PeriodontitisNCT04259242
SRP, Systemic Inflammation and Serum Bone Resorption Markers Premenopausal Women With Periodontitis and Low BMD
A study testing SRP in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
To assess the impact of scaling and root planing on systemic inflammation and serum bone resorption markers in pre-menopausal women with periodontitis Read more about this study
- Who is it for?
- Ages 40 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- SRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2020to 31 Jan 2022
- 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 40 to 46 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-menopausal women ( Pre-menopause was defined as women above 40 years of age with regular menstruation).
- Periodontitis with 20 or more natural teeth (excluding third molars). Periodontitis criteria
- Periodontal classification stage 2 and stage 3 ( 2017 World Workshop on classification of Periodontal and peri-implant Disease and conditions)
- Bleeding on probing with more than 30% site ( 2017 World Workshop on classification of Periodontal and peri-implant Disease and conditions)
Who cannot join
- Systemic inflammatory diseases known to affect BMD such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, and chronic obstructive pulmonary disease.
- History of diabetes, metabolic bone disease, thyroid and parathyroid disease, and gastrointestinal disorders
- Treatment with the following drugs in the previous 3 months : steroids, immunosuppressants, antibiotics, NSAIDs ,statins, lipid lowering drugs, anticonvulsants, thiazide diuretic agents, anti-coagulants, oral contraceptive drugs or any other host modulatory drug
- Recent history or presence of acute or chronic infection
- Previous history of treatment for osteoporosis/osteopenia.
- Current or former smokers or use of smokeless tobacco in any form
- Periodontal treatment within past 1 year prior to inclusion into the study.
- pregnant and lactating mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Scaling and Root Planing on Systemic Inflammation and Serum Bone Resorption Markers in Premenopausal Women With Periodontitis and Low Bone Mineral Density- A Prospective Interventional Study.
To assess the impact of scaling and root planing on systemic inflammation and serum bone resorption markers in pre-menopausal women with periodontitis
Read the detailed description
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic plaque biofilms and characterized by progressive destruction of the tooth supporting apparatus. Its primary features include the loss of periodontal tissue support, manifested through clinical attachment loss (CAL) and radiographically assessed alveolar bone loss, presence of periodontal pocketing and gingival bleeding.
Periodontitis is multifactorial inflammatory disease with numerous systemic or local risk factors playing a part in its clinical sequences. Periodontitis causes increased local inflammation as well as contributes to systemic inflammation with an increase in the levels of local and systemic inflammatory mediators including tumor necrosis factor alpha (TNF-α), interleukin-1 and interleukin-6 (IL-6).
Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase bone fragility and susceptibility to fracture.
The development of osteoporosis occurs through spontaneous increase in pro-inflammatory and pro-osteoclastic cytokines such as , IL-6 and IL-1 β that activates receptor activator of nuclear factor-Kb ligand (RANKL) leading to an enhanced ability of osteoclasts to resorb bone.
The Studies on systemic influence of periodontitis have suggested that locally produced proinflammatory cytokines such as IL-1β , TNF-α and IL-6 may be released into circulation. Most studies shows that IL-6 and TNF-α is major cytokine responsible for resorption of bone in osteoporosis and increase of bone turnover markers. Periodontitis is chronic inflammatory disease characterized by destruction of tooth supporting tissues by virtue of the immunologic response to bacterial challenge originating from dental plaque. In Periodontitis, the increased released of proinflammatory cytokines such as TNF- α, IL-1β, and IL-6 in systemic circulation which causes increase in systemic bone loss through their osteoclastic activity. The systemic inflammation and rate of bone loss is measured by systemic inflammatory and bone resorption markers respectively.
Till date there is no conclusive interventional study done on impact of management of periodontitis on systemic inflammation and bone resorption markers(serum CTX) in pre-menopausal women with periodontitis .
METHODOLOGY The study will be conducted as follows This prospective interventional study will be conducted in the department of Periodontics and Oral Implantology, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak.
Periodontitis patients will be recruited from the outpatient department of PGIDS, Rohtak.
Sample Size calculation:
Sample size was calculated using G power software using t test to compare difference between two matched (dependent) means . Total sample size was calculated as 19. A total of 24 patients will be recruited expecting a 25% dropout rate.
Periodontal parameters:
At baseline, periodontal parameters plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment loss (CAL) will be assessed at six sites (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual) per tooth excluding third molars. Periodontal examination would be performed at baseline and 8 weeks after scaling and root planing.
Periodontal therapy:
After recording periodontal parameters at baseline, oral hygiene instructions would be given and scaling and root planning would be done. Patient would be recalled at after 8 weeks of complete scaling and root planing.
