Chronic PeriodontitisNCT02111005
Smoking Influence on Apoptosis in Periodontitis
An observational study of Chronic Periodontitis and Aggressive Periodontitis, run by Damascus University at 2 sites in Syria.
Trial summary
Apoptosis is an evolutionary form of physiological cell death. Studies suggest that apoptosis is involved in the pathogenesis of periodontal diseases. Human gingival fibroblasts (HGF) have an important role in the periodontal immune response. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Aggressive Periodontitis
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 2 sitesSyria
- Study dates
- Apr 2015to Mar 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 80 subjects will be invited to participate in this study from the patients referred to the Department of Periodontology, Faculty of Dentistry, University of Damascus. Patients should have a diagnosis of periodontitis (either chronic or aggressive). Any candidate will be approached and informed about this clinical study with the relevant information sheet. Informed consent forms will be obtained.Using five clinical parameters and full mouth or panoramic radiographs, the participants will be allocated to four groups according to their condition as well as their smoking habit. The description of these groups has given before.
Who may be able to join
- Patients of Syrian descent
- Systemically healthy
- Have at least 20 teeth
Who cannot join
- Periodontal treatment during the last three months
- History of major systemic diseases
- Consumption of antibiotics or anti-inflammatory drugs in the last three months
- Smoking
- Alcohol consumption
- Pregnant and lactating women.
Trial locations and contacts
2 sites in 1 country.
Syria2 sites
Department of Periodontics, University of Damascus Dental School
Damascus, Rif-dimashq Governorate, DM20AM18
Ali Abou Sulaiman
Damascus, Syrian Arab Republic, DM20AM18
About this study
Official title: Influence of Smoking on Fibroblast Apoptosis in Patients With Chronic and Aggressive Periodontitis
Apoptosis is an evolutionary form of physiological cell death. Studies suggest that apoptosis is involved in the pathogenesis of periodontal diseases. Human gingival fibroblasts (HGF) have an important role in the periodontal immune response. It is believed that HGF can be diminished and/or eliminated by means of apoptosis.
Smoking is one of the most common risk factor of periodontal disease. Studies indicated that smoking can increase the risk of periodontitis by enhancing the apoptosis of gingival fibroblast.
Read more
The purpose of this study is to determine and to investigate apoptosis of HGF in gingival biopsies collected from smokers and non smokers who are diagnosed with chronic periodontitis or aggressive periodontitis.
Eighty subjects will be invited to participate in this study. Patients will be allocated into four groups (20 patients each). Gingival biopsies will be obtained from the base of papillae during surgical treatment (open flap curettage) and will be examined by Immuno-histochemical analysis. Immune-staining will be done using p53 monoclonal mouse anti-human antibody.
Read the detailed description
Background:
The mechanisms responsible for gingival tissue damage are poorly understood, and both immune-mediated reactions and direct cytopathic effects of bacteria maybe involved. Based on direct effect of bacteria in cell cultures, it has been suggested that apoptosis might play an important role in periodontitis (Chen 1994).
Programmed cell death (apoptosis) is normal physiologic process that contributes to maintaining tissue homeostasis. The process of apoptosis can be modulated by various stimuli hormones, cytokines, growth factors, infections and immune-responses (Renehan et al. 2001).
Among other factors, the products of two genes that encode protein p53 and Bcl-2 have been shown to play fundamental regulatory role in apoptosis. P53 is the protein product of tumor-suppressor gene, and expression of P53 can induce apoptosis. This protein is also implicated in the regulation of tissue dynamics, and is specifically thought to induce apoptosis in terminally differentiated cells, including inflammatory cells (Bulut et al.2006).
Fibroblast is a type of cell that synthesizes the extracellular and collagen in connective tissue. It plays a critical role in wound healing. Fibroblasts are the most common cells in connective tissue. The main function of fibroblasts is to maintain the structural integrity of connective tissue by continuously secreting precursors of extracellular matrix. it was reported that apoptosis levels increased in gingivitis and periodontitis (Jarenberg et al. 2002).
Cigarette smoking is a risk factor for many diseases, and recent evidence indicates that smoking adversely influences periodontal health. A number of epidemiologic studies have shown strong association between smoking and prevalence and severity of periodontitis (Bostrom et al. 1998). Whereas, the pathogenesis of periodontitis in smokers is poorly understood there are data suggesting that smoking effects on the periodontal tissues include defects in neutrophil function, impaired serum antibody responses to periodontal pathogens, and potentially diminished gingival fibroblast function (Shivanaikar et al. 2001). Smokers are considered a high-risk group for periodontitis, and smoking history is a useful clinical predictor of future disease activity (Hanokia et al. 2000).
