PeriodontitisNCT05506371
Effects of Azithromycin as an Adjunct to Scaling and Root Planning in the Treatment of Periodontitis
A study testing Az+SRP and SRP in people with Periodontitis, run by Ukrainian Medical Stomatological Academy at 1 site in Ukraine.
Trial summary
The growing interest in the possibilities of modulating macrophages in inflammatory diseases with therapeutic purpose has prompted the development of new approaches for the treatment of periodontitis. Read more about this study
- Who is it for?
- Ages 19 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Az+SRP and SRP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUkraine
- Study dates
- 16 Sep 2017to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of more than 20 teeth (for each tooth, the probing pocket depth ≤3 mm
- Absence of clinical gingival inflammation at intact or reduced periodontium
- The presence of at least 15 natural teeth, at least 10 sites with the periodontal pocket depth (PPD) ≥4 mm, and/or clinical attachment loss of ≥4 mm at the same site, and satisfactory general health
Who cannot join
- Taking antibiotics or anti-inflammatory medications within the previous 3 months
- Periodontal therapy within the previous 6 months
- Purulent exudation from periodontal pockets
- Pregnancy or breastfeeding
- Severe, uncontrolled (decompensated) diseases of the internal organs, or neuropsychiatric disorders
- Other conditions that determined the patient's inability to understand the nature and possible consequences of the study
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
Department of Postgraduate Education for Dentists of Poltava State Medical University,
Poltava, 36011
About this study
Official title: Azithromycin as an Adjunct to Scaling and Root Planning Causes an Increase of CD68+, CD163+ Macrophages Density in the Gingival Tissues of Periodontitis Patients: a Randomized Controlled Short-term Clinical Trial
The growing interest in the possibilities of modulating macrophages in inflammatory diseases with therapeutic purpose has prompted the development of new approaches for the treatment of periodontitis.
This randomized add-on open clinical study evaluated the short-term effects of azithromycin (Az) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis.
Read more
The investigators measured periodontal parameters, and collected gingival biopsies from patients with periodontitis (P group, n=50) before and 1 month after scaling and root planning (SRP group, n=25), after scaling and root planning with oral azithromycin administration (Az group, n=25), and from periodontally healthy individuals (H group, n=25). The last served as a reference group. Macrophage subpopulations were identified through immunohistochemistry as single positive CD68+ and CD163+ cells. The levels of M1-, and M2-related cytokines (IL1-β, IL-6, IL-10, TGF-β) assay in the tissue culture medium was provided by ELISA. The data were statistically analyzed by appropriate methods.
The null hypothesis tested was that L-arginine and L-ornithine have no influences on CD68+ and CD163+ Mφs densities.
Read the detailed description
Clinical periodontal examinations Periodontal parameters were evaluated at the pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP. For all participants, sex and age were recorded, and periodontal parameters such periodontal pocket depth (PPD), clinical attachment loss (CAL), and bleeding on probing (BoP) were examined. All measurements were conducted by one calibrated examiner using a manual periodontal probe (0106.DT06.CP10, Den Tag, Italy). PPD and CAL were measured at six periodontal sites around each tooth (including the third molars) to the nearest 1 mm, and maximal values were taken into account. For H group participants the signs of gingival inflammation, probing depth exceeding 3 mm and BoP were exclude to insure periodontal health.
Periodontal therapy was comprised of home oral hygiene instructions and SRP. It was performed using ultrasonic, Gracey curettes and air-abrasive polishing. Measure for compliance control included counting pills and home hygiene checking.
Collection of gingival tissue samples For precise immunohistochemical study gingival biopsy samples, about 3x3 mm was excised following local anesthesia from all participants without any harm, during appropriate dental procedures. Biopsy from periodontitis-affected gingiva performed at pre-treatment (T0, P Group) and 4 weeks ±5 days after the completion of periodontal treatment, in the same or nearest points, from a single most severe clinical appropriate site around common dental and periodontal procedures such was tooth extraction due to caries complications, and gingivectomies. Biopsy from periodontally healthy patients were obtained during tooth extraction due to caries complications, wisdom teeth and orthodontic indications. After collection, the half of biopsies were fixed in a 4% formalin solution for 24 hours of fixation, dehydrated, and embedded in paraffin, and another half were prepared for cytokines assay.
