Peri-ImplantitisNCT05724706
An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
An observational study of Peri-Implantitis and Bone Loss in Jaw, run by Biruni University.
Trial summary
Objectives: Inflammatory lesions develop in the tissues surrounding implants are referred to as peri-implant diseases. Oxidants, play a role in inflammatory lesions. The study aimed to determine oxidant and antioxidant levels in the saliva of patients with various levels of peri-implant diseases and the relationship… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Bone Loss in Jaw, Dental Implant Failed
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 13 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: Patients with peri-implantitis (PI); The PI group consisted of 23 patients (9M/14F) with ages ranging from 29 to 66 years Group 2: Patients with marginal bone loss (MBL); The MBL group consisted of 22 patients (14M /8F) aged between 27 and 67 years Group 3: Patients with healthy peri-implant tissues (HI); The HI group consisted of 22 patients(7M/15F) with ages ranging from 29 to 62 years Group 4: Healthy control (HC) 21 individuals (8M/ 13F) whose ages ranged between 27 and 67 years
Who may be able to join
- Adults aged 18 and older;
- Being systemically healthy; ,
- Being non-smokers;
- For dental implant groups, at least 1 osseointegrated implant;
- Dental implant applied by at least a specialist-level physician;
- Dental implants having the same surface and the same design;
- Correct prosthetic restoration of occlusal loading;
- Dental implant having been in function for at least 6 months.
Who cannot join
- Any history of medical conditions;
- Presence of active periodontal disease;
- Use of antibiotic or anti-inflammatory medications in the past 3 months;
- Pregnancy;
- Use of AO supplements;
- Smoking;
Show all 10Show fewer
- Poor oral hygiene;
- Inflammation in the oral area;
- Presence of active caries;
- Presence of oral mucosal lesions such as oral lichen planus or recurrent aphthous stomatitis.
About this study
Objectives: Inflammatory lesions develop in the tissues surrounding implants are referred to as peri-implant diseases. Oxidants, play a role in inflammatory lesions. The study aimed to determine oxidant and antioxidant levels in the saliva of patients with various levels of peri-implant diseases and the relationship between oxidative stress and peri-implant diseases.
Material and methods: Sixty-seven patients with at least one dental implant applied in our clinic were included in the study. The patients were divided into 3 groups; with peri-implantitis (PI), with marginal bone loss (MBL) and with healthy peri-implant (HI) tissues. Twenty-one individuals who didn't have any dental implants were included the study as a healthy control group (HC). For oxidant concentration, total oxidant status (TOS), advanced oxidation protein products (AOPP), and for antioxidant concentration, total antioxidant status (TAS), were investigated.
Read the detailed description
INTRODUCTION
Inflammatory lesions that develop in the tissues surrounding implants are generally referred to as peri-implant diseases. Peri-implant disease has two subgroups; peri-implant mucositis, which is reversible inflammatory lesion limited to the surrounding mucosal tissues, and peri-impantitis which is characterized by bone destruction around the dental implants. Peri-implant disease develops as a result of a balance problem between bacterial loading and host response around an implant that has been correctly secured by osseointegration. Bacteria produce tissue destruction directly, via toxic products, and indirectly, by activating host defense systems; in other words, by inflammation. Various types of molecules are formed in inflammatory lesions; these include reactive species such as free radicals (FR) and reactive oxygen species (ROS). ROS are physiological formations that are the endogenous sources of the mitochondrial electron transport chain seen in every living organism. ROS occur as a natural product of normal oxygen metabolism, and play an important role in cell signals and hemostasis. ROS increase during inflammation; hence, oxidizing conditions increase and cell structures are damaged. This condition is known as oxidative stress (OS). OS depends on an increase in FR production and/or a decrease in the protective mechanism (antioxidant status), and OS is defined as a balance problem between oxidants and antioxidants in the body.
Many studies support the idea that OS plays an important role in the etiology and severity of periodontal diseases.
The etiology and the pathogenic mechanism are similar in the periodontitis and peri-implant diseases processes. However, those studies indicating the effect of OS on peri-implant tissues have used quite small groups or small numbers of biomarkers. The results obtained have been contradictory.
Therefore, this study aimed to determine oxidant and antioxidant levels in the saliva of patients with various levels of peri-implant diseases and the relationship between oxidative stress and peri-implant diseases.
