Peri-implantitisPhase 4NSTPNCT06715150
Non-Surgical Treatment of Peri-implantitis with Systemic Azithromycin or Placebo
A Phase 4 study testing Azithromcyin in people with Peri-implantitis, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
The primary objective of this study is to evaluate the change in probing depth in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) adjunctive to non-surgical treatment at 12 months. 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?
- Azithromcyin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2025to 10 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- older than 18 years;
- absence of systemic pathology contraindicating treatment;
- presence of at least 1 implant diagnosed with peri-implantitis: presence of bleeding on probing, probing depth ≥6 mm, and radiographic bone level ≥3 mm apical to the most coronal portion of the intraosseous part of the implant;
- absence of implant mobility;
- patients without periodontitis or with treated periodontitis;
- patients who understand the treatment and are willing to comply with it by providing written informed consent.
Who cannot join
- smokers ≥10 cigarettes/day;
- diabetic patients (HbA1c level ≥6,5%);
- pregnant or breastfeeding women;
- use of antibiotics, corticosteroids, and/or immunosuppressive treatment in the 3 months prior to the start of the study;
- allergy to azithromycin;
- patients with a history of bisphosphonate treatment;
Show all 9Show fewer
- chronic consumption of non-steroidal anti-inflammatory drugs;
- bone loss exceeding the apex of the implant;
- prosthesis that does not allow access to peri-implantitis treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Department of Surgery and Medical-Surgical Specialties, Teaching and Research Unit in Periodontology. Faculty of Medicine and Dentistry, University of Santiago de Compostela.
Santiago de Compostela, A Coruña, 15782
Antonio Liñares González, 626492454, antonio@antoniolinares.com
Juan Blanco Carrión
About this study
Official title: NON-SURGICAL TREATMENT of PERI-IMPLANTITIS with or WITHOUT SYSTEMIC AZITHROMYCIN: a RANDOMIZED CLINICAL TRIAL in HUMANS
The primary objective of this study is to evaluate the change in probing depth in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) adjunctive to non-surgical treatment at 12 months. The secondary objective is to assess clinical, radiographic, microbiological, and systemic changes at 3, 6, and 12 months.
This study is designed as a placebo-controlled, randomized, triple-blind clinical trial in subjects diagnosed with peri-implantitis.
The treatment will consist of debridement of the implant surface and curettage of the pocket epithelium. The control group will receive placebo (1 placebo tablet per day for 3 days), and the test group will receive systemic azithromycin 500 mg per day for 3 days (1 tablet of 500 mg azithromycin per day for 3 days).
Read the detailed description
Peri-implantitis is defined as the pathological alteration associated with plaque that occurs in the tissues surrounding dental implants, characterized by inflammation of the peri-implant mucosa and subsequent progressive loss of supporting bone. Bacterial colonization of the implant surface in a susceptible subject is considered the primary etiological factor of this pathology. Case series and clinical trials have demonstrated an additional benefit when using systemic antibiotics such as ornidazole or metronidazole after non-surgical treatment of peri-implantitis.
The rationale for conducting this clinical trial lies in the lack of randomized studies that have tested the non-surgical treatment of peri-implantitis with shorter antibiotic regimens and their potential impact on systemic health.
The primary objective of this randomized clinical trial is to evaluate the change in probing depth at 12 months in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) as an adjunct to the non-surgical treatment of peri-implantitis.
The secondary objective is to assess clinical, radiographic, and microbiological changes at 3, 6, and 12 months. Additionally, systemic biomarkers, complete blood count, glycosylated hemoglobin and creatinine will be evaluated at day 7, and 3, 6, and 12 months. Endothelial function (endothelium-dependent vasodilation measured in the brachial artery) and subclinical atherosclerosis (measurement of carotid artery intima-media thickness) will be evaluated at 12 months.
Design: This research is designed as a 1-year randomized controlled trial (RCT), with 2 parallel groups, triple-blind, and placebo-controlled.
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 azithromycin. Control group: patients treated by non-surgical treatment in conjunction with a placebo. Subjects will be randomly assigned to one of the two treatment groups.
Randomization: A balanced randomization by blocks will be performed to avoid imbalances between the two treatment groups. The randomization outcome will be stored in envelopes along with the antibiotic or placebo containers that will be delivered on the day of the non-surgical treatment.