Immunohistochemistry and antibodies Paraffin sections, 2-3 μm in thickness were deparaffinized and dehydrated. Heat-induced epitope retrieval in citrate buffer, pH 6, was performed by heating the slides in the microwave oven for 23 min, then allowed to cool, rinsed with phosphate-buffered saline (PBS), incubated with blocked reagent, rinsed, and incubated with mouse monoclonal CD68 macrophage antibodies (1:30, clone PG-M1, Diagnostic BioSystems, The Hague, The Netherlands) or anti-CD163 (1:100, clone 10D6, Diagnostic BioSystems, The Hague, The Netherlands). Then sections were stained with the 2-steps plus Mouse/Rabbit PolyVueTM HRP/DAB Detection System (Diagnostic BioSystems, The Hague, The Netherlands), and counterstained with Mayer's haemalaun. PBS was used as negative controls, the lymph node tissue - as a positive control.
Evaluation of immunohistochemical staining СD68+ and CD163+ macrophages were estimated by counting the number of the cells by light microscope in 400 times in intensive cell infiltrative areas, selected 5 regions from each slice, and all 5 counts were taken for further statistics. Immunopositive Mφs in the areas of cell infiltration were count, because of directly relation to the inflammation. The number of cells per 10 000 μm2 was calculated as immunopositive cell density. Photos and calculation were obtained using the light microscope Axio Lab.A1 (Carl Zeiss, Göttingen, Germany) (×400).
Tissue culturing Part of gingival tissue samples were cultured in a humidified incubator at 37 °C and in the presence of 5 % CO2. Biopsies were cultured in Dulbecco's modified Eagle medium (DMEM) supplemented with 10 % (vol/vol) fetal bovine serum (Gibco, Thermo Fisher Scientific, Gibco™, US), 1 % (vol/vol) penicillin-streptomycin (Gibco™, US), and 0.2 % (vol/vol) fungizone amphotericin B (Gibco™, US) during 48 h [16]. For culturing, each biopsy sample was placed in a separate well of Costar® 24-well Plates (Corning Incorporated - Life Sciences, Kennebunk, USA), containing 0,4 ml of supplemented DMEM. After incubation, the tissues were removed and culture media were centrifuged at 800 g and 4 °C.
Cytokine assay Cytokine assay in the tissue culture medium was provided by ELISA. IL1-β, IL-6, IL-10, and TGF-β concentrations were measured by commercially available kits (Vector Best, Novosibirsk, Russia, and MyBioSource, San Diego, USA). Cytokine concentrations were expressed as recommended by the manufacturer.
Statistical analysis Statistical analysis was performed using the Prism 5 software (GraphPad Software, San Diego, USA) by means of nonparametric (descriptive statistics, Wilcoxon matched-pairs signed-rank test - for comparison of dependent results, Mann-Whitney test - for independent groups; nonparametric ANOVA for multiple comparisons with post-hoc tests, and Spearmen correlation). CD68+/CD163+ ratio was assessed by inter-group comparisons and Spearman correlation checking. P values of <0.05 were considered statistically significant in all analyses. For descriptive statistics of cell numbers, the percentile ranges were also used because of non-normal variables distributions.
