Peri-ImplantitisPhase 4NCT03564301
Metronidazole as an Adjunct of Non- Surgical Treatment of Peri-implantitis
A Phase 4 study testing Metronidazole 250 MG in people with Peri-Implantitis, run by Juan Blanco Carrión at 1 site in Spain.
Trial summary
The use of systemic antibiotics as and adjunct to non-surgical peri-implant therapy may be an improvement in comparison to these therapies alone. The primary objective is the evaluation of significant changes in probing pocket depth between non-surgical with or without antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Metronidazole 250 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2018to 22 Dec 2020
- Phase
- Phase 4
- 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
- Older than 18 years.
- Presence of at least 1 implant diagnosed with peri-implantitis (Presence of BOP and/or suppuration, with 2 mm of detectable bone loss after initial remodeling, and PD≥ 4 mm as defined by Daubert et al. 2015).
- Absence of implant mobility.
- History of taking systemic antibiotics in the preceding 3 months.
- No systemic pathology that contraindicated the completion of treatment.
- The patient understands the treatment and willing to comply.
- The patient is willing to give written informed consent and can do
Who cannot join
- Pregnant.
- Metronidazole allergies
- Patients on treatment with bisphosphonates.
- Uncontrolled periodontal disease.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of periodontology, faculty of Odontology
Santiago de Compostela, Coruña, 15782
About this study
Official title: Metronidazole as an Adjunct of Non- Surgical Treatment of Peri-implantitis : a 6-months Placebo- Controlled Clinical Trial in Humans
The use of systemic antibiotics as and adjunct to non-surgical peri-implant therapy may be an improvement in comparison to these therapies alone. The primary objective is the evaluation of significant changes in probing pocket depth between non-surgical with or without antibiotics.
This is a controlled-placebo clinical trial design. Patients with osseointegrated oral implants will be selected and recruited from a university clinic. Oral hygiene instruction and non-surgical debridement at implants will be provided with ultrasonic devices and immediately after, patients will be prescribed:
Group Control: A placebo with the same characteristics as the antibiotic Group Test: Systemic antibiotics (Metronidazole 250mg, 2 capsules three times a day, for 7 days Three and six months after non-surgical treatment, clinical parameters will be registered and radiographs compared using reproducible landmarks. Any adverse event will be also recorded.
Read the detailed description
Microbial colonization of implant surface is the main causative factor of periimplantitis. Non-surgical treatment have been shown to be ineffective in bacterial control. The capacity of certain bacteria to invade soft tissues in periodontal lesions and a possible invasion in peri-implant diseases, could also be a good reason. Mombelli and Lang in a case-series study observed a significant reduction on probing depths and microbial parameters after non-surgical treatment and systemic antimicrobial therapy (ornidazole) of implants affected by marked loss of bone.
The rationale for conducting this research is to demonstrate that there may be significant differences in clinical, radiographic and microbiological parameters if systemic metronidazole is prescribed in conjunction with non-surgical treatment of peri-implantitis lesions. If there are differences, and a further improvement is observed in evaluated parameters, treatment protocols for these prevalent lesions could have been modified.
The objective of this research is to check whether there are differences in clinical, radiographic and microbiological parameters when performing non-surgical treatment to treat peri-implantitis with adjunctive administration of systemic metronidazole or a placebo.
Design: This research is designed as a parallel group, placebo-controlled, randomized, double-blind clinical study.
Population: Patients who come to the Periodontology Department, Faculty of Dentistry, University of Santiago de Compostela with dental implants presenting pathology.
Treatment Groups: Study group: patients treated by non-surgical treatment in conjunction with systemic metronidazole.Control group: patients treated by non-surgical treatment in conjunction with a placebo.
Randomization:After checking the inclusion criteria, signing the informed consent and included in the study. All subjects will be randomly assigned a number and one of the treatment group. The randomization will be done by a computer program for a simple randomization assignment.
Treatment: Non-surgical treatments will be performed under local anaesthesia . In cases where the prosthesis is screwed and screw access is possible, it will be removed during treatment and re-placed once completed. The patient will rinse with a mouthwash of chlorhexidine digluconate 0.12% and then implants affected will be debrided by ultrasound and manual curettes with the objective of removing deposits of plaque and calculus that are attached to the surface of the implant or prosthesis. Once the debridement is finished, pockets will be irrigated with chlorhexidine for 2 minutes and the surface of the prostheses polished using rubber cups and polishing paste.Immediately after the end of treatment and depending on the result of randomization, the exact number of tablets of the antibiotic or placebo to be taken during the following days will be given to the patient. The patient will be instructed in oral hygiene with either manual or electric toothbrush and interdental hygiene at the time of the completion of treatment. Subsequently, at 4 weeks, motivation and hygiene instructions will be strengthened by modifying brushing technique when deemed necessary.