Blood collection and serum analysis:
For assessing markers of systemic inflammation and bone resorption, serum samples will be collected from venipuncture in antecubital fossa at 8 hours and after an overnight fasting for all subjects at baseline in individuals meeting the inclusion criteria. Serum samples would again be analyzed for systemic markers at 8 weeks after scaling and root planing in individuals who have bleeding on probing (BOP) less than 10% of the total sites.
Parameters of systemic inflammation that would be assessed:
Interleukin-6 (IL-6) Total leukocyte count(TLC) Differential leukocyte count (DLC) Platelet count Neutrophil/lymphocyte ratio (N/L) mean platelet volume platelet distribution width
Systemic marker of bone resorption that would be analyzed:
Serum C-terminal telopeptide of type 1 collagen (s-CTX-1)
Anthropometric parameter that would be measured:
Body Mass Index (BMI) calculated as weight/height 2 (Kg/m2)
METHOD:
Pre-menopausal women having stage 2 or stage 3 periodontitis would be enrolled to participate in the study. Those who fulfill the inclusion criteria would be enrolled in the study clinical periodontal parameters(CAL,PD,and BOP) would be recorded and venous blood samples for measuring serum levels of IL-6, and serum CTX-1 would be collected. Scaling and root planing would be performed in all cases.
Patients would be re-evaluated after 8 weeks for recording all the periodontal parameters and systemic inflammation (IL-6 ) and systemic resorption marker (serum CTX-1 ).
- Conditions
- Periodontitis
- Being tested
- SRP
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRPProcedure or surgery
scaling and root planing with ultrasonic scaler and manual instruments
| Study group | Role | What they receive |
|---|---|---|
| premenopausal women with periodontitis | Experimental | Experimental: premenopausal women with periodontitis premenopausal women with chronic periodontitis will be evaluated after SRP for serum bone resorption markers - CTX and inflammatory markers IL-6 Receives: Procedure: SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum IL-6 .
change in serum IL-6
Measured: 8 weeks
serum CTX-1
Change in serum CTX-1
Measured: 8 WEEKS
Secondary outcomes (3)
Platelet count
Number of platelets
Measured: 8 weeks
PMV
Platelet Mean Volume
Measured: 8 weeks
PDV
Platelet Distribution Width
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jan 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pradeep Sharma, Principal investigator, Post Graduate Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259242
- Sponsor's protocol ID
- Pradeep perio
- Status last verified
- May 2022
- First submitted
- 2 Feb 2020
- Last updated
- 10 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 10 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 Premenopausal Women With Periodontitis and Low Bone Mineral Density- A Prospective Interventional Study.
- ClinicalTrials.gov ID
- NCT04259242
- Acronym / sponsor ID
- Pradeep perio
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 6 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.
To assess the impact of scaling and root planing on systemic inflammation and serum bone resorption markers in pre-menopausal women with periodontitis
Detailed description
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic plaque biofilms and characterized by progressive destruction of the tooth supporting apparatus. Its primary features include the loss of periodontal tissue support, manifested through clinical attachment loss (CAL) and radiographically assessed alveolar bone loss, presence of periodontal pocketing and gingival bleeding.
Periodontitis is multifactorial inflammatory disease with numerous systemic or local risk factors playing a part in its clinical sequences. Periodontitis causes increased local inflammation as well as contributes to systemic inflammation with an increase in the levels of local and systemic inflammatory mediators including tumor necrosis factor alpha (TNF-α), interleukin-1 and interleukin-6 (IL-6).
Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase bone fragility and susceptibility to fracture.
The development of osteoporosis occurs through spontaneous increase in pro-inflammatory and pro-osteoclastic cytokines such as , IL-6 and IL-1 β that activates receptor activator of nuclear factor-Kb ligand (RANKL) leading to an enhanced ability of osteoclasts to resorb bone.
The Studies on systemic influence of periodontitis have suggested that locally produced proinflammatory cytokines such as IL-1β , TNF-α and IL-6 may be released into circulation. Most studies shows that IL-6 and TNF-α is major cytokine responsible for resorption of bone in osteoporosis and increase of bone turnover markers. Periodontitis is chronic inflammatory disease characterized by destruction of tooth supporting tissues by virtue of the immunologic response to bacterial challenge originating from dental plaque. In Periodontitis, the increased released of proinflammatory cytokines such as TNF- α, IL-1β, and IL-6 in systemic circulation which causes increase in systemic bone loss through their osteoclastic activity. The systemic inflammation and rate of bone loss is measured by systemic inflammatory and bone resorption markers respectively.