- Conditions
- Periodontitis
- Being tested
- Az+SRP, SRP, No interventions
- Keywords
- Azithromycin, M1 macrophages, M2 macrophages, Macrophages-targeted therapy, Periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Az+SRPDrug
Also called Azithromicyn group
Azithromycin as an adjunct to scaling and root planning in the treatment of periodontitis
SRPDrug
Also called Periodontal conventional treatment group
Scaling and root planning (SRP) treatment of periodontitis
No interventionsDrug
Also called Reference/periodontal health group
Diagnostocs to confirm the healthy state of the gingiva
| Study group | Role | What they receive |
|---|---|---|
| Az group | Experimental | Periodontitis patients, who underwent scaling and root planning (SRP) as one-stage full-mouth disinfection procedure and additionally received oral azithromycin ("Health" Pharmaceutical Company, Kharkiv, Ukraine) in a dose of 500 mg q.d. for 7 days, then 500 mg q.w. for the next 3 weeks Receives: Drug: Az+SRP |
| SRP group | Active comparator | Periodontitis patients who underwent scaling and root planning (SRP) as one-stage full-mouth disinfection procedure. Receives: Drug: SRP |
| H group | Other | Reference group. 25 healthy volunteers who underwent only diagnostics to confirm the clinical healthy state of the gingiva Receives: Drug: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical attachment loss (CAL)
Mean CAL, measured at six periodontal sites around each tooth (including the third molars) to the nearest 1 mm
Measured: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in periodontal pocket depth (PPD)
Mean periodontal pocket depth, measured at six periodontal sites around each tooth (including the third molars) to the nearest 1 mm
Measured: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Secondary outcomes (7)
Change in bleeding on probing (BOP)
The percentage of sites per patient with bleeding measured at six sites around each tooth (including the third molars)
Measured: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in density of CD68+ macrophages
The number of single-immunopositive macrophages per 10 000 μm2 was calculated as cell density in biopsy from periodontitis-affected gingiva
Measured: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in density of CD163+ macrophages
The number of single-immunopositive macrophages per 10 000 μm2 was calculated as cell density in biopsy from periodontitis-affected gingiva
Measured: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in mean level of IL1-β in periodontitis-affected gingiva
The mean level of IL1-β in the tissue culture medium, obtained from the same biopsy
Measured: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in mean level of IL-6 in periodontitis-affected gingiva
The mean level of IL-6 in the tissue culture medium, obtained from the same biopsy
Measured: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in mean level of IL-10 in periodontitis-affected gingiva
The mean level of IL-10 in the tissue culture medium, obtained from the biopsy
Measured: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in mean level of TGF-β in periodontitis-affected gingiva
The mean level of TGF-β in the tissue culture medium, obtained from the biopsy
Measured: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start16 Sep 2017
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled short-term clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ukrainian Medical Stomatological Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Kaydashev, Ukrainian Medical Stomatological Academy
- Investigators
- Igor P. Kaidashev, MD, Principal investigator, Ukrainian Medical Stomatological Academy Poltava, Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506371
- Sponsor's protocol ID
- 0122U00049
- Status last verified
- Oct 2023
- First submitted
- 14 Aug 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to provide all the necessary data in a future article.
Publications
Morales A, Contador R, Bravo J, Carvajal P, Silva N, Strauss FJ, Gamonal J. Clinical effects of probiotic or azithromycin as an adjunct to scaling and root planning in the treatment of stage III periodontitis: a pilot randomized controlled clinical trial. BMC Oral Health. 2021 Jan 7;21(1):12. doi: 10.1186/s12903-020-01276-3.
PubMed 33413320Haffajee AD, Socransky SS, Ebersole JL. Survival analysis of periodontal sites before and after periodontal therapy. J Clin Periodontol. 1985 Aug;12(7):553-67. doi: 10.1111/j.1600-051x.1985.tb01389.x.
PubMed 3860518Mills CD, Lenz LL, Ley K. Macrophages at the fork in the road to health or disease. Front Immunol. 2015 Feb 16;6:59. doi: 10.3389/fimmu.2015.00059. eCollection 2015. No abstract available.
PubMed 25762997Zhou LN, Bi CS, Gao LN, An Y, Chen F, Chen FM. Macrophage polarization in human gingival tissue in response to periodontal disease. Oral Dis. 2019 Jan;25(1):265-273. doi: 10.1111/odi.12983. Epub 2018 Oct 12.
PubMed 30285304Shapouri-Moghaddam A, Mohammadian S, Vazini H, Taghadosi M, Esmaeili SA, Mardani F, Seifi B, Mohammadi A, Afshari JT, Sahebkar A. Macrophage plasticity, polarization, and function in health and disease. J Cell Physiol. 2018 Sep;233(9):6425-6440. doi: 10.1002/jcp.26429. Epub 2018 Mar 1.