- Conditions
- Peri-Implantitis, Bone Loss in Jaw, Dental Implant Failed, Dental Implant Failure Nos, Oxidative Stress
- Keywords
- oxidant, antioxidant, oxidative stress, Peri-implantitis, Marginal bone loss
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with peri-implantitis (PI) | The PI group consisted of 23 patients (9M/14F) with ages ranging from 29 to 66 years (mean 51,91 ± 10,63). This group was selected based on the success criteria of Misch et al. 2008; patients with clinical findings such as bleeding and/or sweeping in their implants, pain or tenderness during function, and exudation in peri-implant tissues, with at least 1 implant with a pocket depth of more than 7 mm and radiographic bone loss of at least 4 mm or more around the implant were included. | |
| Patients with marginal bone loss (MBL) | The MBL group consisted of 22 patients (14M /8F) aged between 27 and 67 years (mean 53,00 ± 8,92). This group was based on the success criteria defined by Misch et al. 2008; patients for whom, in the clinical examination of implants, there was no bleeding, non-sweeping, non-mobility, with no exudation history of peri-implant tissues, no pain or sensitivity when in function, and there was at least 1 implant with 2-4 mm radiographic bone loss around the implant were included. | |
| Patients with healthy peri-implant tissues (HI) | The HI group consisted of 22 patients(7M/15F) with ages ranging from 29 to 62 years (mean 51,00 ± 8,45). This group was based on the success criteria defined by Misch et al. in 2008: Patients with no history of exudation in the periimplant tissues, no bleeding and suppuration during probing, no pain or sensitivity in function, no mobility, and at least 1 implant with a radiographic bone loss around the implant of less than 2 mm were included. | |
| Healthy control (HC) | 21 individuals (8M/ 13F) whose ages ranged between 27 and 67 (mean 21.88 ± 11.21 years), who did not have any dental implants, and who were selected among the patient community were included the study as a healthy control group (HC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying patients to be included in the study and collecting saliva samples
Patients to be included in the study were determined by clinical and radiological examinations, divided into groups, and saliva samples; it was collected to measure the total oxidant status (TOS) and advanced oxidation protein products (AOPP) to evaluate the oxidant concentration in it, and the total antioxidant status (TAS) to evaluate the antioxidant concentration in it and stored at -80 degrees Celsius.
Measured: 1 year
Secondary outcomes (1)
Biochemical examination of oxidant and antioxidant biomarkers in saliva and statistical evaluation of the results
In biochemical analysis, For oxidant concentration in saliva, total oxidant status (TOS), advanced oxidation protein products (AOPP), and for antioxidant concentration, total antioxidant status (TAS), were investigated. The values of markers whose biochemical analysis were made in saliva were statistically analyzed and calculated.
Saliva TOS levels were reported as µM H2O2 equivalent per liter (µmol H2O2 Equiv/L).
Saliva AOPP levels were reported as nmol / mL chloramine-T equivalent. Saliva TAS levels were reported as units of mM trolox equivalent per liter (mmol trolox Equiv/L).
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Sep 2016
- Primary completion5 Jan 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University, Istanbul Arel University
- Responsible party
- Principal investigator, Zeynep Seda Pekcetin-Bayav, Biruni University
- Investigators
- ZEYNEP S PEKCETIN-BAYAV, ASST. PROF., Study director, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724706
- Sponsor's protocol ID
- Z PEKCETIN-BAYAV
- Status last verified
- Feb 2023
- First submitted
- 22 Mar 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be available when needed.
Publications
Berglundh T, Persson L, Klinge B. A systematic review of the incidence of biological and technical complications in implant dentistry reported in prospective longitudinal studies of at least 5 years. J Clin Periodontol. 2002;29 Suppl 3:197-212; discussion 232-3. doi: 10.1034/j.1600-051x.29.s3.12.x.
PubMed 12787220Canakci CF, Cicek Y, Canakci V. Reactive oxygen species and human inflammatory periodontal diseases. Biochemistry (Mosc). 2005 Jun;70(6):619-28. doi: 10.1007/s10541-005-0161-9.
PubMed 16038603Chapple IL. Role of free radicals and antioxidants in the pathogenesis of the inflammatory periodontal diseases. Clin Mol Pathol. 1996 Oct;49(5):M247-55. doi: 10.1136/mp.49.5.m247. No abstract available.
PubMed 16696085Chapple IL. Reactive oxygen species and antioxidants in inflammatory diseases. J Clin Periodontol. 1997 May;24(5):287-96. doi: 10.1111/j.1600-051x.1997.tb00760.x.