Till date there is no conclusive interventional study done on impact of management of periodontitis on systemic inflammation and bone resorption markers(serum CTX) in pre-menopausal women with periodontitis .
METHODOLOGY The study will be conducted as follows This prospective interventional study will be conducted in the department of Periodontics and Oral Implantology, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak.
Periodontitis patients will be recruited from the outpatient department of PGIDS, Rohtak.
Sample Size calculation:
Sample size was calculated using G power software using t test to compare difference between two matched (dependent) means . Total sample size was calculated as 19. A total of 24 patients will be recruited expecting a 25% dropout rate.
Periodontal parameters:
At baseline, periodontal parameters plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment loss (CAL) will be assessed at six sites (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual) per tooth excluding third molars. Periodontal examination would be performed at baseline and 8 weeks after scaling and root planing.
Periodontal therapy:
After recording periodontal parameters at baseline, oral hygiene instructions would be given and scaling and root planning would be done. Patient would be recalled at after 8 weeks of complete scaling and root planing.
Blood collection and serum analysis:
For assessing markers of systemic inflammation and bone resorption, serum samples will be collected from venipuncture in antecubital fossa at 8 hours and after an overnight fasting for all subjects at baseline in individuals meeting the inclusion criteria. Serum samples would again be analyzed for systemic markers at 8 weeks after scaling and root planing in individuals who have bleeding on probing (BOP) less than 10% of the total sites.
Parameters of systemic inflammation that would be assessed:
Interleukin-6 (IL-6) Total leukocyte count(TLC) Differential leukocyte count (DLC) Platelet count Neutrophil/lymphocyte ratio (N/L) mean platelet volume platelet distribution width
Systemic marker of bone resorption that would be analyzed:
Serum C-terminal telopeptide of type 1 collagen (s-CTX-1)
Anthropometric parameter that would be measured:
Body Mass Index (BMI) calculated as weight/height 2 (Kg/m2)
METHOD:
Pre-menopausal women having stage 2 or stage 3 periodontitis would be enrolled to participate in the study. Those who fulfill the inclusion criteria would be enrolled in the study clinical periodontal parameters(CAL,PD,and BOP) would be recorded and venous blood samples for measuring serum levels of IL-6, and serum CTX-1 would be collected. Scaling and root planing would be performed in all cases.
Patients would be re-evaluated after 8 weeks for recording all the periodontal parameters and systemic inflammation (IL-6 ) and systemic resorption marker (serum CTX-1 ).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premenopausal women with periodontitis | Experimental | Procedure: SRPExperimental: premenopausal women with periodontitis premenopausal women with chronic periodontitis will be evaluated after SRP for serum bone resorption markers - CTX and inflammatory markers IL-6 |
Who may qualify
- Ages
- 40 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pre-menopausal women ( Pre-menopause was defined as women above 40 years of age with regular menstruation).
- Periodontitis with 20 or more natural teeth (excluding third molars). Periodontitis criteria
- Periodontal classification stage 2 and stage 3 ( 2017 World Workshop on classification of Periodontal and peri-implant Disease and conditions)
- Bleeding on probing with more than 30% site ( 2017 World Workshop on classification of Periodontal and peri-implant Disease and conditions)
Key exclusion criteria (8 listed)
- Systemic inflammatory diseases known to affect BMD such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, and chronic obstructive pulmonary disease.
- History of diabetes, metabolic bone disease, thyroid and parathyroid disease, and gastrointestinal disorders
- Treatment with the following drugs in the previous 3 months : steroids, immunosuppressants, antibiotics, NSAIDs ,statins, lipid lowering drugs, anticonvulsants, thiazide diuretic agents, anti-coagulants, oral contraceptive drugs or any other host modulatory drug
- Recent history or presence of acute or chronic infection
- Previous history of treatment for osteoporosis/osteopenia.
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 |
|---|---|---|
| SRPscaling and root planing with ultrasonic scaler and manual instruments | Procedure or surgery | premenopausal women with periodontitis |
Primary outcome
Change in serum IL-6 .
Time frame: 8 weeks
change in serum IL-6
serum CTX-1
Time frame: 8 WEEKS
Change in serum CTX-1
3 secondary outcomes
Platelet count
Time frame: 8 weeks
PMV
Time frame: 8 weeks
PDV
Time frame: 8 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 10 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.
Pradeep Sharma principal investigator
Post Graduate Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRP in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak 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?
The sponsor lists 4 inclusion and 8 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 10 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 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?
Change in serum IL-6 . (time frame: 8 weeks). 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 10 May 2022.