PubMed 29319160Allam JP, Duan Y, Heinemann F, Winter J, Gotz W, Deschner J, Wenghoefer M, Bieber T, Jepsen S, Novak N. IL-23-producing CD68(+) macrophage-like cells predominate within an IL-17-polarized infiltrate in chronic periodontitis lesions. J Clin Periodontol. 2011 Oct;38(10):879-86. doi: 10.1111/j.1600-051X.2011.01752.x. Epub 2011 Aug 31.
PubMed 21883359Fabriek BO, Dijkstra CD, van den Berg TK. The macrophage scavenger receptor CD163. Immunobiology. 2005;210(2-4):153-60. doi: 10.1016/j.imbio.2005.05.010.
PubMed 16164022Parnham MJ, Erakovic Haber V, Giamarellos-Bourboulis EJ, Perletti G, Verleden GM, Vos R. Azithromycin: mechanisms of action and their relevance for clinical applications. Pharmacol Ther. 2014 Aug;143(2):225-45. doi: 10.1016/j.pharmthera.2014.03.003. Epub 2014 Mar 11.
PubMed 24631273Fujise O, Miura M, Hamachi T, Aida Y, Nishimura F. Regenerative effect of azithromycin on periodontitis with different levels of gingival inflammation: three case reports. Aust Dent J. 2014 Jun;59(2):245-51. doi: 10.1111/adj.12177.
PubMed 24861402Nepokupnaia-Slobodianuk TS, Skripnikov PN. [The clinical effectiveness of long-term azithromycin in patients with chronic generalized periodontitis]. Georgian Med News. 2014 Nov;(236):27-31. Russian.
PubMed 25541821Hai R, Chu A, Li H, Umamoto S, Rider P, Liu F. Infection of human cytomegalovirus in cultured human gingival tissue. Virol J. 2006 Oct 5;3:84. doi: 10.1186/1743-422X-3-84.
PubMed 17022821Loos BG, Needleman I. Endpoints of active periodontal therapy. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):61-71. doi: 10.1111/jcpe.13253.
PubMed 31912527Garaicoa-Pazmino C, Fretwurst T, Squarize CH, Berglundh T, Giannobile WV, Larsson L, Castilho RM. Characterization of macrophage polarization in periodontal disease. J Clin Periodontol. 2019 Aug;46(8):830-839. doi: 10.1111/jcpe.13156. Epub 2019 Jun 25.
PubMed 31152604Zhu L, Zhao Q, Yang T, Ding W, Zhao Y. Cellular metabolism and macrophage functional polarization. Int Rev Immunol. 2015 Jan;34(1):82-100. doi: 10.3109/08830185.2014.969421. Epub 2014 Oct 23.
PubMed 25340307Zhu LF, Li L, Wang XQ, Pan L, Mei YM, Fu YW, Xu Y. M1 macrophages regulate TLR4/AP1 via paracrine to promote alveolar bone destruction in periodontitis. Oral Dis. 2019 Nov;25(8):1972-1982. doi: 10.1111/odi.13167. Epub 2019 Oct 18.
PubMed 31361069
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin as an Adjunct to Scaling and Root Planning Causes an Increase of CD68+, CD163+ Macrophages Density in the Gingival Tissues of Periodontitis Patients: a Randomized Controlled Short-term Clinical Trial
- ClinicalTrials.gov ID
- NCT05506371
- Acronym / sponsor ID
- 0122U00049
- Conditions
- Periodontitis
- Keywords
- Azithromycin, M1 macrophages, M2 macrophages, Macrophages-targeted therapy, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ukrainian Medical Stomatological AcademyUniversity, hospital or other
- Study start
- 16 Sep 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 18 Aug 2022 (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 growing interest in the possibilities of modulating macrophages in inflammatory diseases with therapeutic purpose has prompted the development of new approaches for the treatment of periodontitis.
This randomized add-on open clinical study evaluated the short-term effects of azithromycin (Az) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis.