Aims of the study:
- Investigation of the effects of smoking on fibroblasts apoptosis in smokers with periodontitis compared to non-smokers with periodontitis using immuno-histochemical methods.
- Comparison of apoptosis levels of gingival fibroblasts between chronic and aggressive periodontitis.
Materials and methods:
A total of 80 subjects will be invited to participate in this study from the patients referred to the Department of Periodontology, Faculty of Dentistry, University of Damascus. The study will be approved by a specific Review Board. Subjects will be recruited according to specific inclusion criteria after completion of medical and dental history questionnaires. Patients will sign a consent form after being advised about the nature of the study.
The selection of patients will be made according of the criteria approved by the 1999 international world workshop for a classification system of periodontal diseases and conditions (Armitage 1999) using five clinical parameters and full mouth or panoramic radiographs for diagnosis.
Subjects will be allocated into four groups:
- Smoking Chronic Periodontitis group (ChP-S): comprise 20 patients who are smokers and aged > 45 years and have presence of ≥2 non-adjacent sites per quadrant that were not first molars or incisors, with probing depth (PD) ≥5 mm, which bleed on gentle probing. The demonstrated radiographic bone loss ≥30% of the root length, patient with poor oral hygiene, the amount of accumulated plaque commensurate with the amount of clinical attachment level (CAL)
- Non-smoking Chronic periodontitis group (ChP-NS): comprise 20 age-sex matched patients who are non-smokers and have chronic periodontitis.
- Smoking Aggressive Periodontitis group (AgP-S): comprise 20 patients who are smokers and aged < 35 years and diagnosed with rapid attachment loss with periodontal pocket depth (PD) > 4 mm around at least three teeth other than the first molars and incisors. Rapid bone destruction (>50%bone loss at diseased sites). Weak relationship between dental plaque and the severity of gingival inflammation.
- Non-smoking Aggressive periodontitis group (AgP-NS): comprise 20 age- and sex matched patients who are non-smokers and have aggressive periodontitis.
Clinical measurements:
A standard periodontal probe will be used for recording periodontal indices at six sites per tooth. The examined clinical parameters include bleeding on probing (BOP), plaque index (PI), clinical attachment loss (CAL) and periodontal pocket depth (PPD) and gingival index (GI).
Biopsy collection and analysis
- The biopsy samples will be obtained from patients during surgical treatment (open flap curettage) where biopsy is taken from the base area of papilla.
- Samples will be placed in 10% formalin.
- The samples will be then installed in paraffin wax.
- Samples will be analyzed in the by means of p53 monoclonal mouse anti-human antibody.
- Conditions
- Chronic Periodontitis, Aggressive Periodontitis
- Keywords
- apoptosis, periodontal disease, smoking
- Medical subject headings
- Chronic Periodontitis, Aggressive Periodontitis, Periodontal Diseases, Smoking
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 |
|---|---|---|
| Smoking Aggressive Periodontitis group | This group comprises 20 patients who are smokers and aged < 35 years and diagnosed with rapid attachment loss with periodontal pocket depth (PD) > 4 mm around at least three teeth other than the first molars and incisors. Rapid bone destruction (>50%bone loss at diseased sites). Weak relationship between dental plaque and the severity of gingival inflammation. | |
| Smoking Chronic Periodontitis group | This group comprises 20 patients who are smokers and aged > 45 years and have presence of ≥2 non-adjacent sites per quadrant that were not first molars or incisors, with probing depth (PD) ≥5 mm, which bleed on gentle probing. The demonstrated radiographic bone loss ≥30% of the root length, patient with poor oral hygiene, the amount of accumulated plaque commensurate with the amount of clinical attachment level (CAL) | |
| Non-smoking Aggressive Periodontitis grp | This group comprises 20 patients who are age- and sex- matched to the 'Smoking Aggressive Periodontitis group' and are non-smokers suffering from aggressive periodontitis. | |
| Non-smoking Chronic periodontitis grp | This group comprises 20 patients who are age- and sex-matched to the 'Smoking Chronic Periodontitis group' and are non-smokers suffering from chronic periodontitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
P53 levels in gingival biopsy samples
This variable is going to be measured by an immunohistochemical analysis
Measured: The measurement will be performed at T0 (baseline measurement) once the sample has been recruited
Secondary outcomes (1)
presence or absence of fibroblasts' apoptosis in the gingival tissues
this variable is going to be measured by an immunohistochemical analysis
Measured: The measurement will be performed at T0 (baseline measurement) once the sample has been recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Abou Sulaiman, DDS MSc PhD, Principal investigator, University of Damascus Dental School, Department of PeriodontologySharif Barakat, DDS MSc Phd, Study director, University of Damascus Dental School, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111005
- Sponsor's protocol ID
- UDDS-Perio-01-2014
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
PubMed 10863370Bostrom L, Linder LE, Bergstrom J. Clinical expression of TNF-alpha in smoking-associated periodontal disease. J Clin Periodontol. 1998 Oct;25(10):767-73. doi: 10.1111/j.1600-051x.1998.tb02368.x.
