Correlation Between Peri-implantitis and Assumptions of Medications
NCT ID: NCT04783974
Last Updated: 2022-05-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
270 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-02-15
Study Completion Date
2021-06-20
Brief Summary
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The aim of the study is to investigate the correlation between the assumption of systemic medications (such as SSRI, PPI, anti-inflammatory drugs and anti-hypertensive drugs) and the failure of dental implant therapy in terms of occurrence peri-implantitis and/or implant failure.
The clinical records of all subjects treated with dental implants during the period between January 1st, 2005, and December 31st, 2020 in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion.
Inclusion criteria: i) subjects who were 18 years old or older at the time of intervention; ii) subjects who provided their informed consent for the intervention iii) patients with total or partial edentulism treated with dental implants; iv) patients with at least 6 months follow-up, beginning from the date of placement of the prosthesis.
Exclusion criteria: i) incomplete data (e.g. absence of periapical radiographs) Descriptive statistics will be provided by means of mean values and standard deviations. Correlation between baseline parameters and outcomes will be provided through logistic regression. Survival tables and Kaplan-Meier analysis will be elaborated for survival analysis, considering the occurrence of implant failure and the diagnosis of peri-implantitis as events. Cox regression analysis will be used in order to evaluate the influence of the use of each drug on survival curves.
The level of significance was set at p\<0.05. The sample size was calculated in order to evaluate the hazard risk of patients exposed to each specific drug (SSRI, PPI, Anti-inflammatory drugs or anti-hypertensive) compared to non-exposed patients. The ratio of exposed/non-exposed patients is expected to be 1:4 in the cohort. On the basis of a hypothesized 5-year incidence of peri-implantitis of 0.16, HR = 2, and a 10% dropout rate, the sample should be made of 358 subjects (72 exposed + 286 not exposed).
The clinical records of all subjects treated with dental implants during the period between January 1st, 2005, and December 31st, 2020 in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion.
Inclusion criteria: i) subjects who were 18 years old or older at the time of intervention; ii) subjects who provided their informed consent for the intervention iii) patients with total or partial edentulism treated with dental implants; iv) patients with at least 6 months follow-up, beginning from the date of placement of the prosthesis.
Exclusion criteria: i) incomplete data (e.g. absence of periapical radiographs) Descriptive statistics will be provided by means of mean values and standard deviations. Correlation between baseline parameters and outcomes will be provided through logistic regression. Survival tables and Kaplan-Meier analysis will be elaborated for survival analysis, considering the occurrence of implant failure and the diagnosis of peri-implantitis as events. Cox regression analysis will be used in order to evaluate the influence of the use of each drug on survival curves.
The level of significance was set at p\<0.05. The sample size was calculated in order to evaluate the hazard risk of patients exposed to each specific drug (SSRI, PPI, Anti-inflammatory drugs or anti-hypertensive) compared to non-exposed patients. The ratio of exposed/non-exposed patients is expected to be 1:4 in the cohort. On the basis of a hypothesized 5-year incidence of peri-implantitis of 0.16, HR = 2, and a 10% dropout rate, the sample should be made of 358 subjects (72 exposed + 286 not exposed).
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Detailed Description
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Global demographic trends clearly show the increase in life expectancy and, as a direct consequence of progressive aging, the prevalence of disabling diseases with the relative intake of drugs. The intake of drugs such as thiazide diuretics, beta-blockers, anti-inflammatories, proton pump inhibitors and serotonin re-uptake inhibitors has been shown to be able to modulate bone metabolism with different mechanisms. Thus, they may be able to influence peri-implant health.
Proton pump blockers (PPIs) are a class of gastric acid secretion inhibitors that are currently among the best-selling drugs worldwide. The use of PPIs, especially at high doses and/or in long-term treatments, has been associated to an increased risk of hip, wrist and spine fractures. Different mechanisms have been suggested to explain the effects of PPIs on bone metabolism, which include: reduction of calcium absorption due to an increased pH in the small intestine; reduction of the osteoclastic resorption activity due to the modulation of vacuolar ATPase (V-ATPase) at the membrane level in the vesicles of osteoclasts; inhibition of non-specific alkaline phosphatase (ALP) and FOSFO1 in the vesicles of the bone matrix, increasing the expression of osteocalcin and the osteoprotegerin/RANKL ratio.
