PeriodontitisNCT04261491
Impact of SRP on Bone Resorption and Systemic Inflammatory Markers in Postmenopausal Women With Periodontitis
A study testing scaling and root planing in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites in India.
Trial summary
This study is designed to determine the effect of treating postmenopausal women and using non-surgical techniques on biomarkers of systemic inflammation (IL-6 ) and systemic bone resorption (C-terminal collagen cross-links, CTX). Read more about this study
- Who is it for?
- Ages 52 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Dec 2019to 30 Dec 2021
- 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 52 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females in natural menopause since at least 5 years
- Periodontitis with 20 or more natural teeth (excluding third molars). Periodontitis criteria
- Periodontal classification stage 2 or stage 3 (2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions)
- More than 30% of sites bleeding on probing. Exclusion Criteria
- Systemic disease known to effect BMD including rheumatoid arthritis, ankylosing spondylitis, and chronic obstructive pulmonary disease.
- Systemic disease known to affect the course of periodontal disease like diabetes mellitus or immunologic disorders
Show all 14Show fewer
- Treatment with the following drugs in the previous 3 months: steroids, immune suppressants, antibiotics, anti-inflammatory drugs, statins, anti-convulsants, thiazide diuretic agents, anti-coagulants, or any other host modulatory drugs
- Recent history or presence of acute or chronic infection.
- History of metabolic bone disease, thyroid and parathyroid disease, and gastrointestinal disorders
- Early onset of menopause
- Treatment for low BMD with systemic medication including calcium and vitamin D supplementation, bisphosphonates, and hormone replacement therapy
- History of hysterectomy
- Current or former smokers or use of smokeless tobacco in any form
- periodontal treatment within 1 year prior to inclusion into the study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Sanjay Tewari
Rohtak, Haryana, 124001
About this study
Official title: Impact of Scaling and Root Planing on Systemic Inflammation and Serum Bone Resorption Markers in Postmenopausal Women With Low Bone Mineral Density With Periodontitis.
This study is designed to determine the effect of treating postmenopausal women and using non-surgical techniques on biomarkers of systemic inflammation (IL-6 ) and systemic bone resorption (C-terminal collagen cross-links, CTX).
Read the detailed description
Periodontitis is an inflammatory disease of tooth supporting tissues that is characterized by progressive loss of bone and periodontal attachment and which ultimately leads to tooth loss if left untreated. It is a widespread condition which affects 30% of the adult population. The prevalence increases to greater than 47% among adults age 30 years or older, with those over 65 years old accounting for most cases Osteoporosis is a disease characterized by low bone mineral density(BMD) and deterioration of bone microarchitecture, which leads to increased risk of fragility fractures. It has been reported that one out of two Indian females above the age of 50 years and one out of five Indian men above the age of 65 years are at risk of osteoporosis. It is apparent that both periodontitis and osteoporosis are chronic conditions characterized by resorptive osseous changes with multiple shared risk factors including age, genetics, hormonal change, smoking , as well as calcium and vitamin D deficiency. It has been proposed that the two diseases could also have a mutual relation and this has led to a considerable number of studies investigating the same .Both osteoporosis and periodontitis are more prevalent among elderly population. The number of patients who suffer from both periodontitis and osteoporosis is expected to rise as the average lifespan increases.
Eighty percent of individuals with osteoporosis are women, largely due to the marked loss in bone density associated with the withdrawal of estrogen that accompanies loss of ovarian function at menopause. There is now strong evidence to suggest that systemic pro-inflammatory cytokines in response to estrogen withdrawal at menopause is responsible for increased osteoclastic activity.Systemic Inflammation results in an uncoupling between bone resorption and formation and favours excessive bone resorption resulting in decreased bone mineral density and increased fracture risk in postmenopausal women. Pro-inflammatory cytokines capable of stimulating osteoclastic bone resorption include IL-1, TNF-α, IL-6,IL-11, IL-15 and IL-17. It has been demonstrated that while periodontitis is a local infectious disease of tooth supporting structures, it is also associated with higher inflammatory mediators in the systemic circulation. The data suggest that an individual's overall bone metabolism might be associated with periodontal disease and be reflective of its progression.