PubMed 9797047Bulut S, Uslu H, Ozdemir BH, Bulut OE. Expression of caspase-3, p53 and Bcl-2 in generalized aggressive periodontitis. Head Face Med. 2006 Jun 20;2:17. doi: 10.1186/1746-160X-2-17.
PubMed 16787530Chen Y, Zychlinsky A. Apoptosis induced by bacterial pathogens. Microb Pathog. 1994 Oct;17(4):203-12. doi: 10.1006/mpat.1994.1066.
PubMed 7715420Jarnbring F, Somogyi E, Dalton J, Gustafsson A, Klinge B. Quantitative assessment of apoptotic and proliferative gingival keratinocytes in oral and sulcular epithelium in patients with gingivitis and periodontitis. J Clin Periodontol. 2002 Dec;29(12):1065-71. doi: 10.1034/j.1600-051x.2002.291203.x.
PubMed 12492905Hanioka T, Tanaka M, Ojima M, Takaya K, Matsumori Y, Shizukuishi S. Oxygen sufficiency in the gingiva of smokers and non-smokers with periodontal disease. J Periodontol. 2000 Dec;71(12):1846-51. doi: 10.1902/jop.2000.71.12.1846.
PubMed 11156041Renehan AG, Booth C, Potten CS. What is apoptosis, and why is it important? BMJ. 2001 Jun 23;322(7301):1536-8. doi: 10.1136/bmj.322.7301.1536. No abstract available.
PubMed 11420279Shivanaikar S, Faizuddin M and Bhatt K. Influence of smoking on fibroblast apoptosis in chronic periodontitis. RGUHS J Dent Sciences. 2001; 3: 9-14
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Smoking on Fibroblast Apoptosis in Patients With Chronic and Aggressive Periodontitis
- ClinicalTrials.gov ID
- NCT02111005
- Acronym / sponsor ID
- UDDS-Perio-01-2014
- Conditions
- Chronic Periodontitis, Aggressive Periodontitis
- Keywords
- apoptosis, periodontal disease, smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Apr 2014 (estimated)
- 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.
Apoptosis is an evolutionary form of physiological cell death. Studies suggest that apoptosis is involved in the pathogenesis of periodontal diseases. Human gingival fibroblasts (HGF) have an important role in the periodontal immune response. It is believed that HGF can be diminished and/or eliminated by means of apoptosis.
Smoking is one of the most common risk factor of periodontal disease. Studies indicated that smoking can increase the risk of periodontitis by enhancing the apoptosis of gingival fibroblast.
The purpose of this study is to determine and to investigate apoptosis of HGF in gingival biopsies collected from smokers and non smokers who are diagnosed with chronic periodontitis or aggressive periodontitis.
Eighty subjects will be invited to participate in this study. Patients will be allocated into four groups (20 patients each). Gingival biopsies will be obtained from the base of papillae during surgical treatment (open flap curettage) and will be examined by Immuno-histochemical analysis. Immune-staining will be done using p53 monoclonal mouse anti-human antibody.
Detailed description
Background:
The mechanisms responsible for gingival tissue damage are poorly understood, and both immune-mediated reactions and direct cytopathic effects of bacteria maybe involved. Based on direct effect of bacteria in cell cultures, it has been suggested that apoptosis might play an important role in periodontitis (Chen 1994).
Programmed cell death (apoptosis) is normal physiologic process that contributes to maintaining tissue homeostasis. The process of apoptosis can be modulated by various stimuli hormones, cytokines, growth factors, infections and immune-responses (Renehan et al. 2001).