Selective serotonin reuptake inhibitors (SSRIs) are currently among the most common antidepressants and their main indications are major depression, generalized anxiety disorder, post-traumatic stress disorder, obsessive compulsive disorder, panic attack syndrome and bulimia. The action of selective serotonin reuptake inhibitors (SSRIs) on certain receptors and transporters such as 5-HT1B, 5-HT2B or 5-HT2C can result in impaired bone metabolism through increased differentiation and activation of osteoclasts. Reductions in bone mineral density (BMD) have been described, among others, in patients suffering from depressive syndromes which appear to be related to alterations in serotonin function. These findings suggest the hypothesis that SSRIs may have an impact also on the osseointegration process.
Anti-hypertensive drugs medications have been proven to interfere with bone metabolism through different mechanisms. For example, beta-blockers and angiotensin-converting enzyme inhibitors are able to inhibit osteoclasts activity by blocking the surface β-2 adrenergic receptors, which affects the renin-angiotensin system, while thiazides may enhance bone formation by increasing calcium absorption at the distal convoluted tubule.
Systemic corticosteroids are associated to various adverse reactions, especially when used at high doses or for long periods. Fracture and osteoporosis are among the most common corticosteroid-related adverse events.
The mechanism through which NSAIDs may negatively affect bone healing has not been fully explained, but it seems to be mostly related to the COX-2 blockade. Actually, it was proven that COX-2 is necessary for mesenchymal cells to differentiate into osteoblasts during fracture healing, while cele-coxib and other COX-2 blockers were reported to have a negative effect on the healing process by limiting osteogenesis and decreasing the osteogenic potential of mesenchymal stem cells.
The main aim of the study is to investigate if the systemic assumption of medications (such as SSRIs, PPIs, anti-inflammatory drugs, and anti-hypertensive drugs) could imply an increased risk of developing peri-implantitis.
Secondary aims will be to evaluate:
* the augmented risk of implant failure correlated to the assumption of drugs
* the correlation between the use of drugs and implant cumulative survival rate (CSR%)
* the relationship between drug dosage and the development of peri-implantitis
* relationship between drug dosage and implant failure The present will be a single-center, retrospective, observational, comparative study.
The definition of implant survival will be based on the fact that the implant is still in situ, stable, and supporting a functional prosthesis. An implant that was removed or spontaneously lost due to failed osseointegration will be considered an implant failure. Peri-implantitis will be defined according to the following parameters: 1) presence of bleeding and/or suppuration on gentle probing; 2) presence of radiographic bone loss of at least 2 mm, beyond crestal bone level changes due to initial bone remodeling, evaluated through comparison of baseline (one year after surgical intervention) and follow-up periapical radiographs; in absence of baseline periapical radiographs, presence of bone level located ≥ 3 mm apical to the most coronal portion of the intraosseous portion of the implant; 3) presence of an increased probing depth as compared to previous observations.
The following parameters will be collected from clinical records:
* Patient's age and sex at the time of surgical intervention
* description of systemic diseases (if any) at the time of surgical intervention
* description of pharmacological therapy (if any) at the time of surgical intervention
* smoking status (number of cigarettes (if reported)) at the time of surgical intervention
* history of periodontal disease before the surgical intervention or at the time of surgical intervention
* date of surgery
* implant position
* implant brand and type, diameter, length, diameter of the prosthetic platform
* characteristics of the bone regeneration procedure (if performed)
* description of surgical complications (if any)
* characteristics and timing of prosthetic rehabilitation (provisional and definitive)
* date of the last clinical control
* date of the last radiographic control
* failure occurrence date (if any)
* peri-implantitis occurrence date (if any)
* oral hygiene level
* frequency of maintenance recall sessions
Data collection will be performed in a maximum period of 5 months. Data analysis will take a maximum of 4 months, for a total duration of 9 months. The collected data refer to clinical records of patients treated with implants from January 1st, 2005 to June 30th, 2020 (last follow-up included: 6 month visit on December 2020).
The sample size was calculated in order to evaluate the hazard risk of patients exposed to a specific drug (SSRI, PPI, Anti-inflammatory drugs or anti-hypertensive) compared to non-exposed patients. The ratio of exposed/non-exposed patients is expected to be 1:4 in the cohort. The 5-year incidence in non-exposed patients in a previous series of cases resulted 0.16, and an HR=2 is expected in the exposed patients. On the basis of these assumptions, considering a 10% dropout rate, the sample should be made of 358 subjects (72 exposed + 286 not exposed ).
Therefore, a total of 358 patients who was exposed at least to one of the study drugs will be included: each subject will be evaluated both in the test group of the exposure drug (vs the group of subjects who did not take that drug), and in the control group for the drugs that he/she has not taken.