Levels of bone turnover markers (BTM) reflect the activity and number of bone forming (osteoblasts) and bone-degrading (osteoclasts) cells, providing an estimate of bone resorption and bone formation. BTM can be measured non-invasively in either blood or urine at a fairly low cost. C-terminal collagen cross-links,CTX, is a bone resorption marker which consists of cross-linked telopeptides from collagen which are released during enzymatic degradation of bone matrix by the osteoclasts Scaling and root planing (SRP) is the most accepted treatment for managing chronic periodontitis and is proven to be effective at controlling local inflammation. Recent research has found evidence that levels of systemic inflammatory markers including IL-1, TNF-α, and IL-6 are also reduced after SRP. Therefore, treatment of periodontal disease results in reduced systemic inflammation but it is unknown if this translates to better outcomes for management of osteoporosis. It is hypothesized that if periodontitis has an influence on bone remodeling, then levels of BTM would also vary with decrease in systemic inflammation owing to resolution of periodontal inflammation following non-surgical periodontal treatment. The purpose of this study is to determine the effect of treating periodontal disease in patients with osteoporosis with scaling and root planing on biomarkers of systemic inflammation (IL-6) and systemic bone turnover (CTX). It is anticipated that the results of this study could be useful in formulating recommendations for interdisciplinary management of patients of concomitant periodontitis and osteoporosis.
MATERIALS AND METHODOLOGY
STUDY DESIGN SETTING: The present prospective interventional study will be conducted in department of Periodontology , Post Graduate institute Dental Sciences,Rohtak.
STUDY PERIOD: 14 months STUDY POPULATION : Patients will be recruited from out patient department of Periodontology.
METHODOLOGY The study will be conducted as follows .
METHOD OF RECRUITMENT:
Post-menopausal females diagnosed with stage 2 and stage 3 periodontitis will be recruited from the outpatient department of Periodontology. Only those patients who consent for the study will be included after obtaining an informed written consent. Those who fulfill the inclusion criteria will be enrolled in the study. Clinical periodontal parameters (CAL, PD and BOP) will be recorded and venous blood samples for measuring serum levels of IL-6 and sCTX will be collected. Scaling and root planing will be performed in all cases. All patients will be re-evaluated after 8 weeks for recording clinical periodontal parameters and serum inflammatory and bone resorption markers as before.
INTERVENTION Full mouth scaling and root planing (SRP) will be performed for all participants with both ultrasonic instruments and manual instrumentation using scalers and curettes. All patients will be given instructions for maintaining proper oral hygiene using soft toothbrush and fluoridated toothpaste. No mouthwashes will be prescribed.
FOLLOW UP OF STUDY PARTICIPANTS All participants will be evaluated for clinical periodontal parameters (PD, CAL and BOP) at 8 weeks after completion of SRP. Serum inflammatory (IL-6) and bone resorption markers (CTX) will be evaluated only for those participants in whom <10 % bleeding sites .
BODY MASS INDEX (BMI) BMI=Weight(kg)/Height²(m²)
BIOCHEMICAL PARAMETERS Venous blood from the anticubital vein will be collected after overnight fasting after applying a tourniquet in a plain vacutainer tube without additive. Immediately after collection of blood samples,the samples will be centrifuged, and separated serum and plasma will be stored at -80̊ c until processed. The level of following biomarkers will be evaluated using ELISA kits- IL-6,sCTX All the blood samples will be collected at the baseline and 8 weeks following SRP.
