Periodontal DiseaseNCT03227367
Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.
A study testing other : PRF in people with Periodontal Disease and Periodontal Bone Loss, run by Meenakshi Ammal Dental College and Hospital.
Trial summary
The present study is an effort to investigate the hypothesis that Platelet Rich Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation and in bone loss. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Periodontal Bone Loss, Osteoclastic Bone Loss
- What is being tested?
- other : PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2014to 18 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with age group between 30 to 45 years.
- Non-smokers.
- No previous history of periodontal treatment.
- Subjects with age group between 30 to 45 years.
- Presence of atleast 20 teeth
- More than 30% of the sites with clinical attachment loss.
- Non-smokers.
- No previous history of periodontal treatment.
Who cannot join
- Individuals with systemic disease
- Subjects under antibiotics or anti-inflammatory drugs within the previous 3 months.
- Pregnant and lactating women.
- Allergic to antibiotics.
About this study
Official title: Platelet Rich Fibrin/Biphasic Calcium Phosphate Impairs Osteoclasts Differentiation and Promotes Apoptosis by the Intrinsic Mitochondrial Pathway in Chronic Periodontitis
The present study is an effort to investigate the hypothesis that Platelet Rich Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation and in bone loss.
Read the detailed description
Study design
Fifty-five individuals from a suburban population were recruited. Out of them, 5 individuals refused to participate in the study. Finally, 50 participants were selected and divided into two groups, control group [Healthy individuals]: 25 Males/Females, aged 25 to 35 years and test group [Chronic periodontitis patients]: 25 Males/Females aged 30 to 45 years.
Demographic variables and periodontal parameters were measured in both the groups.The investigators explored the effect of Platelet rich fibrin (PRF)/Biphasic calcium phosphate (BCP) on differentiation and survival of osteoclasts obtained from peripheral blood of Chronic Periodontitis patients.
- Being tested
- other : PRF
- Keywords
- biomaterials, apoptosis, bone regeneration
- Medical subject headings
- Periodontal Diseases, Alveolar Bone Loss, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
other : PRFOther
Also called others : BCP, others : PRF/BCP combination
mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Mononuclear cells isolated from the peripheral blood of 25 chronic periodontitis patients were interveened with 1ml/well preparation of Platelet rich fibrin(PRF), Biphasic calcium phosphate (BCP) and PRF and BCP combination in-vitro. Receives: Other: other : PRF |
| control group | Other | Mononuclear cells isolated from the peripheral blood of healthy individuals in-vitro. Receives: Other: other : PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing pocket depth
probing pocket dept was measured using Williams periodontal probe at base line
Measured: base line
Secondary outcomes (2)
Protein expression on osteoclast cells was estimated with BCP, PRF alone and BCP/PRF combination.
Protein expression on cells was analyzed using Western blot in all the groups
Measured: 24 hours from baseline
The activity of caspase-3 in OCs.
The activity of caspase-3 was seen in OCs in all the groups
Measured: 24 hours from base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start17 Mar 2014
- Primary completion13 Apr 2016
- Study completion18 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: (Healthy individuals) comprised of 25 participants with clinically healthy periodontium. Test group: (Chronic periodontitis patients) comprised of 25 participants with signs of clinical inflammation and bone loss.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meenakshi Ammal Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
- Investigators
- shila samuel, MS, PhD, Principal investigator, VRR diagnostic institute chennaijaideep mahendra, MDS,PhD, Principal investigator, meenakshi ammal dental college chennai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227367
- Sponsor's protocol ID
- MU-107-IEC/2014
- Status last verified
- Jul 2017
- First submitted
- 25 Jun 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu CL, Lee SS, Tsai CH, Lu KH, Zhao JH, Chang YC. Platelet-rich fibrin increases cell attachment, proliferation and collagen-related protein expression of human osteoblasts. Aust Dent J. 2012 Jun;57(2):207-12. doi: 10.1111/j.1834-7819.2012.01686.x.
PubMed 22624763Colucci S, Mori G, Brunetti G, Coricciati M, Pignataro P, Oranger A, Cirulli N, Mastrangelo F, Grassi FR, Grano M. Interleukin-7 production by B lymphocytes affects the T cell-dependent osteoclast formation in an in vitro model derived from human periodontitis patients. Int J Immunopathol Pharmacol. 2005 Jul-Sep;18(3 Suppl):13-9.
