Molar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis)NCT04984031
Apoptosis Markers in Aggressive Periodontitis
An observational study of Molar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) and Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis), run by Asem Mohammed Kamel Ali at 1 site in Egypt.
Trial summary
The aim of the present trial is to assess the gingival crevicular fluid level of caspase-3 and apoptosis inducing factor (AIF) in Generalized versus Molar-incisor grade C periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Molar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis), Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)
- What is being tested?
- ELISA assessment of apoptosis markers in gingival crevicular fluid
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2021to 1 Mar 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The present study will carry out on fifty patients ranged in age from (18 - 75) years diagnosed as having aggressive periodontitis. All patients were selected from those attending at outpatient dental clinic of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology Department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Clinical and radiographic examination will be performed by two calibrated periodontists to confirm accurate diagnosis.
Who may be able to join
- Patients must be free from any systemic diseases according to criteria of Modified Cornell Medical Index.
- Males and females aged ≥18 years old.
- All subjects should be cooperative.
Who cannot join
- females, who were lactating or pregnant, will be excluded.
- smoker's or former smokers also will be excluded .
- any other periodontal diseases, except generalized grade c periodontitis or molar-incisor grade c periodontitis
- Patients received antibiotics or non- steroidal anti-inflammatory drugs 3 months or periodontal treatment 6 months' before the beginning of the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dental medicine Al-Azhar University (Assiut branch)
Asyut, Asyut Governorate, 71511
About this study
Official title: Assessment of Apoptosis Markers Caspase-3, Caspase-8, Caspase-9 and Apoptosis Inducing Factor (AIF) Levels in Generalized Versus Molar-incisor Grade C Periodontitis
The aim of the present trial is to assess the gingival crevicular fluid level of caspase-3 and apoptosis inducing factor (AIF) in Generalized versus Molar-incisor grade C periodontitis.
The present study will be carried out on patients selected from those attending on the outpatient clinics of Department of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology, Faculty of Dental Medicine, Al-Azhar University, Assiut.
Read the detailed description
Periodontal diseases are inflammatory disorders that give rise to tissue damage and loss, as a result of complex interactions between pathogenic bacteria and host immune response. Gingivitis is generally regarded as a site-specific inflammatory condition initiated by dental biofilm accumulation and characterized by gingival redness and edema and the absence of periodontal attachment loss.(1,2) periodontitis, a disease characterized by gingival inflammation combined with connective tissue attachment and bone loss.
Aggressive periodontitis is a form of periodontal disease characterized by rapid attachment loss, bone destruction, non-contributory medical history and family history of the cases Apoptosis is a fundamental and complex biological process that enables an organism to kill and remove unwanted cells during development, normal homeostasis and disease.
Caspases are proteins implicated in the activation and execution of apoptosis was identified in humans as being crucial for this process. Caspases 3 appear to be activated in a protease cascade that leads to inappropriate activation or rapid disablement of key structural proteins and important signaling, homeostatic and repair enzymes and is essential for some of the characteristic changes in cell morphology and certain biochemical events associated with the execution and completion of apoptosis. However, the specific requirements of this caspase in apoptosis were until now largely unknown. Apoptosis-inducing factor (AIF) is a mitochondrion-localized flavoprotein with nicotinamide dinucleotide (NADH) oxidase activity is encoded by a nuclear gene. It has been shown to translocate from mitochondria to the cytosol as well as the nucleus when apoptosis is induced and mediate caspase-independent death because inhibition of caspase activation.
Many authors view apoptosis as a process that is near-to-synonymous to massive caspase activation. The existence of a caspase-independent death effector thus does not fit the dominant scheme. During the last 2 years, several papers advocated the hypothesis that AIF is indeed a caspase-dependent death effector, meaning that the translocation of AIF from the mitochondrion (where it would be inert) to the nucleus (where it would induce apoptosis) would be caspase-dependent.