- Conditions
- Periodontitis
- Being tested
- scaling and root planing
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planingProcedure or surgery
scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal women with chronic periodontitis | Experimental | postmenopausal women with chronic periodontitis will be evaluated after SRP for serum bone resorption markers- CTX and inflammatory markers IL-6 Receives: Procedure: scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum IL-6,
change in serum IL-6,
Measured: 2 months
s-CTX
change in serum carboxy terminal collagen cross links
Measured: 2 months
Secondary outcomes (3)
Platelet count
change in platelet count
Measured: 2 months
platelet distribution width PDW
change in platelet distribution width PDW
Measured: 2 months
mean platalet volume
change in mean platelet volume
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Dec 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROMA RATHEE, Principal investigator, Post Graduate Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261491
- Sponsor's protocol ID
- roma rathee perio
- Status last verified
- Apr 2022
- First submitted
- 3 Feb 2020
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Scaling and Root Planing on Systemic Inflammation and Serum Bone Resorption Markers in Postmenopausal Women With Low Bone Mineral Density With Periodontitis.
- ClinicalTrials.gov ID
- NCT04261491
- Acronym / sponsor ID
- roma rathee perio
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 7 Feb 2020 (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.
This study is designed to determine the effect of treating postmenopausal women and using non-surgical techniques on biomarkers of systemic inflammation (IL-6 ) and systemic bone resorption (C-terminal collagen cross-links, CTX).
Detailed description
Periodontitis is an inflammatory disease of tooth supporting tissues that is characterized by progressive loss of bone and periodontal attachment and which ultimately leads to tooth loss if left untreated. It is a widespread condition which affects 30% of the adult population. The prevalence increases to greater than 47% among adults age 30 years or older, with those over 65 years old accounting for most cases Osteoporosis is a disease characterized by low bone mineral density(BMD) and deterioration of bone microarchitecture, which leads to increased risk of fragility fractures. It has been reported that one out of two Indian females above the age of 50 years and one out of five Indian men above the age of 65 years are at risk of osteoporosis. It is apparent that both periodontitis and osteoporosis are chronic conditions characterized by resorptive osseous changes with multiple shared risk factors including age, genetics, hormonal change, smoking , as well as calcium and vitamin D deficiency. It has been proposed that the two diseases could also have a mutual relation and this has led to a considerable number of studies investigating the same .Both osteoporosis and periodontitis are more prevalent among elderly population. The number of patients who suffer from both periodontitis and osteoporosis is expected to rise as the average lifespan increases.
Eighty percent of individuals with osteoporosis are women, largely due to the marked loss in bone density associated with the withdrawal of estrogen that accompanies loss of ovarian function at menopause. There is now strong evidence to suggest that systemic pro-inflammatory cytokines in response to estrogen withdrawal at menopause is responsible for increased osteoclastic activity.Systemic Inflammation results in an uncoupling between bone resorption and formation and favours excessive bone resorption resulting in decreased bone mineral density and increased fracture risk in postmenopausal women. Pro-inflammatory cytokines capable of stimulating osteoclastic bone resorption include IL-1, TNF-α, IL-6,IL-11, IL-15 and IL-17. It has been demonstrated that while periodontitis is a local infectious disease of tooth supporting structures, it is also associated with higher inflammatory mediators in the systemic circulation. The data suggest that an individual's overall bone metabolism might be associated with periodontal disease and be reflective of its progression.
Levels of bone turnover markers (BTM) reflect the activity and number of bone forming (osteoblasts) and bone-degrading (osteoclasts) cells, providing an estimate of bone resorption and bone formation. BTM can be measured non-invasively in either blood or urine at a fairly low cost. C-terminal collagen cross-links,CTX, is a bone resorption marker which consists of cross-linked telopeptides from collagen which are released during enzymatic degradation of bone matrix by the osteoclasts Scaling and root planing (SRP) is the most accepted treatment for managing chronic periodontitis and is proven to be effective at controlling local inflammation. Recent research has found evidence that levels of systemic inflammatory markers including IL-1, TNF-α, and IL-6 are also reduced after SRP. Therefore, treatment of periodontal disease results in reduced systemic inflammation but it is unknown if this translates to better outcomes for management of osteoporosis. It is hypothesized that if periodontitis has an influence on bone remodeling, then levels of BTM would also vary with decrease in systemic inflammation owing to resolution of periodontal inflammation following non-surgical periodontal treatment. The purpose of this study is to determine the effect of treating periodontal disease in patients with osteoporosis with scaling and root planing on biomarkers of systemic inflammation (IL-6) and systemic bone turnover (CTX). It is anticipated that the results of this study could be useful in formulating recommendations for interdisciplinary management of patients of concomitant periodontitis and osteoporosis.