Treatment: After the diagnosis of peri-implantitis, patients were instructed in oral hygiene and motivation was reinforced. After that, one session of nonsurgical treatment consisting of supra- and submucosal mechanical debridement using ultrasound with a metal periodontal tip was performed with concomitant irrigation of chlorhexidine of 0.12%. The tip removed granulation tissue and also touched the implant surface. After that, a steel curette Columbia 4R/4L was used to remove granulation tissue and minor mucosa curettage. If oral hygiene was not allowed by prosthetic design, a contour correction was made. Immediately after treatment, patients were prescribed to apply a chlorhexidine gel in the area 2 times a day for 2 weeks and depending on the result of randomization, the exact number of antibiotic or placebo tablets to be taken by the patient in the following days will be provided.
- Conditions
- Peri-implantitis
- Being tested
- Azithromcyin, Placebo
- Keywords
- Non-surgical treatment, Azithromycin, Systemic antibiotic
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromcyinDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin 500 mg | Active comparator | Systemic antibiotic: Azithromycin 500 mg every 24 hours for 3 days Receives: Drug: Azithromcyin |
| Placebo | Placebo comparator | Same shape, size and dosage as test Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing depth
The change in probing depth (quantitative dependent variable) at 12 months will be measured in millimeters as the distance from the mucosal margin to the bottom of the peri-implant pocket, using a millimetric CP15 UNC Hu-Friedy probe. The change in probing depth will also be measured at 3 and 6 months.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (18)
Recession
Distance from the implant shoulder to the margin of the peri-implant mucosa, measured in millimeters using a millimetric CP15 UNC Hu-Friedy probe. If the margin of the peri-implant mucosa is located apically to the implant shoulder, it will be recorded as a positive value (+); conversely, if the margin of the peri-implant mucosa is located coronally to the implant shoulder, it will be recorded as a negative value (-)
Measured: From enrollment to the end of treatment at 12 months
Clinical attachment level
Distance from the implant shoulder to the bottom of the peri-implant pocket (probing depth + recession) measured in millimeters using a millimetric CP15 UNC Hu-Friedy probe
Measured: From enrollment to the end of treatment at 12 months
Bleeding index
0: absent bleeding / 1: present bleeding
Measured: From enrollment to the end of treatment at 12 months
Plaque index
0: absent plaque / 1: present plaque
Measured: From enrollment to the end of treatment at 12 months
Width of the keratinized mucosa
From the peri-implant mucosal margin to the mucogingival line measured in millimeters using a millimetric CP15 UNC Hu-Friedy probe
Measured: From enrollment to the end of treatment at 12 months
Changes in radiographic bone level
Distance from the implant shoulder to the apical extent of the bone defect in mesial, distal, and total (calculated as the average of mesial and distal distances) of each implant on standardized periapical radiographs following the long cone paralleling technique with individualized positioning devices.
Measured: From enrollment to the end of treatment at 12 months
Change in bacterial load
The levels of the following pathogens will be determined: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Parvimonas micra, Fusobacterium nucleatum, Campylobacter rectus, Eikenella corrodens, Candida albicans and the total bacterial count.