PubMed 9178107Chapple IL, Brock G, Eftimiadi C, Matthews JB. Glutathione in gingival crevicular fluid and its relation to local antioxidant capacity in periodontal health and disease. Mol Pathol. 2002 Dec;55(6):367-73. doi: 10.1136/mp.55.6.367.
PubMed 12456773Chapple IL, Brock GR, Milward MR, Ling N, Matthews JB. Compromised GCF total antioxidant capacity in periodontitis: cause or effect? J Clin Periodontol. 2007 Feb;34(2):103-10. doi: 10.1111/j.1600-051X.2006.01029.x. Epub 2006 Dec 13.
PubMed 17214737Chapple IL, Matthews JB. The role of reactive oxygen and antioxidant species in periodontal tissue destruction. Periodontol 2000. 2007;43:160-232. doi: 10.1111/j.1600-0757.2006.00178.x. No abstract available.
PubMed 17214840Chapple IL, Milward MR, Ling-Mountford N, Weston P, Carter K, Askey K, Dallal GE, De Spirt S, Sies H, Patel D, Matthews JB. Adjunctive daily supplementation with encapsulated fruit, vegetable and berry juice powder concentrates and clinical periodontal outcomes: a double-blind RCT. J Clin Periodontol. 2012 Jan;39(1):62-72. doi: 10.1111/j.1600-051X.2011.01793.x. Epub 2011 Oct 17.
PubMed 22093005Chen AF, Chen DD, Daiber A, Faraci FM, Li H, Rembold CM, Laher I. Free radical biology of the cardiovascular system. Clin Sci (Lond). 2012 Jul;123(2):73-91. doi: 10.1042/CS20110562.
PubMed 22455351Edgar WM. Saliva: its secretion, composition and functions. Br Dent J. 1992 Apr 25;172(8):305-12. doi: 10.1038/sj.bdj.4807861.
PubMed 1591115Erel O. A novel automated direct measurement method for total antioxidant capacity using a new generation, more stable ABTS radical cation. Clin Biochem. 2004 Apr;37(4):277-85. doi: 10.1016/j.clinbiochem.2003.11.015.
PubMed 15003729Erel O. A new automated colorimetric method for measuring total oxidant status. Clin Biochem. 2005 Dec;38(12):1103-11. doi: 10.1016/j.clinbiochem.2005.08.008. Epub 2005 Oct 7.
PubMed 16214125Guo M, Liu L, Zhang J, Liu M. Role of Reactive Oxygen Species and Advanced Glycation End Products in the Malfunctioning of Dental Implants. West Indian Med J. 2015 Sep;64(4):419-23. doi: 10.7727/wimj.2014.105. Epub 2015 Apr 29.
PubMed 26624598Guncu GN, Tozum TF, Guncu MB, Yamalik N, Tumer C, Karabulut E, Kilinc K. Myeloperoxidase as a measure of polymorphonuclear leukocyte response in inflammatory status around immediately and delayed loaded dental implants: a randomized controlled clinical trial. Clin Implant Dent Relat Res. 2008 Mar;10(1):30-9. doi: 10.1111/j.1708-8208.2007.00058.x.
PubMed 18335584Hanasand M, Omdal R, Norheim KB, Goransson LG, Brede C, Jonsson G. Improved detection of advanced oxidation protein products in plasma. Clin Chim Acta. 2012 May 18;413(9-10):901-6. doi: 10.1016/j.cca.2012.01.038. Epub 2012 Feb 8.
PubMed 22336637
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
- ClinicalTrials.gov ID
- NCT05724706
- Acronym / sponsor ID
- Z PEKCETIN-BAYAV
- Conditions
- Peri-Implantitis, Bone Loss in Jaw, Dental Implant Failed, Dental Implant Failure Nos, Oxidative Stress
- Keywords
- oxidant, antioxidant, oxidative stress, Peri-implantitis, Marginal bone loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University, Istanbul Arel University
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 13 Feb 2023 (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.
Objectives: Inflammatory lesions develop in the tissues surrounding implants are referred to as peri-implant diseases. Oxidants, play a role in inflammatory lesions. The study aimed to determine oxidant and antioxidant levels in the saliva of patients with various levels of peri-implant diseases and the relationship between oxidative stress and peri-implant diseases.
Material and methods: Sixty-seven patients with at least one dental implant applied in our clinic were included in the study. The patients were divided into 3 groups; with peri-implantitis (PI), with marginal bone loss (MBL) and with healthy peri-implant (HI) tissues. Twenty-one individuals who didn't have any dental implants were included the study as a healthy control group (HC). For oxidant concentration, total oxidant status (TOS), advanced oxidation protein products (AOPP), and for antioxidant concentration, total antioxidant status (TAS), were investigated.