- Conditions
- Molar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis), Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)
- Being tested
- ELISA assessment of apoptosis markers in gingival crevicular fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA assessment of apoptosis markers in gingival crevicular fluidDiagnostic test
Gingival crevicular fluid (GCF) samples will be collected to assess the level of caspase-3,8,9 and apoptosis inducing factor (Aif)
| Study group | Role | What they receive |
|---|---|---|
| Generalized grade C periodontitis | generalized aggressive periodontitis ( generalized Grade C ,as in new classification) patients characterized with Bone loss/age index more than 1 and extent more 30 % Receives: Diagnostic Test: ELISA assessment of apoptosis markers in gingival crevicular fluid | |
| Molar-incisor grade C periodontitis | localized aggressive periodontitis ( Molar-incisor pattern Grade C ,as in new classification) patients characterized with limited affection on molars and incisors and their Bone loss/age index more than 1. Receives: Diagnostic Test: ELISA assessment of apoptosis markers in gingival crevicular fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
caspase 3 , picograms/millimeter (pg/ml) in gingival crevicular fluid
GCF from the mesio-buccal site of each tooth was collected using paper strips held in place for 30 seconds, and then removed. GCF volume (ml) was measured using a calibrated machine. After volume determination, strips were stored in sterile collection tubes that were labeled and then stored at - 80C. Enzyme-linked immunosorbent assays were used to quantify caspase 3 amount in picograms and its concentration (pg/ml) estimated according to the following formula= total caspase 3 amount (pg) / volume GCF (ml).
Measured: through diagnosis completion, an average of 6 months
caspase 8 , picograms/millimeter (pg/ml) in gingival crevicular fluid
GCF from the mesio-buccal site of each tooth was collected using paper strips held in place for 30 seconds, and then removed. GCF volume (ml) was measured using a calibrated machine. After volume determination, strips were stored in sterile collection tubes that were labeled and then stored at - 80C. Enzyme-linked immunosorbent assays were used to quantify caspase 8 amount in picograms and its concentration (pg/ml) estimated according to the following formula= total caspase 8 amount (pg) / volume GCF (ml).
Measured: through diagnosis completion, an average of 6 months
caspase 9 , picograms/millimeter (pg/ml) in gingival crevicular fluid
GCF from the mesio-buccal site of each tooth was collected using paper strips held in place for 30 seconds, and then removed. GCF volume (ml) was measured using a calibrated machine. After volume determination, strips were stored in sterile collection tubes that were labeled and then stored at - 80C. Enzyme-linked immunosorbent assays were used to quantify caspase 9 amount in picograms and its concentration (pg/ml) estimated according to the following formula= total caspase 9 amount (pg) / volume GCF (ml).
Measured: through diagnosis completion, an average of 6 months
Apoptosis Inducing Factor(AIF), picograms/millimeter (pg/ml) in gingival crevicular fluid
GCF from the mesio-buccal site of each tooth was collected using paper strips held in place for 30 seconds, and then removed. GCF volume (ml) was measured using a calibrated machine. After volume determination, strips were stored in sterile collection tubes that were labeled and then stored at - 80C. Enzyme-linked immunosorbent assays were used to quantify AIF amount in picograms and its concentration (pg/ml) estimated according to the following formula= total AIF amount (pg) / volume GCF (ml).
Measured: through diagnosis completion, an average of 6 months
Secondary outcomes (5)
Gingival Index
gingival index used to measure gingival inflammation. The degree of gingival inflammation was assessed as follow: 0 = Normal gingiva.
- Mild inflammation, slight change in color, slight edema and no bleeding on probing.
- Moderate inflammation, redness, edema and bleeding on probing.
- Sever inflammation, marked redness, edema and tendency to spontaneous bleeding.
Measured: through diagnosis completion, an average of 6 months
Plaque Index
Plaque index measured to assess plaque accumulation around gingival margin. The degree of plaque accumulation was assessed as follows:
0 = no plaque around the gingival margin.
- = A thin film of plaque around the gingival margin. The plaque may be recognized only by running a probe across the tooth surface.
- = moderate accumulation of soft deposits on the gingival margin and/or adjacent tooth surface, which can be seen by naked eye.
- = Abundance plaque accumulation within the gingival pocket and/or on the gingival margin and adjacent tooth surface and hard deposits on the tooth surface are seen.