The investigators measured periodontal parameters, and collected gingival biopsies from patients with periodontitis (P group, n=50) before and 1 month after scaling and root planning (SRP group, n=25), after scaling and root planning with oral azithromycin administration (Az group, n=25), and from periodontally healthy individuals (H group, n=25). The last served as a reference group. Macrophage subpopulations were identified through immunohistochemistry as single positive CD68+ and CD163+ cells. The levels of M1-, and M2-related cytokines (IL1-β, IL-6, IL-10, TGF-β) assay in the tissue culture medium was provided by ELISA. The data were statistically analyzed by appropriate methods.
The null hypothesis tested was that L-arginine and L-ornithine have no influences on CD68+ and CD163+ Mφs densities.
Detailed description
Clinical periodontal examinations Periodontal parameters were evaluated at the pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP. For all participants, sex and age were recorded, and periodontal parameters such periodontal pocket depth (PPD), clinical attachment loss (CAL), and bleeding on probing (BoP) were examined. All measurements were conducted by one calibrated examiner using a manual periodontal probe (0106.DT06.CP10, Den Tag, Italy). PPD and CAL were measured at six periodontal sites around each tooth (including the third molars) to the nearest 1 mm, and maximal values were taken into account. For H group participants the signs of gingival inflammation, probing depth exceeding 3 mm and BoP were exclude to insure periodontal health.
Periodontal therapy was comprised of home oral hygiene instructions and SRP. It was performed using ultrasonic, Gracey curettes and air-abrasive polishing. Measure for compliance control included counting pills and home hygiene checking.
Collection of gingival tissue samples For precise immunohistochemical study gingival biopsy samples, about 3x3 mm was excised following local anesthesia from all participants without any harm, during appropriate dental procedures. Biopsy from periodontitis-affected gingiva performed at pre-treatment (T0, P Group) and 4 weeks ±5 days after the completion of periodontal treatment, in the same or nearest points, from a single most severe clinical appropriate site around common dental and periodontal procedures such was tooth extraction due to caries complications, and gingivectomies. Biopsy from periodontally healthy patients were obtained during tooth extraction due to caries complications, wisdom teeth and orthodontic indications. After collection, the half of biopsies were fixed in a 4% formalin solution for 24 hours of fixation, dehydrated, and embedded in paraffin, and another half were prepared for cytokines assay.
Immunohistochemistry and antibodies Paraffin sections, 2-3 μm in thickness were deparaffinized and dehydrated. Heat-induced epitope retrieval in citrate buffer, pH 6, was performed by heating the slides in the microwave oven for 23 min, then allowed to cool, rinsed with phosphate-buffered saline (PBS), incubated with blocked reagent, rinsed, and incubated with mouse monoclonal CD68 macrophage antibodies (1:30, clone PG-M1, Diagnostic BioSystems, The Hague, The Netherlands) or anti-CD163 (1:100, clone 10D6, Diagnostic BioSystems, The Hague, The Netherlands). Then sections were stained with the 2-steps plus Mouse/Rabbit PolyVueTM HRP/DAB Detection System (Diagnostic BioSystems, The Hague, The Netherlands), and counterstained with Mayer's haemalaun. PBS was used as negative controls, the lymph node tissue - as a positive control.
Evaluation of immunohistochemical staining СD68+ and CD163+ macrophages were estimated by counting the number of the cells by light microscope in 400 times in intensive cell infiltrative areas, selected 5 regions from each slice, and all 5 counts were taken for further statistics. Immunopositive Mφs in the areas of cell infiltration were count, because of directly relation to the inflammation. The number of cells per 10 000 μm2 was calculated as immunopositive cell density. Photos and calculation were obtained using the light microscope Axio Lab.A1 (Carl Zeiss, Göttingen, Germany) (×400).
Tissue culturing Part of gingival tissue samples were cultured in a humidified incubator at 37 °C and in the presence of 5 % CO2. Biopsies were cultured in Dulbecco's modified Eagle medium (DMEM) supplemented with 10 % (vol/vol) fetal bovine serum (Gibco, Thermo Fisher Scientific, Gibco™, US), 1 % (vol/vol) penicillin-streptomycin (Gibco™, US), and 0.2 % (vol/vol) fungizone amphotericin B (Gibco™, US) during 48 h [16]. For culturing, each biopsy sample was placed in a separate well of Costar® 24-well Plates (Corning Incorporated - Life Sciences, Kennebunk, USA), containing 0,4 ml of supplemented DMEM. After incubation, the tissues were removed and culture media were centrifuged at 800 g and 4 °C.