- Conditions
- Peri-Implantitis
- Being tested
- Placebo oral capsule, Metronidazole 250 MG
- Keywords
- Peri-implantitis, antibiotics, Metronidazole, non- surgical treatment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral capsuleDrug
Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the placebo to be taken during the following days will be given to the patient.
Metronidazole 250 MGDrug
Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the antibiotic to be taken during the following days will be given to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole 250mg | Active comparator | Systemic antibiotic: Metronidazole 250mg , 2 capsules three times a day, for 7 days. Receives: Drug: Metronidazole 250 MG |
| Placebo | Placebo comparator | Placebo: same shape, size and dosis as test Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing depth
Probing depth is the distance from the gingival margin to the bottom of the periodontal pocket (junctional epithelium). It is measured with a millimetric probe CP15 Hu-Friedy UNC at six points in each implant (mesial, distal and medial in buccal and lingual).
Measured: baseline, 2 and 6 months after treatment
Secondary outcomes (6)
Recession
the distance is measured from the free gingival margin (more coronal portion of the free gingiva) to the cement enamel junction. The following values are obtained:
- Zero: if the level of the cement enamel junction.
- Negative: the free gingival margin is apical to the cement enamel junction.
- Positive: when the free gingival margin is coronal to the cement enamel junction.
Measured: baseline, 2 and 6 months after treatment
Attachment level
Distance from the cement enamel junction to the bottom of the periodontal pocket (probing depth + recession).
Measured: baseline, 2 and 6 months after treatment
Bleeding Index
it will be recorded in six locations per tooth. It will be registered as presence or absence. If bleed- ing occured within 10-15 s, a positive score will be given.
Measured: baseline, 2 and 6 months after treatment
Peri-implant bone loss.
Distance from the implant shoulder to the first bone-implant contact in mesial and distal aspects of each implant.. The extent of peri-implant bone loss will be performed with Kodak® software and a correction of the vertical distortion of the x- rays will be done by the technique described by Tonetti et al. (1993).
Measured: baseline, 2 and 6 months after treatment
Microbiological variable
in terms of presence of periodontal pathogens and bacterial load. Deeper locations around each implant will be selected. The samples will be analyzed by real-time PCR. It will be recorded as the total percentage of each bacterium
Measured: baseline and 6 months after treatment
plaque index
it will be recorded in four locations per tooth. It will be registered as presence or absence. Plaque present along the gingival margin that could be easily removed with the tip of a probe was recorded. Percentage scores for the presence of plaque over all examined sites will be calculated for each patient.
Measured: baseline, 2 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 posted20 Jun 2018
- Study start3 Mar 2018
- Primary completion1 Mar 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PLACEBO-CONTROLLED CLINICAL TRIAL IN HUMAN
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Blanco Carrión
- Sponsor type
- University, hospital or other
- Collaborators
- Osteology Foundation
- Responsible party
- Sponsor-investigator, Juan Blanco Carrión, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564301
- Sponsor's protocol ID
- APB-MET-2017-01
- Status last verified
- Mar 2020
- First submitted
- 19 May 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.
PubMed 26285807Mombelli A, Lang NP. Antimicrobial treatment of peri-implant infections. Clin Oral Implants Res. 1992 Dec;3(4):162-8. doi: 10.1034/j.1600-0501.1992.030402.x.
PubMed 1298430Renvert S, Samuelsson E, Lindahl C, Persson GR. Mechanical non-surgical treatment of peri-implantitis: a double-blind randomized longitudinal clinical study. I: clinical results. J Clin Periodontol. 2009 Jul;36(7):604-9. doi: 10.1111/j.1600-051X.2009.01421.x.
PubMed 19538334Renvert S, Roos-Jansaker AM, Claffey N. Non-surgical treatment of peri-implant mucositis and peri-implantitis: a literature review. J Clin Periodontol. 2008 Sep;35(8 Suppl):305-15. doi: 10.1111/j.1600-051X.2008.01276.x.
PubMed 18724858Persson GR, Samuelsson E, Lindahl C, Renvert S. Mechanical non-surgical treatment of peri-implantitis: a single-blinded randomized longitudinal clinical study. II. Microbiological results. J Clin Periodontol. 2010 Jun;37(6):563-73. doi: 10.1111/j.1600-051X.2010.01561.x.
PubMed 20507380Linares A, Dopico J, Blanco C, Pico A, Sobrino T, Blanco J, Leira Y. The systemic impact of non-surgical treatment of peri-implantitis with or without adjunctive systemic metronidazole: Secondary analysis of a randomized clinical trial. Clin Oral Implants Res. 2024 Dec;35(12):1519-1530. doi: 10.1111/clr.14339. Epub 2024 Aug 2.
