical history, concomitant medication, and all adverse events are recorded. Clinical parameters are measured the same way as at baseline. All measurements will be calibrated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Antimicrobial photodynamic therapyAntimicrobial photodynamic therapy with methylene blue applied to test site after mechanical debridement. |
| Placebo Group | Placebo comparator | Device: Placebo of photodynamic therapyPhotodynamic therapy laser is not activated with saline water in the test site after mechanical debridement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Systemically healthy
- Enrolled in a supportive periodontal therapy program and a patient at the University of Manitoba Graduate Periodontics Clinic
- At least one surgically treated periodontal site with a residual pocket probing depth of ≥ 5mm and bleeding upon probing
- Completed informed consent
Key exclusion criteria (10 listed)
- Patients with uncontrolled diabetes mellitus
- Patients with cancer
- Patients with HIV
- Patients with bone metabolic diseases
- Patients with disorders that compromise wound healing
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 |
|---|---|---|
| Antimicrobial photodynamic therapyAlso: "Periowave" trade nameAntimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is methylene blue. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is illuminated for 60 seconds to activate the agent using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power). | Device | Treatment Group |
| Placebo of photodynamic therapyAlso: Placebo of "Periowave" trade nameThe placebo of the antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is saline solution. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is not illuminated (falsely activated) for 60 seconds using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power). | Device | Placebo Group |
Primary outcome
Change in bleeding on probing (BOP)
Time frame: Initial, 3 months, 6 months, 12 months.
Change in the presence of bleeding upon probing on individual tooth surfaces at 3 months, 6 months, and 12 months compared to the initial measure.
3 secondary outcomes
Change in pocket probing depth (PPD)
Time frame: Initial, 3 months, 6 months, 12 months.
Change of clinical attachment level (CAL)
Time frame: Initial, 3 months, 6 months, 12 months.
Change of plaque index (PI)
Time frame: Initial, 3 months, 6 months, 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Background: PubMed 12787207Van der Weijden GA, Timmerman MF. A systematic review on the clinical efficacy of subgingival debridement in the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:55-71; discussion 90-1. doi: 10.1034/j.1600-051x.29.s3.3.x.
- Background: PubMed 1552465Greenstein G. Periodontal response to mechanical non-surgical therapy: a review. J Periodontol. 1992 Feb;63(2):118-30. doi: 10.1902/jop.1992.63.2.118.
- Background: PubMed 3517073Caffesse RG, Sweeney PL, Smith BA. Scaling and root planing with and without periodontal flap surgery. J Clin Periodontol. 1986 Mar;13(3):205-10. doi: 10.1111/j.1600-051x.1986.tb01461.x.
- Background: PubMed 11686808Serino G, Rosling B, Ramberg P, Socransky SS, Lindhe J. Initial outcome and long-term effect of surgical and non-surgical treatment of advanced periodontal disease. J Clin Periodontol. 2001 Oct;28(10):910-6. doi: 10.1034/j.1600-051x.2001.028010910.x.
- Background: PubMed 10695934Mombelli A, Schmid B, Rutar A, Lang NP. Persistence patterns of Porphyromonas gingivalis, Prevotella intermedia/nigrescens, and Actinobacillus actinomyetemcomitans after mechanical therapy of periodontal disease. J Periodontol. 2000 Jan;71(1):14-21. doi: 10.1902/jop.2000.71.1.14.
- Background: PubMed 6368611Magnusson I, Lindhe J, Yoneyama T, Liljenberg B. Recolonization of a subgingival microbiota following scaling in deep pockets. J Clin Periodontol. 1984 Mar;11(3):193-207. doi: 10.1111/j.1600-051x.1984.tb01323.x.
- Background: PubMed 7560400Quirynen M, Bollen CM, Vandekerckhove BN, Dekeyser C, Papaioannou W, Eyssen H. Full- vs. partial-mouth disinfection in the treatment of periodontal infections: short-term clinical and microbiological observations. J Dent Res. 1995 Aug;74(8):1459-67. doi: 10.1177/00220345950740080501.
- Background: PubMed 2213468Sbordone L, Ramaglia L, Gulletta E, Iacono V. Recolonization of the subgingival microflora after scaling and root planing in human periodontitis. J Periodontol. 1990 Sep;61(9):579-84. doi: 10.1902/jop.1990.61.9.579.
- Background: PubMed 3171862Adriaens PA, Edwards CA, De Boever JA, Loesche WJ. Ultrastructural observations on bacterial invasion in cementum and radicular dentin of periodontally diseased human teeth. J Periodontol. 1988 Aug;59(8):493-503. doi: 10.1902/jop.1988.59.8.493.
- Background: PubMed 11142673Kocher T, Fanghanel J, Sawaf H, Litz R. Substance loss caused by scaling with different sonic scaler inserts--an in vitro study. J Clin Periodontol. 2001 Jan;28(1):9-15. doi: 10.1034/j.1600-051x.2001.280102.x.
- Background: PubMed 9495615Flemmig TF, Petersilka GJ, Mehl A, Hickel R, Klaiber B. The effect of working parameters on root substance removal using a piezoelectric ultrasonic scaler in vitro. J Clin Periodontol. 1998 Feb;25(2):158-63. doi: 10.1111/j.1600-051x.1998.tb02422.x.
- Background: PubMed 1960232Ritz L, Hefti AF, Rateitschak KH. An in vitro investigation on the loss of root substance in scaling with various instruments. J Clin Periodontol. 1991 Oct;18(9):643-7. doi: 10.1111/j.1600-051x.1991.tb00104.x.
- Individual participant dataSharing planned: Yes. All IPD will be made available in an anonymized (de-identified) form.
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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.
Anastasia Cholakis, M Dent study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial photodynamic therapy in people with Periodontitis, run by University of Manitoba at 1 site in Canada.
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 10 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: status not confirmed, as of the sponsor's last update on 1 Oct 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 in bleeding on probing (BOP) (time frame: Initial, 3 months, 6 months, 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03757260, which also lists 37 linked publications.
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 1 Oct 2019.