The calculation was performed using the method proposed by Schoenfeld. Descriptive statistics will be provided by means of mean values and standard deviations. Correlation between baseline parameters and outcomes will be provided through the use of logistic regression. Survival tables and Kaplan-Meier analysis will be elaborated for survival analysis, considering the occurrence of implant failure and the diagnosis of peri-implantitis as events. Cox regression analysis will be used in order to evaluate the influence of the use of SSRI and/or PPI on survival curves.
For all the analysis, the level of significance was set at p\<0.05.
Proton pump blockers (PPIs) are a class of gastric acid secretion inhibitors that are currently among the best-selling drugs worldwide. The use of PPIs, especially at high doses and/or in long-term treatments, has been associated to an increased risk of hip, wrist and spine fractures. Different mechanisms have been suggested to explain the effects of PPIs on bone metabolism, which include: reduction of calcium absorption due to an increased pH in the small intestine; reduction of the osteoclastic resorption activity due to the modulation of vacuolar ATPase (V-ATPase) at the membrane level in the vesicles of osteoclasts; inhibition of non-specific alkaline phosphatase (ALP) and FOSFO1 in the vesicles of the bone matrix, increasing the expression of osteocalcin and the osteoprotegerin/RANKL ratio.
Selective serotonin reuptake inhibitors (SSRIs) are currently among the most common antidepressants and their main indications are major depression, generalized anxiety disorder, post-traumatic stress disorder, obsessive compulsive disorder, panic attack syndrome and bulimia. The action of selective serotonin reuptake inhibitors (SSRIs) on certain receptors and transporters such as 5-HT1B, 5-HT2B or 5-HT2C can result in impaired bone metabolism through increased differentiation and activation of osteoclasts. Reductions in bone mineral density (BMD) have been described, among others, in patients suffering from depressive syndromes which appear to be related to alterations in serotonin function. These findings suggest the hypothesis that SSRIs may have an impact also on the osseointegration process.
Anti-hypertensive drugs medications have been proven to interfere with bone metabolism through different mechanisms. For example, beta-blockers and angiotensin-converting enzyme inhibitors are able to inhibit osteoclasts activity by blocking the surface β-2 adrenergic receptors, which affects the renin-angiotensin system, while thiazides may enhance bone formation by increasing calcium absorption at the distal convoluted tubule.
Systemic corticosteroids are associated to various adverse reactions, especially when used at high doses or for long periods. Fracture and osteoporosis are among the most common corticosteroid-related adverse events.
The mechanism through which NSAIDs may negatively affect bone healing has not been fully explained, but it seems to be mostly related to the COX-2 blockade. Actually, it was proven that COX-2 is necessary for mesenchymal cells to differentiate into osteoblasts during fracture healing, while cele-coxib and other COX-2 blockers were reported to have a negative effect on the healing process by limiting osteogenesis and decreasing the osteogenic potential of mesenchymal stem cells.
The main aim of the study is to investigate if the systemic assumption of medications (such as SSRIs, PPIs, anti-inflammatory drugs, and anti-hypertensive drugs) could imply an increased risk of developing peri-implantitis.
Secondary aims will be to evaluate:
* the augmented risk of implant failure correlated to the assumption of drugs
* the correlation between the use of drugs and implant cumulative survival rate (CSR%)
* the relationship between drug dosage and the development of peri-implantitis
* relationship between drug dosage and implant failure The present will be a single-center, retrospective, observational, comparative study.
The definition of implant survival will be based on the fact that the implant is still in situ, stable, and supporting a functional prosthesis. An implant that was removed or spontaneously lost due to failed osseointegration will be considered an implant failure. Peri-implantitis will be defined according to the following parameters: 1) presence of bleeding and/or suppuration on gentle probing; 2) presence of radiographic bone loss of at least 2 mm, beyond crestal bone level changes due to initial bone remodeling, evaluated through comparison of baseline (one year after surgical intervention) and follow-up periapical radiographs; in absence of baseline periapical radiographs, presence of bone level located ≥ 3 mm apical to the most coronal portion of the intraosseous portion of the implant; 3) presence of an increased probing depth as compared to previous observations.