Measured: through diagnosis completion, an average of 6 months
Attachment level
Attachment level by mm was measured using color -coded probe. The distance from the cemento-enamal junction to the free gingival margin and the distance from the free gingival margin to the base of the pocket where properly measured. The difference between the two measurements yields the attachment level in millimeter (mm).
Measured: baseline, immediately after complete diagnosis and before any intervention or therapy
Bleeding on probing (BOP)
Bleeding on probing (BOP) at a force of 0.3N.with a manual pressure of sensitive probe, recorded on distal, facial, mesial, gingival surfaces.
Calculation = (Number of bleeding surfaces / total number of tooth surface) *100.Expressed in percentage (%) of gingival units bleeding on probing FMBS.
In the rating system, 0 indicates absence of bleeding on probing, with 15%, 20% and >20% indicating an increased percentage of inflammation/infection.
Measured: through diagnosis completion, an average of 6 months
radiographic evaluation at molar-incisor area
Marginal bone loss around all central incisors and first molars was evaluated using periapical radiographs. The distance from cemento-enamel junction to the crest of alveolar bone will represent bone lost by mm
Measured: through diagnosis completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start5 Aug 2021
- Primary completion30 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Molar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asem Mohammed Kamel Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asem Mohammed Kamel Ali, Al-Azhar University
- Investigators
- Mohammed F Edress, associate professor, Study director, Faculty of dental medicine Al-Azhar university Assiut BranchAhmed M Hussein, phD, Principal investigator, Oral and Maxillofacial Pathology Department, Faculty of dentistry, Assiut UniversityAhmed H Gaber, phD, Principal investigator, Department of oral pathology Faculty of dental medicine Al-Azhar University (Assiut branch)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984031
- Sponsor's protocol ID
- Apoptosis in periodontitis
- Status last verified
- Sep 2024
- First submitted
- 29 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gamonal J, Bascones A, Acevedo A, Blanco E, Silva A. Apoptosis in chronic adult periodontitis analyzed by in situ DNA breaks, electron microscopy, and immunohistochemistry. J Periodontol. 2001 Apr;72(4):517-25. doi: 10.1902/jop.2001.72.4.517.
PubMed 11338305Dabiri D, Halubai S, Layher M, Klausner C, Makhoul H, Lin GH, Eckert G, Abuhussein H, Kamarajan P, Kapila Y. The Role of Apoptotic Factors in Assessing Progression of Periodontal Disease. Int J Dent Oral Sci. 2016 Sep;3(9):318-325. doi: 10.19070/2377-8075-1600064. Epub 2016 Sep 3.
PubMed 28540365Armitage GC, Cullinan MP. Comparison of the clinical features of chronic and aggressive periodontitis. Periodontol 2000. 2010 Jun;53:12-27. doi: 10.1111/j.1600-0757.2010.00353.x.
PubMed 20403102Nicholson DW, Thornberry NA. Caspases: killer proteases. Trends Biochem Sci. 1997 Aug;22(8):299-306. doi: 10.1016/s0968-0004(97)01085-2.
PubMed 9270303
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Apoptosis Markers Caspase-3, Caspase-8, Caspase-9 and Apoptosis Inducing Factor (AIF) Levels in Generalized Versus Molar-incisor Grade C Periodontitis
- ClinicalTrials.gov ID
- NCT04984031
- Acronym / sponsor ID
- Apoptosis in periodontitis
- Conditions
- Molar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis), Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asem Mohammed Kamel AliUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 30 Jul 2021 (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 aim of the present trial is to assess the gingival crevicular fluid level of caspase-3 and apoptosis inducing factor (AIF) in Generalized versus Molar-incisor grade C periodontitis.
The present study will be carried out on patients selected from those attending on the outpatient clinics of Department of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology, Faculty of Dental Medicine, Al-Azhar University, Assiut.
Detailed description
Periodontal diseases are inflammatory disorders that give rise to tissue damage and loss, as a result of complex interactions between pathogenic bacteria and host immune response. Gingivitis is generally regarded as a site-specific inflammatory condition initiated by dental biofilm accumulation and characterized by gingival redness and edema and the absence of periodontal attachment loss.(1,2) periodontitis, a disease characterized by gingival inflammation combined with connective tissue attachment and bone loss.