Cytokine assay Cytokine assay in the tissue culture medium was provided by ELISA. IL1-β, IL-6, IL-10, and TGF-β concentrations were measured by commercially available kits (Vector Best, Novosibirsk, Russia, and MyBioSource, San Diego, USA). Cytokine concentrations were expressed as recommended by the manufacturer.
Statistical analysis Statistical analysis was performed using the Prism 5 software (GraphPad Software, San Diego, USA) by means of nonparametric (descriptive statistics, Wilcoxon matched-pairs signed-rank test - for comparison of dependent results, Mann-Whitney test - for independent groups; nonparametric ANOVA for multiple comparisons with post-hoc tests, and Spearmen correlation). CD68+/CD163+ ratio was assessed by inter-group comparisons and Spearman correlation checking. P values of <0.05 were considered statistically significant in all analyses. For descriptive statistics of cell numbers, the percentile ranges were also used because of non-normal variables distributions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled short-term clinical trial
| Arm | Type | Receives |
|---|---|---|
| Az group | Experimental | Drug: Az+SRPPeriodontitis patients, who underwent scaling and root planning (SRP) as one-stage full-mouth disinfection procedure and additionally received oral azithromycin ("Health" Pharmaceutical Company, Kharkiv, Ukraine) in a dose of 500 mg q.d. for 7 days, then 500 mg q.w. for the next 3 weeks |
| SRP group | Active comparator | Drug: SRPPeriodontitis patients who underwent scaling and root planning (SRP) as one-stage full-mouth disinfection procedure. |
| H group | Other | Drug: No interventionsReference group. 25 healthy volunteers who underwent only diagnostics to confirm the clinical healthy state of the gingiva |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of more than 20 teeth (for each tooth, the probing pocket depth ≤3 mm
- Absence of clinical gingival inflammation at intact or reduced periodontium
- The presence of at least 15 natural teeth, at least 10 sites with the periodontal pocket depth (PPD) ≥4 mm, and/or clinical attachment loss of ≥4 mm at the same site, and satisfactory general health
Key exclusion criteria (6 listed)
- Taking antibiotics or anti-inflammatory medications within the previous 3 months
- Periodontal therapy within the previous 6 months
- Purulent exudation from periodontal pockets
- Pregnancy or breastfeeding
- Severe, uncontrolled (decompensated) diseases of the internal organs, or neuropsychiatric disorders
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 |
|---|---|---|
| Az+SRPAlso: Azithromicyn groupAzithromycin as an adjunct to scaling and root planning in the treatment of periodontitis | Drug | Az group |
| SRPAlso: Periodontal conventional treatment groupScaling and root planning (SRP) treatment of periodontitis | Drug | SRP group |
| No interventionsAlso: Reference/periodontal health groupDiagnostocs to confirm the healthy state of the gingiva | Drug | H group |
Primary outcome
Change in clinical attachment loss (CAL)
Time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Mean CAL, measured at six periodontal sites around each tooth (including the third molars) to the nearest 1 mm
Change in periodontal pocket depth (PPD)
Time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Mean periodontal pocket depth, measured at six periodontal sites around each tooth (including the third molars) to the nearest 1 mm
7 secondary outcomes
Change in bleeding on probing (BOP)
Time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in density of CD68+ macrophages
Time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in density of CD163+ macrophages
Time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in mean level of IL1-β in periodontitis-affected gingiva
Time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in mean level of IL-6 in periodontitis-affected gingiva
Time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in mean level of IL-10 in periodontitis-affected gingiva
Time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
Change in mean level of TGF-β in periodontitis-affected gingiva
Time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP
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 31 Oct 2023.
- Background: PubMed 33413320Morales A, Contador R, Bravo J, Carvajal P, Silva N, Strauss FJ, Gamonal J. Clinical effects of probiotic or azithromycin as an adjunct to scaling and root planning in the treatment of stage III periodontitis: a pilot randomized controlled clinical trial. BMC Oral Health. 2021 Jan 7;21(1):12. doi: 10.1186/s12903-020-01276-3.
