PeriodontitisitsmcpNCT03639636
is the Sclerostin Marker of Chronic Periodontitis
A study testing non surgical and surgical periodontal therapy in people with Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
Reviewed literature suggests that sclerostin will inhibit the bone formation and ultimately leads to chronic periodontitis. Estimation of Sclerostin levels in the serum of periodontitis patients before and after intervention could explore the effectiveness of therapy and also give a more detailed insight into its… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- non surgical and surgical periodontal therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2017to 15 May 2018
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria:• Systemically healthy individuals with more than 50% remaining natural teeth
- All the patients who are diagnosed as having generalized chronic periodontitis based on the American Academy of Periodontology (AAP) classification.
- Probing Pocket Depth (PPD)/ Clinical Attachment Loss(CAL) ≥ 5mm
- Patients indicated for periodontal surgery
Exclusion Criteria:• The patients who have aggressive periodontitis/localized periodontitis
- Patients having any other systemic diseases
- Patients taking high-dose steroid therapy, radiation or immunosuppressive therapy and any other drug history.
- Pregnant and lactating woman.
- History of smoking within the past five years.
- Patients who had undergone periodontal therapy in the last six months.
- Intellectual disability
Trial locations and contacts
1 site in 1 country.
India1 site
Panineeya Institute of Dentalsciences and Research Center
Hyderabad, Telangana, 500060
About this study
Official title: Comparative Evaluation of Serum Sclerostin in Chronic Periodontitis Patients Before and After Surgical Periodontal Therapy in Conjunction With Nonsurgical Periodontal Therapy
Reviewed literature suggests that sclerostin will inhibit the bone formation and ultimately leads to chronic periodontitis. Estimation of Sclerostin levels in the serum of periodontitis patients before and after intervention could explore the effectiveness of therapy and also give a more detailed insight into its diagnostic and prognostic potential as a biomarker of periodontal disease.
Read the detailed description
Advances during the last decade provided relevant information on the regulation of Sost/sclerostin and its mechanism(s) of action. Several stimuli have been reported to regulate Sost/Sclerostin expression, however how these factors interplay to regulate the expression of this gene in a spatiotemporal manner is unknown. Animal studies demonstrate that sclerostin is key for skeletal homeostasis, and required for the bone anabolic response to mechanical loading although appears dispensable for PTH-induced bone gain. The knowledge provided by preclinical investigations resulted in clinical trials based on the neutralization of sclerostin activity as a novel osteoanabolic therapeutic approach. It is now clear that sclerostin is capable of uncoupling bone formation and bone resorption, by inhibiting osteoblast function while stimulating osteoclast function, as the bone gain achieved by pharmacologic inhibition of sclerostin results from stimulation of osteoblast activity and inhibition of bone resorption. Furthermore, the recent observations show that activation of βcatenin in osteocytes increases bone resorption and Rankl production in a sclerostin-dependent manner. Anti-sclerostin therapy has shown beneficial skeletal outcomes in osteoporotic patients, however more recent evidence shows that the anabolic effects of this therapy attenuate with time and that after discontinuation BMD returns to pretreatment levels over time. The new evidence showing increased levels of Sost/sclerostin (and Dkk1) after activation of Wnt-βcatenin signaling suggest that sclerostin (and Dkk1) act as a negative feedback limiting bone formation stimulated by this pathway.
In this study is there any alterations in sclerostin levels in serum response to periodontal therapy was checked. Periodontal therapy alters the inflammation pathway is a proven fact.
- Conditions
- Periodontitis
- Being tested
- non surgical and surgical periodontal therapy
- Keywords
- periodontitis, sclerostin, periodontal surgery, scaling and root planing
- Medical subject headings
- Periodontitis, Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non surgical and surgical periodontal therapyOther
scaling and root planing periodontal flap surgery
| Study group | Role | What they receive |
|---|---|---|
| interventional prospective study | Other | nonsurgical periodontal therapy(scaling and root planing) surgical therapy( flap surgery) Receives: Other: non surgical and surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
sclerostin level response to only scaling and root planing
measuring serum sclerostin levels in pg/ml(Pico grams per milli liter),
Measured: 4 weeks
Secondary outcomes (1)
sclerostin level response to periodontal surgery
measuring serum sclerostin levels after surgery in pg/ml(Pico grams per milli liter)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Jun 2017
- Primary completion20 Dec 2017
- Study completion15 May 2018
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Intervention model
- Sequential
- Model description
- interventional prospective study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banda Madhavi, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Jammula surya prasanna, mds, Study director, panineeya institute of dental sciences and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639636
- Sponsor's protocol ID
- madhavisclerostin
- Acronym
- itsmcp
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu M, Kurimoto P, Zhang J, Niu QT, Stolina M, Dechow PC, Feng JQ, Hesterman J, Silva MD, Ominsky MS, Richards WG, Ke H, Kostenuik PJ. Sclerostin and DKK1 Inhibition Preserves and Augments Alveolar Bone Volume and Architecture in Rats with Alveolar Bone Loss. J Dent Res. 2018 Aug;97(9):1031-1038. doi: 10.1177/0022034518766874. Epub 2018 Apr 4.
PubMed 29617179Chen H, Xu X, Liu M, Zhang W, Ke HZ, Qin A, Tang T, Lu E. Sclerostin antibody treatment causes greater alveolar crest height and bone mass in an ovariectomized rat model of localized periodontitis. Bone. 2015 Jul;76:141-8. doi: 10.1016/j.bone.2015.04.002. Epub 2015 Apr 11.