Among other factors, the products of two genes that encode protein p53 and Bcl-2 have been shown to play fundamental regulatory role in apoptosis. P53 is the protein product of tumor-suppressor gene, and expression of P53 can induce apoptosis. This protein is also implicated in the regulation of tissue dynamics, and is specifically thought to induce apoptosis in terminally differentiated cells, including inflammatory cells (Bulut et al.2006).
Fibroblast is a type of cell that synthesizes the extracellular and collagen in connective tissue. It plays a critical role in wound healing. Fibroblasts are the most common cells in connective tissue. The main function of fibroblasts is to maintain the structural integrity of connective tissue by continuously secreting precursors of extracellular matrix. it was reported that apoptosis levels increased in gingivitis and periodontitis (Jarenberg et al. 2002).
Cigarette smoking is a risk factor for many diseases, and recent evidence indicates that smoking adversely influences periodontal health. A number of epidemiologic studies have shown strong association between smoking and prevalence and severity of periodontitis (Bostrom et al. 1998). Whereas, the pathogenesis of periodontitis in smokers is poorly understood there are data suggesting that smoking effects on the periodontal tissues include defects in neutrophil function, impaired serum antibody responses to periodontal pathogens, and potentially diminished gingival fibroblast function (Shivanaikar et al. 2001). Smokers are considered a high-risk group for periodontitis, and smoking history is a useful clinical predictor of future disease activity (Hanokia et al. 2000).
Aims of the study:
- Investigation of the effects of smoking on fibroblasts apoptosis in smokers with periodontitis compared to non-smokers with periodontitis using immuno-histochemical methods.
- Comparison of apoptosis levels of gingival fibroblasts between chronic and aggressive periodontitis.
Materials and methods:
A total of 80 subjects will be invited to participate in this study from the patients referred to the Department of Periodontology, Faculty of Dentistry, University of Damascus. The study will be approved by a specific Review Board. Subjects will be recruited according to specific inclusion criteria after completion of medical and dental history questionnaires. Patients will sign a consent form after being advised about the nature of the study.
The selection of patients will be made according of the criteria approved by the 1999 international world workshop for a classification system of periodontal diseases and conditions (Armitage 1999) using five clinical parameters and full mouth or panoramic radiographs for diagnosis.
Subjects will be allocated into four groups:
- Smoking Chronic Periodontitis group (ChP-S): comprise 20 patients who are smokers and aged > 45 years and have presence of ≥2 non-adjacent sites per quadrant that were not first molars or incisors, with probing depth (PD) ≥5 mm, which bleed on gentle probing. The demonstrated radiographic bone loss ≥30% of the root length, patient with poor oral hygiene, the amount of accumulated plaque commensurate with the amount of clinical attachment level (CAL)
- Non-smoking Chronic periodontitis group (ChP-NS): comprise 20 age-sex matched patients who are non-smokers and have chronic periodontitis.
- Smoking Aggressive Periodontitis group (AgP-S): comprise 20 patients who are smokers and aged < 35 years and diagnosed with rapid attachment loss with periodontal pocket depth (PD) > 4 mm around at least three teeth other than the first molars and incisors. Rapid bone destruction (>50%bone loss at diseased sites). Weak relationship between dental plaque and the severity of gingival inflammation.
- Non-smoking Aggressive periodontitis group (AgP-NS): comprise 20 age- and sex matched patients who are non-smokers and have aggressive periodontitis.
Clinical measurements:
A standard periodontal probe will be used for recording periodontal indices at six sites per tooth. The examined clinical parameters include bleeding on probing (BOP), plaque index (PI), clinical attachment loss (CAL) and periodontal pocket depth (PPD) and gingival index (GI).
Biopsy collection and analysis
- The biopsy samples will be obtained from patients during surgical treatment (open flap curettage) where biopsy is taken from the base area of papilla.
- Samples will be placed in 10% formalin.
- The samples will be then installed in paraffin wax.