Aggressive periodontitis is a form of periodontal disease characterized by rapid attachment loss, bone destruction, non-contributory medical history and family history of the cases Apoptosis is a fundamental and complex biological process that enables an organism to kill and remove unwanted cells during development, normal homeostasis and disease.
Caspases are proteins implicated in the activation and execution of apoptosis was identified in humans as being crucial for this process. Caspases 3 appear to be activated in a protease cascade that leads to inappropriate activation or rapid disablement of key structural proteins and important signaling, homeostatic and repair enzymes and is essential for some of the characteristic changes in cell morphology and certain biochemical events associated with the execution and completion of apoptosis. However, the specific requirements of this caspase in apoptosis were until now largely unknown. Apoptosis-inducing factor (AIF) is a mitochondrion-localized flavoprotein with nicotinamide dinucleotide (NADH) oxidase activity is encoded by a nuclear gene. It has been shown to translocate from mitochondria to the cytosol as well as the nucleus when apoptosis is induced and mediate caspase-independent death because inhibition of caspase activation.
Many authors view apoptosis as a process that is near-to-synonymous to massive caspase activation. The existence of a caspase-independent death effector thus does not fit the dominant scheme. During the last 2 years, several papers advocated the hypothesis that AIF is indeed a caspase-dependent death effector, meaning that the translocation of AIF from the mitochondrion (where it would be inert) to the nucleus (where it would induce apoptosis) would be caspase-dependent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generalized grade C periodontitis | – | Diagnostic Test: ELISA assessment of apoptosis markers in gingival crevicular fluidgeneralized aggressive periodontitis ( generalized Grade C ,as in new classification) patients characterized with Bone loss/age index more than 1 and extent more 30 % |
| Molar-incisor grade C periodontitis | – | Diagnostic Test: ELISA assessment of apoptosis markers in gingival crevicular fluidlocalized aggressive periodontitis ( Molar-incisor pattern Grade C ,as in new classification) patients characterized with limited affection on molars and incisors and their Bone loss/age index more than 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The present study will carry out on fifty patients ranged in age from (18 - 75) years diagnosed as having aggressive periodontitis. All patients were selected from those attending at outpatient dental clinic of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology Department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Clinical and radiographic examination will be performed by two calibrated periodontists to confirm accurate diagnosis.
Key inclusion criteria (3 listed)
- Patients must be free from any systemic diseases according to criteria of Modified Cornell Medical Index.
- Males and females aged ≥18 years old.
- All subjects should be cooperative.
Key exclusion criteria (4 listed)
- females, who were lactating or pregnant, will be excluded.
- smoker's or former smokers also will be excluded .
- any other periodontal diseases, except generalized grade c periodontitis or molar-incisor grade c periodontitis
- Patients received antibiotics or non- steroidal anti-inflammatory drugs 3 months or periodontal treatment 6 months' before the beginning of the study
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 |
|---|---|---|
| ELISA assessment of apoptosis markers in gingival crevicular fluidGingival crevicular fluid (GCF) samples will be collected to assess the level of caspase-3,8,9 and apoptosis inducing factor (Aif) | Diagnostic test | Generalized grade C periodontitis, Molar-incisor grade C periodontitis |
Primary outcome
caspase 3 , picograms/millimeter (pg/ml) in gingival crevicular fluid
Time frame: through diagnosis completion, an average of 6 months
GCF from the mesio-buccal site of each tooth was collected using paper strips held in place for 30 seconds, and then removed. GCF volume (ml) was measured using a calibrated machine. After volume determination, strips were stored in sterile collection tubes that were labeled and then stored at - 80C. Enzyme-linked immunosorbent assays were used to quantify caspase 3 amount in picograms and its concentration (pg/ml) estimated according to the following formula= total caspase 3 amount (pg) / volume GCF (ml).