PubMed 39093380Blanco C, Pico A, Dopico J, Gandara P, Blanco J, Linares A. Adjunctive benefits of systemic metronidazole on non-surgical treatment of peri-implantitis. A randomized placebo-controlled clinical trial. J Clin Periodontol. 2022 Jan;49(1):15-27. doi: 10.1111/jcpe.13564. Epub 2021 Oct 28.
PubMed 34713471
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metronidazole as an Adjunct of Non- Surgical Treatment of Peri-implantitis : a 6-months Placebo- Controlled Clinical Trial in Humans
- ClinicalTrials.gov ID
- NCT03564301
- Acronym / sponsor ID
- APB-MET-2017-01
- Conditions
- Peri-Implantitis
- Keywords
- Peri-implantitis, antibiotics, Metronidazole, non- surgical treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Juan Blanco CarriónUniversity, hospital or other
- Collaborators
- Osteology Foundation
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 20 Jun 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.
The use of systemic antibiotics as and adjunct to non-surgical peri-implant therapy may be an improvement in comparison to these therapies alone. The primary objective is the evaluation of significant changes in probing pocket depth between non-surgical with or without antibiotics.
This is a controlled-placebo clinical trial design. Patients with osseointegrated oral implants will be selected and recruited from a university clinic. Oral hygiene instruction and non-surgical debridement at implants will be provided with ultrasonic devices and immediately after, patients will be prescribed:
Group Control: A placebo with the same characteristics as the antibiotic Group Test: Systemic antibiotics (Metronidazole 250mg, 2 capsules three times a day, for 7 days Three and six months after non-surgical treatment, clinical parameters will be registered and radiographs compared using reproducible landmarks. Any adverse event will be also recorded.
Detailed description
Microbial colonization of implant surface is the main causative factor of periimplantitis. Non-surgical treatment have been shown to be ineffective in bacterial control. The capacity of certain bacteria to invade soft tissues in periodontal lesions and a possible invasion in peri-implant diseases, could also be a good reason. Mombelli and Lang in a case-series study observed a significant reduction on probing depths and microbial parameters after non-surgical treatment and systemic antimicrobial therapy (ornidazole) of implants affected by marked loss of bone.
The rationale for conducting this research is to demonstrate that there may be significant differences in clinical, radiographic and microbiological parameters if systemic metronidazole is prescribed in conjunction with non-surgical treatment of peri-implantitis lesions. If there are differences, and a further improvement is observed in evaluated parameters, treatment protocols for these prevalent lesions could have been modified.
The objective of this research is to check whether there are differences in clinical, radiographic and microbiological parameters when performing non-surgical treatment to treat peri-implantitis with adjunctive administration of systemic metronidazole or a placebo.
Design: This research is designed as a parallel group, placebo-controlled, randomized, double-blind clinical study.
Population: Patients who come to the Periodontology Department, Faculty of Dentistry, University of Santiago de Compostela with dental implants presenting pathology.
Treatment Groups: Study group: patients treated by non-surgical treatment in conjunction with systemic metronidazole.Control group: patients treated by non-surgical treatment in conjunction with a placebo.
Randomization:After checking the inclusion criteria, signing the informed consent and included in the study. All subjects will be randomly assigned a number and one of the treatment group. The randomization will be done by a computer program for a simple randomization assignment.
Treatment: Non-surgical treatments will be performed under local anaesthesia . In cases where the prosthesis is screwed and screw access is possible, it will be removed during treatment and re-placed once completed. The patient will rinse with a mouthwash of chlorhexidine digluconate 0.12% and then implants affected will be debrided by ultrasound and manual curettes with the objective of removing deposits of plaque and calculus that are attached to the surface of the implant or prosthesis. Once the debridement is finished, pockets will be irrigated with chlorhexidine for 2 minutes and the surface of the prostheses polished using rubber cups and polishing paste.Immediately after the end of treatment and depending on the result of randomization, the exact number of tablets of the antibiotic or placebo to be taken during the following days will be given to the patient. The patient will be instructed in oral hygiene with either manual or electric toothbrush and interdental hygiene at the time of the completion of treatment. Subsequently, at 4 weeks, motivation and hygiene instructions will be strengthened by modifying brushing technique when deemed necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- PLACEBO-CONTROLLED CLINICAL TRIAL IN HUMAN
| Arm | Type | Receives |
|---|---|---|
| Metronidazole 250mg | Active comparator | Drug: Metronidazole 250 MGSystemic antibiotic: Metronidazole 250mg , 2 capsules three times a day, for 7 days. |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo: same shape, size and dosis as test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older than 18 years.