PubMed 16848983
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Fibrin/Biphasic Calcium Phosphate Impairs Osteoclasts Differentiation and Promotes Apoptosis by the Intrinsic Mitochondrial Pathway in Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03227367
- Acronym / sponsor ID
- MU-107-IEC/2014
- Keywords
- biomaterials, apoptosis, bone regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 13 Apr 2016 (actual)
- Study completion
- 18 Mar 2017 (actual)
- First posted
- 24 Jul 2017 (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 present study is an effort to investigate the hypothesis that Platelet Rich Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation and in bone loss.
Detailed description
Study design
Fifty-five individuals from a suburban population were recruited. Out of them, 5 individuals refused to participate in the study. Finally, 50 participants were selected and divided into two groups, control group [Healthy individuals]: 25 Males/Females, aged 25 to 35 years and test group [Chronic periodontitis patients]: 25 Males/Females aged 30 to 45 years.
Demographic variables and periodontal parameters were measured in both the groups.The investigators explored the effect of Platelet rich fibrin (PRF)/Biphasic calcium phosphate (BCP) on differentiation and survival of osteoclasts obtained from peripheral blood of Chronic Periodontitis patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group: (Healthy individuals) comprised of 25 participants with clinically healthy periodontium. Test group: (Chronic periodontitis patients) comprised of 25 participants with signs of clinical inflammation and bone loss.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: other : PRFMononuclear cells isolated from the peripheral blood of 25 chronic periodontitis patients were interveened with 1ml/well preparation of Platelet rich fibrin(PRF), Biphasic calcium phosphate (BCP) and PRF and BCP combination in-vitro. |
| control group | Other | Other: other : PRFMononuclear cells isolated from the peripheral blood of healthy individuals in-vitro. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects with age group between 30 to 45 years.
- Non-smokers.
- No previous history of periodontal treatment.
- Subjects with age group between 30 to 45 years.
- Presence of atleast 20 teeth
Key exclusion criteria (4 listed)
- Individuals with systemic disease
- Subjects under antibiotics or anti-inflammatory drugs within the previous 3 months.
- Pregnant and lactating women.
- Allergic to antibiotics.
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 |
|---|---|---|
| other : PRFAlso: others : BCP, others : PRF/BCP combinationmononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination | Other | Test group, control group |
Primary outcome
probing pocket depth
Time frame: base line
probing pocket dept was measured using Williams periodontal probe at base line
2 secondary outcomes
Protein expression on osteoclast cells was estimated with BCP, PRF alone and BCP/PRF combination.
Time frame: 24 hours from baseline
The activity of caspase-3 in OCs.
Time frame: 24 hours from base line
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 26 Jul 2017.
- Results publication: PubMed 22624763Wu CL, Lee SS, Tsai CH, Lu KH, Zhao JH, Chang YC. Platelet-rich fibrin increases cell attachment, proliferation and collagen-related protein expression of human osteoblasts. Aust Dent J. 2012 Jun;57(2):207-12. doi: 10.1111/j.1834-7819.2012.01686.x.
- Results publication: PubMed 16848983Colucci S, Mori G, Brunetti G, Coricciati M, Pignataro P, Oranger A, Cirulli N, Mastrangelo F, Grassi FR, Grano M. Interleukin-7 production by B lymphocytes affects the T cell-dependent osteoclast formation in an in vitro model derived from human periodontitis patients. Int J Immunopathol Pharmacol. 2005 Jul-Sep;18(3 Suppl):13-9.
- Individual participant dataSharing planned: No
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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.
shila samuel, MS, PhD principal investigator
VRR diagnostic institute chennai
jaideep mahendra, MDS,PhD principal investigator
meenakshi ammal dental college chennai
Questions about this trial
What is this clinical trial studying?
A study testing other : PRF in people with Periodontal Disease and Periodontal Bone Loss, run by Meenakshi Ammal Dental College and Hospital.
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 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 26 Jul 2017. 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?
probing pocket depth (time frame: base line). 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 NCT03227367, which also lists 2 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 26 Jul 2017.