Detailed description
INTRODUCTION
Inflammatory lesions that develop in the tissues surrounding implants are generally referred to as peri-implant diseases. Peri-implant disease has two subgroups; peri-implant mucositis, which is reversible inflammatory lesion limited to the surrounding mucosal tissues, and peri-impantitis which is characterized by bone destruction around the dental implants. Peri-implant disease develops as a result of a balance problem between bacterial loading and host response around an implant that has been correctly secured by osseointegration. Bacteria produce tissue destruction directly, via toxic products, and indirectly, by activating host defense systems; in other words, by inflammation. Various types of molecules are formed in inflammatory lesions; these include reactive species such as free radicals (FR) and reactive oxygen species (ROS). ROS are physiological formations that are the endogenous sources of the mitochondrial electron transport chain seen in every living organism. ROS occur as a natural product of normal oxygen metabolism, and play an important role in cell signals and hemostasis. ROS increase during inflammation; hence, oxidizing conditions increase and cell structures are damaged. This condition is known as oxidative stress (OS). OS depends on an increase in FR production and/or a decrease in the protective mechanism (antioxidant status), and OS is defined as a balance problem between oxidants and antioxidants in the body.
Many studies support the idea that OS plays an important role in the etiology and severity of periodontal diseases.
The etiology and the pathogenic mechanism are similar in the periodontitis and peri-implant diseases processes. However, those studies indicating the effect of OS on peri-implant tissues have used quite small groups or small numbers of biomarkers. The results obtained have been contradictory.
Therefore, this study aimed to determine oxidant and antioxidant levels in the saliva of patients with various levels of peri-implant diseases and the relationship between oxidative stress and peri-implant diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with peri-implantitis (PI) | – | –The PI group consisted of 23 patients (9M/14F) with ages ranging from 29 to 66 years (mean 51,91 ± 10,63). This group was selected based on the success criteria of Misch et al. 2008; patients with clinical findings such as bleeding and/or sweeping in their implants, pain or tenderness during function, and exudation in peri-implant tissues, with at least 1 implant with a pocket depth of more than 7 mm and radiographic bone loss of at least 4 mm or more around the implant were included. |
| Patients with marginal bone loss (MBL) | – | –The MBL group consisted of 22 patients (14M /8F) aged between 27 and 67 years (mean 53,00 ± 8,92). This group was based on the success criteria defined by Misch et al. 2008; patients for whom, in the clinical examination of implants, there was no bleeding, non-sweeping, non-mobility, with no exudation history of peri-implant tissues, no pain or sensitivity when in function, and there was at least 1 implant with 2-4 mm radiographic bone loss around the implant were included. |
| Patients with healthy peri-implant tissues (HI) | – | –The HI group consisted of 22 patients(7M/15F) with ages ranging from 29 to 62 years (mean 51,00 ± 8,45). This group was based on the success criteria defined by Misch et al. in 2008: Patients with no history of exudation in the periimplant tissues, no bleeding and suppuration during probing, no pain or sensitivity in function, no mobility, and at least 1 implant with a radiographic bone loss around the implant of less than 2 mm were included. |
| Healthy control (HC) | – | –21 individuals (8M/ 13F) whose ages ranged between 27 and 67 (mean 21.88 ± 11.21 years), who did not have any dental implants, and who were selected among the patient community were included the study as a healthy control group (HC). |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Patients with peri-implantitis (PI); The PI group consisted of 23 patients (9M/14F) with ages ranging from 29 to 66 years Group 2: Patients with marginal bone loss (MBL); The MBL group consisted of 22 patients (14M /8F) aged between 27 and 67 years Group 3: Patients with healthy peri-implant tissues (HI); The HI group consisted of 22 patients(7M/15F) with ages ranging from 29 to 62 years Group 4: Healthy control (HC) 21 individuals (8M/ 13F) whose ages ranged between 27 and 67 years
Key inclusion criteria (8 listed)
- Adults aged 18 and older;
- Being systemically healthy; ,
- Being non-smokers;
- For dental implant groups, at least 1 osseointegrated implant;
- Dental implant applied by at least a specialist-level physician;
Key exclusion criteria (10 listed)
- Any history of medical conditions;
- Presence of active periodontal disease;
- Use of antibiotic or anti-inflammatory medications in the past 3 months;
- Pregnancy;
- Use of AO supplements;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identifying patients to be included in the study and collecting saliva samples
Time frame: 1 year
Patients to be included in the study were determined by clinical and radiological examinations, divided into groups, and saliva samples; it was collected to measure the total oxidant status (TOS) and advanced oxidation protein products (AOPP) to evaluate the oxidant concentration in it, and the total antioxidant status (TAS) to evaluate the antioxidant concentration in it and stored at -80 degrees Celsius.