caspase 8 , picograms/millimeter (pg/ml) in gingival crevicular fluid
Time frame: through diagnosis completion, an average of 6 months
GCF from the mesio-buccal site of each tooth was collected using paper strips held in place for 30 seconds, and then removed. GCF volume (ml) was measured using a calibrated machine. After volume determination, strips were stored in sterile collection tubes that were labeled and then stored at - 80C. Enzyme-linked immunosorbent assays were used to quantify caspase 8 amount in picograms and its concentration (pg/ml) estimated according to the following formula= total caspase 8 amount (pg) / volume GCF (ml).
caspase 9 , picograms/millimeter (pg/ml) in gingival crevicular fluid
Time frame: through diagnosis completion, an average of 6 months
GCF from the mesio-buccal site of each tooth was collected using paper strips held in place for 30 seconds, and then removed. GCF volume (ml) was measured using a calibrated machine. After volume determination, strips were stored in sterile collection tubes that were labeled and then stored at - 80C. Enzyme-linked immunosorbent assays were used to quantify caspase 9 amount in picograms and its concentration (pg/ml) estimated according to the following formula= total caspase 9 amount (pg) / volume GCF (ml).
Apoptosis Inducing Factor(AIF), picograms/millimeter (pg/ml) in gingival crevicular fluid
Time frame: through diagnosis completion, an average of 6 months
GCF from the mesio-buccal site of each tooth was collected using paper strips held in place for 30 seconds, and then removed. GCF volume (ml) was measured using a calibrated machine. After volume determination, strips were stored in sterile collection tubes that were labeled and then stored at - 80C. Enzyme-linked immunosorbent assays were used to quantify AIF amount in picograms and its concentration (pg/ml) estimated according to the following formula= total AIF amount (pg) / volume GCF (ml).
5 secondary outcomes
Gingival Index
Time frame: through diagnosis completion, an average of 6 months
Plaque Index
Time frame: through diagnosis completion, an average of 6 months
Attachment level
Time frame: baseline, immediately after complete diagnosis and before any intervention or therapy
Bleeding on probing (BOP)
Time frame: through diagnosis completion, an average of 6 months
radiographic evaluation at molar-incisor area
Time frame: through diagnosis completion, an average of 6 months
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 19 Sep 2024.
- Background: PubMed 11338305Gamonal J, Bascones A, Acevedo A, Blanco E, Silva A. Apoptosis in chronic adult periodontitis analyzed by in situ DNA breaks, electron microscopy, and immunohistochemistry. J Periodontol. 2001 Apr;72(4):517-25. doi: 10.1902/jop.2001.72.4.517.
- Background: PubMed 28540365Dabiri D, Halubai S, Layher M, Klausner C, Makhoul H, Lin GH, Eckert G, Abuhussein H, Kamarajan P, Kapila Y. The Role of Apoptotic Factors in Assessing Progression of Periodontal Disease. Int J Dent Oral Sci. 2016 Sep;3(9):318-325. doi: 10.19070/2377-8075-1600064. Epub 2016 Sep 3.
- Background: PubMed 20403102Armitage GC, Cullinan MP. Comparison of the clinical features of chronic and aggressive periodontitis. Periodontol 2000. 2010 Jun;53:12-27. doi: 10.1111/j.1600-0757.2010.00353.x.
- Background: PubMed 9270303Nicholson DW, Thornberry NA. Caspases: killer proteases. Trends Biochem Sci. 1997 Aug;22(8):299-306. doi: 10.1016/s0968-0004(97)01085-2.
- Individual participant dataSharing planned: Undecided
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.
Mohammed F Edress, associate professor study director
Faculty of dental medicine Al-Azhar university Assiut Branch
Ahmed M Hussein, phD principal investigator
Oral and Maxillofacial Pathology Department, Faculty of dentistry, Assiut University
Ahmed H Gaber, phD principal investigator
Department of oral pathology Faculty of dental medicine Al-Azhar University (Assiut branch)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Molar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) and Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis), run by Asem Mohammed Kamel Ali at 1 site in Egypt.
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 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
caspase 3 , picograms/millimeter (pg/ml) in gingival crevicular fluid (time frame: through diagnosis completion, an average of 6 months). The study lists 4 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 NCT04984031, which also lists 4 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 19 Sep 2024.