Allostatic LoadNCT06978712
Impact of Periodontal Inflammation on Allostatic Load
A study testing Sub-gingival instrumentation in people with Allostatic Load and Periodontitis, Chronic, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Periodontitis is a prevalent global health issue that contributes to systemic inflammation and is closely linked to stress as a risk factor. Both conditions have been investigated for bidirectional relationship. However, the results are inconsistent, and the mechanistic links remain unclear. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Allostatic Load, Periodontitis, Chronic
- What is being tested?
- Sub-gingival instrumentation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteIndia
- Study dates
- 10 Jun 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients with age group 30-50 years diagnosed with generalized periodontitis.
- Presence of minimum 20 teeth excluding third molars.
Who cannot join
- Periodontal treatment within last 6 months
- History of antibiotic use within the previous 3 months
- History of use of steroid, immunosuppressive and psychiatric drugs
- Pregnant and lactating women
- History of substance abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Rajinder K Sharma, MDS, +919416358222, rksharmamds@yahoo.in
Sanjay Tewari, MDS, 01262-297876, principal.pgids@uhsr.ac.in
About this study
Official title: Impact of Subgingival Instrumentation on Allostatic Load in Periodontitis
Periodontitis is a prevalent global health issue that contributes to systemic inflammation and is closely linked to stress as a risk factor. Both conditions have been investigated for bidirectional relationship. However, the results are inconsistent, and the mechanistic links remain unclear. Allostatic load, which measures the cumulative biological effects of stress, may be relevant in elucidating this connection. Inconsistent results have been reported in previous studies exploring the association between periodontitis and individual biomarkers of allostatic load. Furthermore, none of these studies has taken into consideration staging and grading of periodontitis. Additionally, while periodontal treatment has been shown to reduce both local and systemic inflammation, its effect on allostatic load remains unexplored till date. This study aims to fill these gaps by evaluating the relationship between these parameters of periodontitis and allostatic load. Evaluation of impact of subgingival instrumentation on allostatic load may further provide insights into the broader systemic benefits of periodontal interventions.
Read the detailed description
Stress is a significant risk factor for various chronic diseases, such as cardiovascular conditions, diabetes, and obesity, all of which have severe implications for public health. The relationship between stress and these chronic conditions is complex, involving both direct physiological changes and behavioural adaptations that affect health outcomes. While acute stress responses can be adaptive, chronic stress can lead to dysregulation of the body's homeostatic processes which results in allostatic load, refers to the cumulative physiological toll that the body experiences over time due to repeated or prolonged stress. Allostatic load disrupts the normal functioning of various bodily systems, including the cardiovascular, metabolic, and immune systems, which can lead to long-term health consequences such as hypertension, diabetes, and autoimmune diseases. dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic nervous system (SNS) during chronic stress is associated with elevated biomarkers such as cortisol, epinephrine, and dehydroepiandrosterone sulfate (DHEA-S). These biomarkers, along with other indicators like blood pressure, cholesterol, glycated haemoglobin (HbA1c), and C-reactive protein (CRP), serve as proxies for allostatic load and are critical in understanding the body's response to stress over time. Beyond its systemic effects, stress also plays a pivotal role in oral health. Chronic stress is known to increase inflammation, impair immune responses, and alter hormone levels, all of which contribute to the development and progression of oral diseases, including periodontal disease and dental caries. Stress-induced allostatic load is thought to play a role in the onset and progression of periodontal disease by disrupting the immune system and impairing the body's ability to control the microbial biofilms that contribute to the disease. Additionally, behaviours such as smoking and poor oral hygiene, which are often exacerbated by chronic stress, can further increase the risk of periodontal disease. Numerous studies have reported a bidirectional relationship between stress and periodontal disease. That is, while stress can contribute to the onset and progression of periodontal disease, the presence of periodontal disease can, in turn, exacerbate psychological stress. Despite this understanding, the exact pathogenesis of how stress affects periodontal disease remains unclear. Allostatic load provides a method for measuring the cumulative physiological effects of stress, making it a valuable tool for studying the relationship between stress and disease. This study aims to bridge this gap by examining the association between allostatic load with staging and grading of periodontitis, with a specific focus on evaluating the effects of subgingival instrumentation on allostatic load in patients with periodontitis. By addressing this critical gap in the literature, this research will contribute to a more comprehensive understanding of the interconnectedness of oral and systemic health and offer new avenues for improving patient care.
- Conditions
- Allostatic Load, Periodontitis, Chronic
- Being tested
- Sub-gingival instrumentation
- Keywords
- periodontitis, inflammation, allostatic load
- Medical subject headings
- Chronic Periodontitis, Periodontitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-gingival instrumentationProcedure or surgery
All patients will undergo dental biofilm control through patient motivation, oral hygiene instructions and supragingival professional mechanical plaque removal followed by sub-gingival instrumentation.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | Experimental | Stage II/III Periodontitis Receives: Procedure: Sub-gingival instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
C- Reactive protein
It measures the level of inflammation in the body. Elevated CRP levels indicate infection, inflammation or disease.
Measured: Baseline, 3 months
HbA1c(glycated hemoglobin)
It measures the average level of glucose attached to hemoglobin in red blood cells over the past 2-3 months.
Measured: baseline, 3 months
High Density Lipoprotein
It measures the amount of high density lipoprotein cholesterol level in the blood, with lower levels indicating a higher score.