- Samples will be analyzed in the by means of p53 monoclonal mouse anti-human antibody.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Smoking Aggressive Periodontitis group | – | –This group comprises 20 patients who are smokers and aged < 35 years and diagnosed with rapid attachment loss with periodontal pocket depth (PD) > 4 mm around at least three teeth other than the first molars and incisors. Rapid bone destruction (>50%bone loss at diseased sites). Weak relationship between dental plaque and the severity of gingival inflammation. |
| Smoking Chronic Periodontitis group | – | –This group comprises 20 patients who are smokers and aged > 45 years and have presence of ≥2 non-adjacent sites per quadrant that were not first molars or incisors, with probing depth (PD) ≥5 mm, which bleed on gentle probing. The demonstrated radiographic bone loss ≥30% of the root length, patient with poor oral hygiene, the amount of accumulated plaque commensurate with the amount of clinical attachment level (CAL) |
| Non-smoking Aggressive Periodontitis grp | – | –This group comprises 20 patients who are age- and sex- matched to the 'Smoking Aggressive Periodontitis group' and are non-smokers suffering from aggressive periodontitis. |
| Non-smoking Chronic periodontitis grp | – | –This group comprises 20 patients who are age- and sex-matched to the 'Smoking Chronic Periodontitis group' and are non-smokers suffering from chronic periodontitis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 80 subjects will be invited to participate in this study from the patients referred to the Department of Periodontology, Faculty of Dentistry, University of Damascus. Patients should have a diagnosis of periodontitis (either chronic or aggressive). Any candidate will be approached and informed about this clinical study with the relevant information sheet. Informed consent forms will be obtained.Using five clinical parameters and full mouth or panoramic radiographs, the participants will be allocated to four groups according to their condition as well as their smoking habit. The description of these groups has given before.
Key inclusion criteria (3 listed)
- Patients of Syrian descent
- Systemically healthy
- Have at least 20 teeth
Key exclusion criteria (6 listed)
- Periodontal treatment during the last three months
- History of major systemic diseases
- Consumption of antibiotics or anti-inflammatory drugs in the last three months
- Smoking
- Alcohol consumption
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
P53 levels in gingival biopsy samples
Time frame: The measurement will be performed at T0 (baseline measurement) once the sample has been recruited
This variable is going to be measured by an immunohistochemical analysis
1 secondary outcome
presence or absence of fibroblasts' apoptosis in the gingival tissues
Time frame: The measurement will be performed at T0 (baseline measurement) once the sample has been recruited
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 16 Mar 2016.
- Background: PubMed 10863370Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
- Background: PubMed 9797047Bostrom L, Linder LE, Bergstrom J. Clinical expression of TNF-alpha in smoking-associated periodontal disease. J Clin Periodontol. 1998 Oct;25(10):767-73. doi: 10.1111/j.1600-051x.1998.tb02368.x.
- Background: PubMed 16787530Bulut S, Uslu H, Ozdemir BH, Bulut OE. Expression of caspase-3, p53 and Bcl-2 in generalized aggressive periodontitis. Head Face Med. 2006 Jun 20;2:17. doi: 10.1186/1746-160X-2-17.
- Background: PubMed 7715420Chen Y, Zychlinsky A. Apoptosis induced by bacterial pathogens. Microb Pathog. 1994 Oct;17(4):203-12. doi: 10.1006/mpat.1994.1066.
- Background: PubMed 12492905Jarnbring F, Somogyi E, Dalton J, Gustafsson A, Klinge B. Quantitative assessment of apoptotic and proliferative gingival keratinocytes in oral and sulcular epithelium in patients with gingivitis and periodontitis. J Clin Periodontol. 2002 Dec;29(12):1065-71. doi: 10.1034/j.1600-051x.2002.291203.x.
- Background: PubMed 11156041Hanioka T, Tanaka M, Ojima M, Takaya K, Matsumori Y, Shizukuishi S. Oxygen sufficiency in the gingiva of smokers and non-smokers with periodontal disease. J Periodontol. 2000 Dec;71(12):1846-51. doi: 10.1902/jop.2000.71.12.1846.
- Background: PubMed 11420279Renehan AG, Booth C, Potten CS. What is apoptosis, and why is it important? BMJ. 2001 Jun 23;322(7301):1536-8. doi: 10.1136/bmj.322.7301.1536. No abstract available.
- BackgroundShivanaikar S, Faizuddin M and Bhatt K. Influence of smoking on fibroblast apoptosis in chronic periodontitis. RGUHS J Dent Sciences. 2001; 3: 9-14
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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.
Ali Abou Sulaiman, DDS MSc PhD principal investigator
University of Damascus Dental School, Department of Periodontology
Sharif Barakat, DDS MSc Phd study director
University of Damascus Dental School, Department of Periodontology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis and Aggressive Periodontitis, run by Damascus University at 2 sites in Syria.
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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Syria. 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?
P53 levels in gingival biopsy samples (time frame: The measurement will be performed at T0 (baseline measurement) once the sample has been recruited). 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 NCT02111005, which also lists 8 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 16 Mar 2016.