The following parameters will be collected from clinical records:
* Patient's age and sex at the time of surgical intervention
* description of systemic diseases (if any) at the time of surgical intervention
* description of pharmacological therapy (if any) at the time of surgical intervention
* smoking status (number of cigarettes (if reported)) at the time of surgical intervention
* history of periodontal disease before the surgical intervention or at the time of surgical intervention
* date of surgery
* implant position
* implant brand and type, diameter, length, diameter of the prosthetic platform
* characteristics of the bone regeneration procedure (if performed)
* description of surgical complications (if any)
* characteristics and timing of prosthetic rehabilitation (provisional and definitive)
* date of the last clinical control
* date of the last radiographic control
* failure occurrence date (if any)
* peri-implantitis occurrence date (if any)
* oral hygiene level
* frequency of maintenance recall sessions
Data collection will be performed in a maximum period of 5 months. Data analysis will take a maximum of 4 months, for a total duration of 9 months. The collected data refer to clinical records of patients treated with implants from January 1st, 2005 to June 30th, 2020 (last follow-up included: 6 month visit on December 2020).
The sample size was calculated in order to evaluate the hazard risk of patients exposed to a specific drug (SSRI, PPI, Anti-inflammatory drugs or anti-hypertensive) compared to non-exposed patients. The ratio of exposed/non-exposed patients is expected to be 1:4 in the cohort. The 5-year incidence in non-exposed patients in a previous series of cases resulted 0.16, and an HR=2 is expected in the exposed patients. On the basis of these assumptions, considering a 10% dropout rate, the sample should be made of 358 subjects (72 exposed + 286 not exposed ).
Therefore, a total of 358 patients who was exposed at least to one of the study drugs will be included: each subject will be evaluated both in the test group of the exposure drug (vs the group of subjects who did not take that drug), and in the control group for the drugs that he/she has not taken.
The calculation was performed using the method proposed by Schoenfeld. Descriptive statistics will be provided by means of mean values and standard deviations. Correlation between baseline parameters and outcomes will be provided through the use of logistic regression. Survival tables and Kaplan-Meier analysis will be elaborated for survival analysis, considering the occurrence of implant failure and the diagnosis of peri-implantitis as events. Cox regression analysis will be used in order to evaluate the influence of the use of SSRI and/or PPI on survival curves.
For all the analysis, the level of significance was set at p\<0.05.
Conditions
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Peri-Implantitis
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
RETROSPECTIVE
Study Groups
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Patients assuming SSRI
Patients treated with dental implants and assuming selective serotonin reuptake inhibitors
Dental implants
Intervention Type
DEVICE
Treatment of total or partial edentulism through the placement of osseointegrated dental implants
Patients assuming PPI
Patients treated with dental implants and assuming proton pump blockers
Dental implants
Intervention Type
DEVICE
Treatment of total or partial edentulism through the placement of osseointegrated dental implants
Patients assuming Anti-inflammatory drugs
Patients treated with dental implants and assuming anti-inflammatory drugs
Dental implants
Intervention Type
DEVICE
Treatment of total or partial edentulism through the placement of osseointegrated dental implants
Patients assuming Anti-hypertensive drugs
Patients treated with dental implants and assuming anti-hypertensive drugs
Dental implants
Intervention Type
DEVICE
Treatment of total or partial edentulism through the placement of osseointegrated dental implants
Control group - Patients not assuming the studied drugs
Patients treated with dental implants and not assuming any of the following drugs: selective serotonin reuptake inhibitors, proton pump blockers, anti-inflammatory drugs, anti-hypertensive drugs
Dental implants
Intervention Type
DEVICE
Treatment of total or partial edentulism through the placement of osseointegrated dental implants
Interventions
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Dental implants
Treatment of total or partial edentulism through the placement of osseointegrated dental implants
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* subjects who were 18 years old or older at the time of intervention
* subjects who provided their informed consent for the intervention
* patients with total or partial edentulism treated with dental implants
* patients with at least 6 months follow-up, beginning from the date of placement of the prosthesis.
* subjects who provided their informed consent for the intervention
* patients with total or partial edentulism treated with dental implants
* patients with at least 6 months follow-up, beginning from the date of placement of the prosthesis.
Exclusion Criteria
* Incomplete data (e.g. absence of periapical radiographs)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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IRCCS Istituto Ortopedico Galeazzi
Milan, , Italy
Site Status
Countries
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Italy
References
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Mombelli A, Cionca N. Systemic diseases affecting osseointegration therapy. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:97-103. doi: 10.1111/j.1600-0501.2006.01354.x.
Reference Type
BACKGROUND
Donos N, Calciolari E. Dental implants in patients affected by systemic diseases. Br Dent J. 2014 Oct;217(8):425-30. doi: 10.1038/sj.bdj.2014.911.