Measured: baseline, 3 months
Bleeding on Probing
It will be recorded as bleeding occurring within 15 seconds of probing.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start10 Jun 2025
- Primary completion10 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allostatic LoadStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978712
- Sponsor's protocol ID
- Gaytri Perio 25/35
- Status last verified
- May 2026
- First submitted
- 7 May 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Subgingival Instrumentation on Allostatic Load in Periodontitis
- ClinicalTrials.gov ID
- NCT06978712
- Acronym / sponsor ID
- Gaytri Perio 25/35
- Conditions
- Allostatic Load, Periodontitis, Chronic
- Keywords
- periodontitis, inflammation, allostatic load
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 May 2025 (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.
Periodontitis is a prevalent global health issue that contributes to systemic inflammation and is closely linked to stress as a risk factor. Both conditions have been investigated for bidirectional relationship. However, the results are inconsistent, and the mechanistic links remain unclear. Allostatic load, which measures the cumulative biological effects of stress, may be relevant in elucidating this connection. Inconsistent results have been reported in previous studies exploring the association between periodontitis and individual biomarkers of allostatic load. Furthermore, none of these studies has taken into consideration staging and grading of periodontitis. Additionally, while periodontal treatment has been shown to reduce both local and systemic inflammation, its effect on allostatic load remains unexplored till date. This study aims to fill these gaps by evaluating the relationship between these parameters of periodontitis and allostatic load. Evaluation of impact of subgingival instrumentation on allostatic load may further provide insights into the broader systemic benefits of periodontal interventions.
Detailed description
Stress is a significant risk factor for various chronic diseases, such as cardiovascular conditions, diabetes, and obesity, all of which have severe implications for public health. The relationship between stress and these chronic conditions is complex, involving both direct physiological changes and behavioural adaptations that affect health outcomes. While acute stress responses can be adaptive, chronic stress can lead to dysregulation of the body's homeostatic processes which results in allostatic load, refers to the cumulative physiological toll that the body experiences over time due to repeated or prolonged stress. Allostatic load disrupts the normal functioning of various bodily systems, including the cardiovascular, metabolic, and immune systems, which can lead to long-term health consequences such as hypertension, diabetes, and autoimmune diseases. dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic nervous system (SNS) during chronic stress is associated with elevated biomarkers such as cortisol, epinephrine, and dehydroepiandrosterone sulfate (DHEA-S). These biomarkers, along with other indicators like blood pressure, cholesterol, glycated haemoglobin (HbA1c), and C-reactive protein (CRP), serve as proxies for allostatic load and are critical in understanding the body's response to stress over time. Beyond its systemic effects, stress also plays a pivotal role in oral health. Chronic stress is known to increase inflammation, impair immune responses, and alter hormone levels, all of which contribute to the development and progression of oral diseases, including periodontal disease and dental caries. Stress-induced allostatic load is thought to play a role in the onset and progression of periodontal disease by disrupting the immune system and impairing the body's ability to control the microbial biofilms that contribute to the disease. Additionally, behaviours such as smoking and poor oral hygiene, which are often exacerbated by chronic stress, can further increase the risk of periodontal disease. Numerous studies have reported a bidirectional relationship between stress and periodontal disease. That is, while stress can contribute to the onset and progression of periodontal disease, the presence of periodontal disease can, in turn, exacerbate psychological stress. Despite this understanding, the exact pathogenesis of how stress affects periodontal disease remains unclear. Allostatic load provides a method for measuring the cumulative physiological effects of stress, making it a valuable tool for studying the relationship between stress and disease. This study aims to bridge this gap by examining the association between allostatic load with staging and grading of periodontitis, with a specific focus on evaluating the effects of subgingival instrumentation on allostatic load in patients with periodontitis. By addressing this critical gap in the literature, this research will contribute to a more comprehensive understanding of the interconnectedness of oral and systemic health and offer new avenues for improving patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | Experimental | Procedure: Sub-gingival instrumentationStage II/III Periodontitis |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with age group 30-50 years diagnosed with generalized periodontitis.
- Presence of minimum 20 teeth excluding third molars.
Key exclusion criteria (5 listed)
- Periodontal treatment within last 6 months
- History of antibiotic use within the previous 3 months
- History of use of steroid, immunosuppressive and psychiatric drugs
- Pregnant and lactating women
- History of substance abuse
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 |
|---|---|---|
| Sub-gingival instrumentationAll patients will undergo dental biofilm control through patient motivation, oral hygiene instructions and supragingival professional mechanical plaque removal followed by sub-gingival instrumentation. | Procedure or surgery | Periodontitis |
Primary outcome
C- Reactive protein
Time frame: Baseline, 3 months
It measures the level of inflammation in the body. Elevated CRP levels indicate infection, inflammation or disease.
HbA1c(glycated hemoglobin)
Time frame: baseline, 3 months
It measures the average level of glucose attached to hemoglobin in red blood cells over the past 2-3 months.
High Density Lipoprotein
Time frame: baseline, 3 months
It measures the amount of high density lipoprotein cholesterol level in the blood, with lower levels indicating a higher score.
Bleeding on Probing
Time frame: Baseline, 3 months
It will be recorded as bleeding occurring within 15 seconds of probing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-gingival instrumentation in people with Allostatic Load and Periodontitis, Chronic, 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajinder K Sharma, MDS (+919416358222, rksharmamds@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C- Reactive protein (time frame: Baseline, 3 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?
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 May 2026.