Measured: From enrollment to the end of treatment at 12 months
Implant survival
Maintenance of each implant's function included in the study
Measured: From enrollment to the end of treatment at 12 months
Endothelial function
Measured by endothelium-dependent vasodilation in the brachial artery using a vascular ultrasound
Measured: From enrollment to the end of treatment at 12 months
Subclinical atherosclerosis
Measured by the intima-media thickness of the carotid artery using a vascular ultrasound
Measured: From enrollment to the end of treatment at 12 months
Concentration of inflammatory cytokines biomarkers
The predetermined biomarkers to be analyzed include a multiplex inflammatory panel (IL-1β, IL-12p70, IFN-γ, IL-6, IL-10, IL-8, TNF-α), measured in pg/mL
Measured: From enrollment to the end of treatment at 12 months
Concentration of endothelial activation/injury markers
Endothelial activation/injury markers (E-selectin, P-selectin, thrombomodulin, ICAM-1, ICAM-3, VCAM-1), measured in ng/mL
Measured: From enrollment to the end of treatment at 12 months
Concentration of serum C-reactive protein
C-reactive protein (CRP), measured in mg/L using Meso Scale assays (pro-inflammatory 7-PLEX, Vascular Injury Panel I, and V-PLEX Panel II)
Measured: From enrollment to the end of treatment at 12 months
Concentration of serum amyloid A
Serum amyloid A (SAA), measured in µg/mL using Meso Scale assays (pro-inflammatory 7-PLEX, Vascular Injury Panel I, and V-PLEX Panel II)
Measured: From enrollment to the end of treatment at 12 months
Concentration of circulating blood cells
Circulating blood cells will be measured in 10³/µL
Measured: From enrollment to the end of treatment at 12 months
Concentration of high-sensitivity CRP
High-sensitivity CRP (hs-CRP) will be assessed using ELISA, in mg/L
Measured: From enrollment to the end of treatment at 12 months
Rate of lipid fractions
Lipid fractions (triglycerides, total cholesterol, HDL, LDL) will be assessed in mg/dL using standard biochemical methods
Measured: From enrollment to the end of treatment at 12 months
Treatment success
Treatment success will be established as achieving a probing depth ≤5 mm, without bleeding in more than one point, and without suppuration, in each implant included in the study.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start10 Jan 2025 (estimated)
- Primary completion10 Jan 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Blanco Carrión, University of Santiago de Compostela
- Investigators
- Juan Blanco Carrión, Principal investigator, Universidade de Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715150
- Sponsor's protocol ID
- USC77/2024
- Other IDs
- Self founding
- Acronym
- NSTP
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orlandi M, Pranno N, Patel V, Papi P, Di Murro B, Pompa G, Polimeni A, Letizia C, Suvan J, D'Aiuto F. Peri-implant diseases and systemic inflammation: A preliminary analysis from a cross-sectional survey of patients with hypertension. J Periodontol. 2024 Jun;95(6):525-534. doi: 10.1002/JPER.21-0338. Epub 2024 May 14.
PubMed 38742572Blanco C, Linares A, Dopico J, Pico A, Sobrino T, Leira Y, Blanco J. Peri-implantitis, systemic inflammation, and dyslipidemia: a cross-sectional biochemical study. J Periodontal Implant Sci. 2021 Oct;51(5):342-351. doi: 10.5051/jpis.2100920046.
PubMed 34713995Linares A, Pico A, Blanco C, Blanco J. Adjunctive Systemic Metronidazole to Nonsurgical Therapy of Peri-implantitis with Intrabony Defects: A Retrospective Case Series Study. Int J Oral Maxillofac Implants. 2019 Sep/Oct;34(5):1237-1245. doi: 10.11607/jomi.7343.
PubMed 31528867Renvert S, Lessem J, Dahlen G, Renvert H, Lindahl C. Mechanical and repeated antimicrobial therapy using a local drug delivery system in the treatment of peri-implantitis: a randomized clinical trial. J Periodontol. 2008 May;79(5):836-44. doi: 10.1902/jop.2008.070347.
PubMed 18454662Linares A, Sanz-Sanchez I, Dopico J, Molina A, Blanco J, Montero E. Efficacy of adjunctive measures in the non-surgical treatment of peri-implantitis: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:224-243. doi: 10.1111/jcpe.13821. Epub 2023 May 4.
PubMed 37143407Estefania-Fresco R, Garcia-de-la-Fuente AM, Egana-Fernandez-Valderrama A, Bravo M, Aguirre-Zorzano LA. One-year results of a nonsurgical treatment protocol for peri-implantitis. A retrospective case series. Clin Oral Implants Res. 2019 Jul;30(7):702-712. doi: 10.1111/clr.13456. Epub 2019 Jun 1.
PubMed 31090974Blanco 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NON-SURGICAL TREATMENT of PERI-IMPLANTITIS with or WITHOUT SYSTEMIC AZITHROMYCIN: a RANDOMIZED CLINICAL TRIAL in HUMANS
- ClinicalTrials.gov ID
- NCT06715150
- Acronym / sponsor ID
- NSTP / USC77/2024
- Conditions
- Peri-implantitis
- Keywords
- Non-surgical treatment, Azithromycin, Systemic antibiotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the change in probing depth in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) adjunctive to non-surgical treatment at 12 months. The secondary objective is to assess clinical, radiographic, microbiological, and systemic changes at 3, 6, and 12 months.