PubMed 25868799Taut AD, Jin Q, Chung JH, Galindo-Moreno P, Yi ES, Sugai JV, Ke HZ, Liu M, Giannobile WV. Sclerostin antibody stimulates bone regeneration after experimental periodontitis. J Bone Miner Res. 2013 Nov;28(11):2347-56. doi: 10.1002/jbmr.1984.
PubMed 23712325Balli U, Aydogdu A, Dede FO, Turer CC, Guven B. Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin, and Receptor Activator of Nuclear Factor-kappaB Ligand in Periodontitis. J Periodontol. 2015 Dec;86(12):1396-404. doi: 10.1902/jop.2015.150270. Epub 2015 Sep 14.
PubMed 26367496
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Serum Sclerostin in Chronic Periodontitis Patients Before and After Surgical Periodontal Therapy in Conjunction With Nonsurgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT03639636
- Acronym / sponsor ID
- itsmcp / madhavisclerostin
- Conditions
- Periodontitis
- Keywords
- periodontitis, sclerostin, periodontal surgery, scaling and root planing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 21 Aug 2018 (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.
Reviewed literature suggests that sclerostin will inhibit the bone formation and ultimately leads to chronic periodontitis. Estimation of Sclerostin levels in the serum of periodontitis patients before and after intervention could explore the effectiveness of therapy and also give a more detailed insight into its diagnostic and prognostic potential as a biomarker of periodontal disease.
Detailed description
Advances during the last decade provided relevant information on the regulation of Sost/sclerostin and its mechanism(s) of action. Several stimuli have been reported to regulate Sost/Sclerostin expression, however how these factors interplay to regulate the expression of this gene in a spatiotemporal manner is unknown. Animal studies demonstrate that sclerostin is key for skeletal homeostasis, and required for the bone anabolic response to mechanical loading although appears dispensable for PTH-induced bone gain. The knowledge provided by preclinical investigations resulted in clinical trials based on the neutralization of sclerostin activity as a novel osteoanabolic therapeutic approach. It is now clear that sclerostin is capable of uncoupling bone formation and bone resorption, by inhibiting osteoblast function while stimulating osteoclast function, as the bone gain achieved by pharmacologic inhibition of sclerostin results from stimulation of osteoblast activity and inhibition of bone resorption. Furthermore, the recent observations show that activation of βcatenin in osteocytes increases bone resorption and Rankl production in a sclerostin-dependent manner. Anti-sclerostin therapy has shown beneficial skeletal outcomes in osteoporotic patients, however more recent evidence shows that the anabolic effects of this therapy attenuate with time and that after discontinuation BMD returns to pretreatment levels over time. The new evidence showing increased levels of Sost/sclerostin (and Dkk1) after activation of Wnt-βcatenin signaling suggest that sclerostin (and Dkk1) act as a negative feedback limiting bone formation stimulated by this pathway.
In this study is there any alterations in sclerostin levels in serum response to periodontal therapy was checked. Periodontal therapy alters the inflammation pathway is a proven fact.
Study design
- Primary purpose
- Screening
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional prospective study
| Arm | Type | Receives |
|---|---|---|
| interventional prospective study | Other | Other: non surgical and surgical periodontal therapynonsurgical periodontal therapy(scaling and root planing) surgical therapy( flap surgery) |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| non surgical and surgical periodontal therapyscaling and root planing periodontal flap surgery | Other | interventional prospective study |
Primary outcome
sclerostin level response to only scaling and root planing
Time frame: 4 weeks
measuring serum sclerostin levels in pg/ml(Pico grams per milli liter),
1 secondary outcome
sclerostin level response to periodontal surgery
Time frame: 6 weeks
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 21 Aug 2018.
- Background: PubMed 29617179Liu M, Kurimoto P, Zhang J, Niu QT, Stolina M, Dechow PC, Feng JQ, Hesterman J, Silva MD, Ominsky MS, Richards WG, Ke H, Kostenuik PJ. Sclerostin and DKK1 Inhibition Preserves and Augments Alveolar Bone Volume and Architecture in Rats with Alveolar Bone Loss. J Dent Res. 2018 Aug;97(9):1031-1038. doi: 10.1177/0022034518766874. Epub 2018 Apr 4.
- Background: PubMed 25868799Chen H, Xu X, Liu M, Zhang W, Ke HZ, Qin A, Tang T, Lu E. Sclerostin antibody treatment causes greater alveolar crest height and bone mass in an ovariectomized rat model of localized periodontitis. Bone. 2015 Jul;76:141-8. doi: 10.1016/j.bone.2015.04.002. Epub 2015 Apr 11.
- Results publication: PubMed 23712325Taut AD, Jin Q, Chung JH, Galindo-Moreno P, Yi ES, Sugai JV, Ke HZ, Liu M, Giannobile WV. Sclerostin antibody stimulates bone regeneration after experimental periodontitis. J Bone Miner Res. 2013 Nov;28(11):2347-56. doi: 10.1002/jbmr.1984.
- Results publication: PubMed 26367496Balli U, Aydogdu A, Dede FO, Turer CC, Guven B. Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin, and Receptor Activator of Nuclear Factor-kappaB Ligand in Periodontitis. J Periodontol. 2015 Dec;86(12):1396-404. doi: 10.1902/jop.2015.150270. Epub 2015 Sep 14.
- 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.
Jammula surya prasanna, mds study director
panineeya institute of dental sciences and research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non surgical and surgical periodontal therapy in people with Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Aug 2018. 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 India. 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?
sclerostin level response to only scaling and root planing (time frame: 4 weeks). 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 NCT03639636, 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 21 Aug 2018.