- Background: PubMed 3860518Haffajee AD, Socransky SS, Ebersole JL. Survival analysis of periodontal sites before and after periodontal therapy. J Clin Periodontol. 1985 Aug;12(7):553-67. doi: 10.1111/j.1600-051x.1985.tb01389.x.
- Background: PubMed 25762997Mills CD, Lenz LL, Ley K. Macrophages at the fork in the road to health or disease. Front Immunol. 2015 Feb 16;6:59. doi: 10.3389/fimmu.2015.00059. eCollection 2015. No abstract available.
- Background: PubMed 30285304Zhou LN, Bi CS, Gao LN, An Y, Chen F, Chen FM. Macrophage polarization in human gingival tissue in response to periodontal disease. Oral Dis. 2019 Jan;25(1):265-273. doi: 10.1111/odi.12983. Epub 2018 Oct 12.
- Background: PubMed 29319160Shapouri-Moghaddam A, Mohammadian S, Vazini H, Taghadosi M, Esmaeili SA, Mardani F, Seifi B, Mohammadi A, Afshari JT, Sahebkar A. Macrophage plasticity, polarization, and function in health and disease. J Cell Physiol. 2018 Sep;233(9):6425-6440. doi: 10.1002/jcp.26429. Epub 2018 Mar 1.
- Background: PubMed 21883359Allam JP, Duan Y, Heinemann F, Winter J, Gotz W, Deschner J, Wenghoefer M, Bieber T, Jepsen S, Novak N. IL-23-producing CD68(+) macrophage-like cells predominate within an IL-17-polarized infiltrate in chronic periodontitis lesions. J Clin Periodontol. 2011 Oct;38(10):879-86. doi: 10.1111/j.1600-051X.2011.01752.x. Epub 2011 Aug 31.
- Background: PubMed 16164022Fabriek BO, Dijkstra CD, van den Berg TK. The macrophage scavenger receptor CD163. Immunobiology. 2005;210(2-4):153-60. doi: 10.1016/j.imbio.2005.05.010.
- Background: PubMed 24631273Parnham MJ, Erakovic Haber V, Giamarellos-Bourboulis EJ, Perletti G, Verleden GM, Vos R. Azithromycin: mechanisms of action and their relevance for clinical applications. Pharmacol Ther. 2014 Aug;143(2):225-45. doi: 10.1016/j.pharmthera.2014.03.003. Epub 2014 Mar 11.
- Background: PubMed 24861402Fujise O, Miura M, Hamachi T, Aida Y, Nishimura F. Regenerative effect of azithromycin on periodontitis with different levels of gingival inflammation: three case reports. Aust Dent J. 2014 Jun;59(2):245-51. doi: 10.1111/adj.12177.
- Background: PubMed 25541821Nepokupnaia-Slobodianuk TS, Skripnikov PN. [The clinical effectiveness of long-term azithromycin in patients with chronic generalized periodontitis]. Georgian Med News. 2014 Nov;(236):27-31. Russian.
- Background: PubMed 17022821Hai R, Chu A, Li H, Umamoto S, Rider P, Liu F. Infection of human cytomegalovirus in cultured human gingival tissue. Virol J. 2006 Oct 5;3:84. doi: 10.1186/1743-422X-3-84.
- Background: PubMed 31912527Loos BG, Needleman I. Endpoints of active periodontal therapy. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):61-71. doi: 10.1111/jcpe.13253.
- Individual participant dataSharing planned: No. We plan to provide all the necessary data in a future article.
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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.
Igor P. Kaidashev, MD principal investigator
Ukrainian Medical Stomatological Academy Poltava, Ukraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Az+SRP and SRP in people with Periodontitis, run by Ukrainian Medical Stomatological Academy at 1 site in Ukraine.
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 3 inclusion and 6 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 31 Oct 2023. 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 Ukraine. 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.
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 clinical attachment loss (CAL) (time frame: The pre-treatment stage (T0) and 4 weeks ±5 days after the completion of SRP). The study lists 2 primary outcomes in all. 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 NCT05506371, which also lists 15 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 31 Oct 2023.