This study is designed as a placebo-controlled, randomized, triple-blind clinical trial in subjects diagnosed with peri-implantitis.
The treatment will consist of debridement of the implant surface and curettage of the pocket epithelium. The control group will receive placebo (1 placebo tablet per day for 3 days), and the test group will receive systemic azithromycin 500 mg per day for 3 days (1 tablet of 500 mg azithromycin per day for 3 days).
Detailed description
Peri-implantitis is defined as the pathological alteration associated with plaque that occurs in the tissues surrounding dental implants, characterized by inflammation of the peri-implant mucosa and subsequent progressive loss of supporting bone. Bacterial colonization of the implant surface in a susceptible subject is considered the primary etiological factor of this pathology. Case series and clinical trials have demonstrated an additional benefit when using systemic antibiotics such as ornidazole or metronidazole after non-surgical treatment of peri-implantitis.
The rationale for conducting this clinical trial lies in the lack of randomized studies that have tested the non-surgical treatment of peri-implantitis with shorter antibiotic regimens and their potential impact on systemic health.
The primary objective of this randomized clinical trial is to evaluate the change in probing depth at 12 months in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) as an adjunct to the non-surgical treatment of peri-implantitis.
The secondary objective is to assess clinical, radiographic, and microbiological changes at 3, 6, and 12 months. Additionally, systemic biomarkers, complete blood count, glycosylated hemoglobin and creatinine will be evaluated at day 7, and 3, 6, and 12 months. Endothelial function (endothelium-dependent vasodilation measured in the brachial artery) and subclinical atherosclerosis (measurement of carotid artery intima-media thickness) will be evaluated at 12 months.
Design: This research is designed as a 1-year randomized controlled trial (RCT), with 2 parallel groups, triple-blind, and placebo-controlled.
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 azithromycin. Control group: patients treated by non-surgical treatment in conjunction with a placebo. Subjects will be randomly assigned to one of the two treatment groups.
Randomization: A balanced randomization by blocks will be performed to avoid imbalances between the two treatment groups. The randomization outcome will be stored in envelopes along with the antibiotic or placebo containers that will be delivered on the day of the non-surgical treatment.
Treatment: After the diagnosis of peri-implantitis, patients were instructed in oral hygiene and motivation was reinforced. After that, one session of nonsurgical treatment consisting of supra- and submucosal mechanical debridement using ultrasound with a metal periodontal tip was performed with concomitant irrigation of chlorhexidine of 0.12%. The tip removed granulation tissue and also touched the implant surface. After that, a steel curette Columbia 4R/4L was used to remove granulation tissue and minor mucosa curettage. If oral hygiene was not allowed by prosthetic design, a contour correction was made. Immediately after treatment, patients were prescribed to apply a chlorhexidine gel in the area 2 times a day for 2 weeks and depending on the result of randomization, the exact number of antibiotic or placebo tablets to be taken by the patient in the following days will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin 500 mg | Active comparator | Drug: AzithromcyinSystemic antibiotic: Azithromycin 500 mg every 24 hours for 3 days |
| Placebo | Placebo comparator | Other: PlaceboSame shape, size and dosage as test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- older than 18 years;
- absence of systemic pathology contraindicating treatment;
- presence of at least 1 implant diagnosed with peri-implantitis: presence of bleeding on probing, probing depth ≥6 mm, and radiographic bone level ≥3 mm apical to the most coronal portion of the intraosseous part of the implant;
- absence of implant mobility;
- patients without periodontitis or with treated periodontitis;
Key exclusion criteria (9 listed)
- smokers ≥10 cigarettes/day;
- diabetic patients (HbA1c level ≥6,5%);
- pregnant or breastfeeding women;
- use of antibiotics, corticosteroids, and/or immunosuppressive treatment in the 3 months prior to the start of the study;
- allergy to azithromycin;
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 |
|---|---|---|
| AzithromcyinImmediately 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 | Azithromycin 500 mg |
| PlaceboImmediately 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. | Other | Placebo |
Primary outcome
Change in probing depth
Time frame: From enrollment to the end of treatment at 12 months
The change in probing depth (quantitative dependent variable) at 12 months will be measured in millimeters as the distance from the mucosal margin to the bottom of the peri-implant pocket, using a millimetric CP15 UNC Hu-Friedy probe. The change in probing depth will also be measured at 3 and 6 months.