1 secondary outcome
Biochemical examination of oxidant and antioxidant biomarkers in saliva and statistical evaluation of the results
Time frame: 4 month
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 13 Feb 2023.
- Background: PubMed 12787220Berglundh T, Persson L, Klinge B. A systematic review of the incidence of biological and technical complications in implant dentistry reported in prospective longitudinal studies of at least 5 years. J Clin Periodontol. 2002;29 Suppl 3:197-212; discussion 232-3. doi: 10.1034/j.1600-051x.29.s3.12.x.
- Background: PubMed 16038603Canakci CF, Cicek Y, Canakci V. Reactive oxygen species and human inflammatory periodontal diseases. Biochemistry (Mosc). 2005 Jun;70(6):619-28. doi: 10.1007/s10541-005-0161-9.
- Background: PubMed 16696085Chapple IL. Role of free radicals and antioxidants in the pathogenesis of the inflammatory periodontal diseases. Clin Mol Pathol. 1996 Oct;49(5):M247-55. doi: 10.1136/mp.49.5.m247. No abstract available.
- Background: PubMed 9178107Chapple IL. Reactive oxygen species and antioxidants in inflammatory diseases. J Clin Periodontol. 1997 May;24(5):287-96. doi: 10.1111/j.1600-051x.1997.tb00760.x.
- Background: PubMed 12456773Chapple IL, Brock G, Eftimiadi C, Matthews JB. Glutathione in gingival crevicular fluid and its relation to local antioxidant capacity in periodontal health and disease. Mol Pathol. 2002 Dec;55(6):367-73. doi: 10.1136/mp.55.6.367.
- Background: PubMed 17214737Chapple IL, Brock GR, Milward MR, Ling N, Matthews JB. Compromised GCF total antioxidant capacity in periodontitis: cause or effect? J Clin Periodontol. 2007 Feb;34(2):103-10. doi: 10.1111/j.1600-051X.2006.01029.x. Epub 2006 Dec 13.
- Background: PubMed 17214840Chapple IL, Matthews JB. The role of reactive oxygen and antioxidant species in periodontal tissue destruction. Periodontol 2000. 2007;43:160-232. doi: 10.1111/j.1600-0757.2006.00178.x. No abstract available.
- Background: PubMed 22093005Chapple IL, Milward MR, Ling-Mountford N, Weston P, Carter K, Askey K, Dallal GE, De Spirt S, Sies H, Patel D, Matthews JB. Adjunctive daily supplementation with encapsulated fruit, vegetable and berry juice powder concentrates and clinical periodontal outcomes: a double-blind RCT. J Clin Periodontol. 2012 Jan;39(1):62-72. doi: 10.1111/j.1600-051X.2011.01793.x. Epub 2011 Oct 17.
- Background: PubMed 22455351Chen AF, Chen DD, Daiber A, Faraci FM, Li H, Rembold CM, Laher I. Free radical biology of the cardiovascular system. Clin Sci (Lond). 2012 Jul;123(2):73-91. doi: 10.1042/CS20110562.
- Background: PubMed 1591115Edgar WM. Saliva: its secretion, composition and functions. Br Dent J. 1992 Apr 25;172(8):305-12. doi: 10.1038/sj.bdj.4807861.
- Background: PubMed 15003729Erel O. A novel automated direct measurement method for total antioxidant capacity using a new generation, more stable ABTS radical cation. Clin Biochem. 2004 Apr;37(4):277-85. doi: 10.1016/j.clinbiochem.2003.11.015.
- Background: PubMed 16214125Erel O. A new automated colorimetric method for measuring total oxidant status. Clin Biochem. 2005 Dec;38(12):1103-11. doi: 10.1016/j.clinbiochem.2005.08.008. Epub 2005 Oct 7.
- Individual participant dataSharing planned: Undecided. It will be available when needed.
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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.
ZEYNEP S PEKCETIN-BAYAV, ASST. PROF. study director
Biruni University
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis and Bone Loss in Jaw, run by Biruni University.
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 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Identifying patients to be included in the study and collecting saliva samples (time frame: 1 year). 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 NCT05724706, which also lists 28 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 13 Feb 2023.