MATERIALS AND METHODOLOGY
STUDY DESIGN SETTING: The present prospective interventional study will be conducted in department of Periodontology , Post Graduate institute Dental Sciences,Rohtak.
STUDY PERIOD: 14 months STUDY POPULATION : Patients will be recruited from out patient department of Periodontology.
METHODOLOGY The study will be conducted as follows .
METHOD OF RECRUITMENT:
Post-menopausal females diagnosed with stage 2 and stage 3 periodontitis will be recruited from the outpatient department of Periodontology. Only those patients who consent for the study will be included after obtaining an informed written consent. Those who fulfill the inclusion criteria will be enrolled in the study. Clinical periodontal parameters (CAL, PD and BOP) will be recorded and venous blood samples for measuring serum levels of IL-6 and sCTX will be collected. Scaling and root planing will be performed in all cases. All patients will be re-evaluated after 8 weeks for recording clinical periodontal parameters and serum inflammatory and bone resorption markers as before.
INTERVENTION Full mouth scaling and root planing (SRP) will be performed for all participants with both ultrasonic instruments and manual instrumentation using scalers and curettes. All patients will be given instructions for maintaining proper oral hygiene using soft toothbrush and fluoridated toothpaste. No mouthwashes will be prescribed.
FOLLOW UP OF STUDY PARTICIPANTS All participants will be evaluated for clinical periodontal parameters (PD, CAL and BOP) at 8 weeks after completion of SRP. Serum inflammatory (IL-6) and bone resorption markers (CTX) will be evaluated only for those participants in whom <10 % bleeding sites .
BODY MASS INDEX (BMI) BMI=Weight(kg)/Height²(m²)
BIOCHEMICAL PARAMETERS Venous blood from the anticubital vein will be collected after overnight fasting after applying a tourniquet in a plain vacutainer tube without additive. Immediately after collection of blood samples,the samples will be centrifuged, and separated serum and plasma will be stored at -80̊ c until processed. The level of following biomarkers will be evaluated using ELISA kits- IL-6,sCTX All the blood samples will be collected at the baseline and 8 weeks following SRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postmenopausal women with chronic periodontitis | Experimental | Procedure: scaling and root planingpostmenopausal women with chronic periodontitis will be evaluated after SRP for serum bone resorption markers- CTX and inflammatory markers IL-6 |
Who may qualify
- Ages
- 52 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Females in natural menopause since at least 5 years
- Periodontitis with 20 or more natural teeth (excluding third molars). Periodontitis criteria
- Periodontal classification stage 2 or stage 3 (2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions)
- More than 30% of sites bleeding on probing. Exclusion Criteria
- Systemic disease known to effect BMD including rheumatoid arthritis, ankylosing spondylitis, and chronic obstructive pulmonary disease.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| scaling and root planingscaling and root planing | Procedure or surgery | postmenopausal women with chronic periodontitis |
Primary outcome
serum IL-6,
Time frame: 2 months
change in serum IL-6,
s-CTX
Time frame: 2 months
change in serum carboxy terminal collagen cross links
3 secondary outcomes
Platelet count
Time frame: 2 months
platelet distribution width PDW
Time frame: 2 months
mean platalet volume
Time frame: 2 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 2 May 2022.
- Individual participant dataSharing planned: Yes. study protocol
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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.
ROMA RATHEE principal investigator
Post Graduate Institute of Dental Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scaling and root planing in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites in India.
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 14 inclusion and 0 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 2 May 2022. 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 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?
serum IL-6, (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2022.