18 secondary outcomes
Recession
Time frame: From enrollment to the end of treatment at 12 months
Clinical attachment level
Time frame: From enrollment to the end of treatment at 12 months
Bleeding index
Time frame: From enrollment to the end of treatment at 12 months
Plaque index
Time frame: From enrollment to the end of treatment at 12 months
Width of the keratinized mucosa
Time frame: From enrollment to the end of treatment at 12 months
Changes in radiographic bone level
Time frame: From enrollment to the end of treatment at 12 months
Change in bacterial load
Time frame: From enrollment to the end of treatment at 12 months
Implant survival
Time frame: From enrollment to the end of treatment at 12 months
Endothelial function
Time frame: From enrollment to the end of treatment at 12 months
Subclinical atherosclerosis
Time frame: From enrollment to the end of treatment at 12 months
Concentration of inflammatory cytokines biomarkers
Time frame: From enrollment to the end of treatment at 12 months
Concentration of endothelial activation/injury markers
Time frame: From enrollment to the end of treatment at 12 months
Concentration of serum C-reactive protein
Time frame: From enrollment to the end of treatment at 12 months
Concentration of serum amyloid A
Time frame: From enrollment to the end of treatment at 12 months
Concentration of circulating blood cells
Time frame: From enrollment to the end of treatment at 12 months
Concentration of high-sensitivity CRP
Time frame: From enrollment to the end of treatment at 12 months
Rate of lipid fractions
Time frame: From enrollment to the end of treatment at 12 months
Treatment success
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 38742572Orlandi M, Pranno N, Patel V, Papi P, Di Murro B, Pompa G, Polimeni A, Letizia C, Suvan J, D'Aiuto F. Peri-implant diseases and systemic inflammation: A preliminary analysis from a cross-sectional survey of patients with hypertension. J Periodontol. 2024 Jun;95(6):525-534. doi: 10.1002/JPER.21-0338. Epub 2024 May 14.
- Background: PubMed 34713995Blanco C, Linares A, Dopico J, Pico A, Sobrino T, Leira Y, Blanco J. Peri-implantitis, systemic inflammation, and dyslipidemia: a cross-sectional biochemical study. J Periodontal Implant Sci. 2021 Oct;51(5):342-351. doi: 10.5051/jpis.2100920046.
- Background: PubMed 31528867Linares A, Pico A, Blanco C, Blanco J. Adjunctive Systemic Metronidazole to Nonsurgical Therapy of Peri-implantitis with Intrabony Defects: A Retrospective Case Series Study. Int J Oral Maxillofac Implants. 2019 Sep/Oct;34(5):1237-1245. doi: 10.11607/jomi.7343.
- Background: PubMed 18454662Renvert S, Lessem J, Dahlen G, Renvert H, Lindahl C. Mechanical and repeated antimicrobial therapy using a local drug delivery system in the treatment of peri-implantitis: a randomized clinical trial. J Periodontol. 2008 May;79(5):836-44. doi: 10.1902/jop.2008.070347.
- Background: PubMed 37143407Linares A, Sanz-Sanchez I, Dopico J, Molina A, Blanco J, Montero E. Efficacy of adjunctive measures in the non-surgical treatment of peri-implantitis: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:224-243. doi: 10.1111/jcpe.13821. Epub 2023 May 4.
- Background: PubMed 31090974Estefania-Fresco R, Garcia-de-la-Fuente AM, Egana-Fernandez-Valderrama A, Bravo M, Aguirre-Zorzano LA. One-year results of a nonsurgical treatment protocol for peri-implantitis. A retrospective case series. Clin Oral Implants Res. 2019 Jul;30(7):702-712. doi: 10.1111/clr.13456. Epub 2019 Jun 1.
- Background: 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Blanco Carrión principal investigator
Universidade de Santiago de Compostela
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 Azithromcyin in people with Peri-implantitis, run by University of Santiago de Compostela 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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Liñares González (+34 626492454, antonio@antoniolinares.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in probing depth (time frame: From enrollment to the end of treatment at 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 NCT06715150, 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 10 Dec 2024.