Reference Type
BACKGROUND
Vestergaard P. Skeletal effects of central nervous system active drugs: anxiolytics, sedatives, antidepressants, lithium and neuroleptics. Curr Drug Saf. 2008 Sep;3(3):185-9. doi: 10.2174/157488608785699432.
Reference Type
BACKGROUND
Brater DC. Update in diuretic therapy: clinical pharmacology. Semin Nephrol. 2011 Nov;31(6):483-94. doi: 10.1016/j.semnephrol.2011.09.003.
Reference Type
BACKGROUND
Gasiorowska A, Fass R. The proton pump inhibitor (PPI) test in GERD: does it still have a role? J Clin Gastroenterol. 2008 Sep;42(8):867-74. doi: 10.1097/MCG.0b013e31816c47ed.
Reference Type
BACKGROUND
Ye X, Liu H, Wu C, Qin Y, Zang J, Gao Q, Zhang X, He J. Proton pump inhibitors therapy and risk of hip fracture: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2011 Sep;23(9):794-800. doi: 10.1097/MEG.0b013e328348a56a.
Reference Type
BACKGROUND
Yu EW, Blackwell T, Ensrud KE, Hillier TA, Lane NE, Orwoll E, Bauer DC. Acid-suppressive medications and risk of bone loss and fracture in older adults. Calcif Tissue Int. 2008 Oct;83(4):251-9. doi: 10.1007/s00223-008-9170-1. Epub 2008 Sep 24.
Reference Type
BACKGROUND
Mattsson JP, Vaananen K, Wallmark B, Lorentzon P. Omeprazole and bafilomycin, two proton pump inhibitors: differentiation of their effects on gastric, kidney and bone H(+)-translocating ATPases. Biochim Biophys Acta. 1991 Jun 18;1065(2):261-8. doi: 10.1016/0005-2736(91)90238-4.
Reference Type
BACKGROUND
Roberts S, Narisawa S, Harmey D, Millan JL, Farquharson C. Functional involvement of PHOSPHO1 in matrix vesicle-mediated skeletal mineralization. J Bone Miner Res. 2007 Apr;22(4):617-27. doi: 10.1359/jbmr.070108.
Reference Type
BACKGROUND
Delomenede M, Buchet R, Mebarek S. Lansoprazole is an uncompetitive inhibitor of tissue-nonspecific alkaline phosphatase. Acta Biochim Pol. 2009;56(2):301-5. Epub 2009 Jun 18.
Reference Type
BACKGROUND
Mizunashi K, Furukawa Y, Katano K, Abe K. Effect of omeprazole, an inhibitor of H+,K(+)-ATPase, on bone resorption in humans. Calcif Tissue Int. 1993 Jul;53(1):21-5. doi: 10.1007/BF01352010.
Reference Type
BACKGROUND
Costa-Rodrigues J, Reis S, Teixeira S, Lopes S, Fernandes MH. Dose-dependent inhibitory effects of proton pump inhibitors on human osteoclastic and osteoblastic cell activity. FEBS J. 2013 Oct;280(20):5052-64. doi: 10.1111/febs.12478. Epub 2013 Sep 5.
Reference Type
BACKGROUND
Rodan GA, Martin TJ. Therapeutic approaches to bone diseases. Science. 2000 Sep 1;289(5484):1508-14. doi: 10.1126/science.289.5484.1508.
Reference Type
BACKGROUND
Haney EM, Warden SJ. Skeletal effects of serotonin (5-hydroxytryptamine) transporter inhibition: evidence from clinical studies. J Musculoskelet Neuronal Interact. 2008 Apr-Jun;8(2):133-45.
Reference Type
BACKGROUND
Schweiger U, Weber B, Deuschle M, Heuser I. Lumbar bone mineral density in patients with major depression: evidence of increased bone loss at follow-up. Am J Psychiatry. 2000 Jan;157(1):118-20. doi: 10.1176/ajp.157.1.118.
Reference Type
BACKGROUND
Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clin Ther. 2017 Nov;39(11):2216-2229. doi: 10.1016/j.clinthera.2017.09.011. Epub 2017 Oct 19.
Reference Type
BACKGROUND
Lisowska B, Kosson D, Domaracka K. Positives and negatives of nonsteroidal anti-inflammatory drugs in bone healing: the effects of these drugs on bone repair. Drug Des Devel Ther. 2018 Jun 21;12:1809-1814. doi: 10.2147/DDDT.S164565. eCollection 2018.
Reference Type
BACKGROUND
Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SC-AA-2
Identifier Type: -
Identifier Source: org_study_id
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