- Presence of at least 1 implant diagnosed with peri-implantitis (Presence of BOP and/or suppuration, with 2 mm of detectable bone loss after initial remodeling, and PD≥ 4 mm as defined by Daubert et al. 2015).
- Absence of implant mobility.
- History of taking systemic antibiotics in the preceding 3 months.
- No systemic pathology that contraindicated the completion of treatment.
Key exclusion criteria (4 listed)
- Pregnant.
- Metronidazole allergies
- Patients on treatment with bisphosphonates.
- Uncontrolled periodontal disease.
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 |
|---|---|---|
| Placebo oral capsuleImmediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the placebo to be taken during the following days will be given to the patient. | Drug | Placebo |
| Metronidazole 250 MGImmediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the antibiotic to be taken during the following days will be given to the patient. | Drug | Metronidazole 250mg |
Primary outcome
Change in probing depth
Time frame: baseline, 2 and 6 months after treatment
Probing depth is the distance from the gingival margin to the bottom of the periodontal pocket (junctional epithelium). It is measured with a millimetric probe CP15 Hu-Friedy UNC at six points in each implant (mesial, distal and medial in buccal and lingual).
6 secondary outcomes
Recession
Time frame: baseline, 2 and 6 months after treatment
Attachment level
Time frame: baseline, 2 and 6 months after treatment
Bleeding Index
Time frame: baseline, 2 and 6 months after treatment
Peri-implant bone loss.
Time frame: baseline, 2 and 6 months after treatment
Microbiological variable
Time frame: baseline and 6 months after treatment
plaque index
Time frame: baseline, 2 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 28 Apr 2021.
- Results publication: PubMed 26285807Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.
- Results publication: PubMed 1298430Mombelli A, Lang NP. Antimicrobial treatment of peri-implant infections. Clin Oral Implants Res. 1992 Dec;3(4):162-8. doi: 10.1034/j.1600-0501.1992.030402.x.
- Results publication: PubMed 19538334Renvert S, Samuelsson E, Lindahl C, Persson GR. Mechanical non-surgical treatment of peri-implantitis: a double-blind randomized longitudinal clinical study. I: clinical results. J Clin Periodontol. 2009 Jul;36(7):604-9. doi: 10.1111/j.1600-051X.2009.01421.x.
- Results publication: PubMed 18724858Renvert S, Roos-Jansaker AM, Claffey N. Non-surgical treatment of peri-implant mucositis and peri-implantitis: a literature review. J Clin Periodontol. 2008 Sep;35(8 Suppl):305-15. doi: 10.1111/j.1600-051X.2008.01276.x.
- Results publication: PubMed 20507380Persson GR, Samuelsson E, Lindahl C, Renvert S. Mechanical non-surgical treatment of peri-implantitis: a single-blinded randomized longitudinal clinical study. II. Microbiological results. J Clin Periodontol. 2010 Jun;37(6):563-73. doi: 10.1111/j.1600-051X.2010.01561.x.
- Derived from this study: PubMed 39093380Linares A, Dopico J, Blanco C, Pico A, Sobrino T, Blanco J, Leira Y. The systemic impact of non-surgical treatment of peri-implantitis with or without adjunctive systemic metronidazole: Secondary analysis of a randomized clinical trial. Clin Oral Implants Res. 2024 Dec;35(12):1519-1530. doi: 10.1111/clr.14339. Epub 2024 Aug 2.
- Derived from this study: PubMed 34713471Blanco C, Pico A, Dopico J, Gandara P, Blanco J, Linares A. Adjunctive benefits of systemic metronidazole on non-surgical treatment of peri-implantitis. A randomized placebo-controlled clinical trial. J Clin Periodontol. 2022 Jan;49(1):15-27. doi: 10.1111/jcpe.13564. Epub 2021 Oct 28.
- Mechanical non-surgical treatment of peri-implantitis: a single-blinded randomized longitudinal clinical study. II. Microbiological resultsLink provided by the sponsor.
- Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial.Link provided by the sponsor.
- Antimicrobial treatment of peri-implant infectionsLink provided by the sponsor.
- Mechanical non-surgical treatment of peri-implantitis: a double-blind randomized longitudinal clinical study.Link provided by the sponsor.
- Non-surgical treatment of peri-implant mucositis and peri-implantitis: a literature review.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole 250 MG in people with Peri-Implantitis, run by Juan Blanco Carrión at 1 site in Spain.
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 7 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 28 Apr 2021. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 in probing depth (time frame: baseline, 2 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?
On the ClinicalTrials.gov record for NCT03564301, which also lists 7 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 28 Apr 2021.