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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Rajinder K Sharma, MDS contact

+919416358222

rksharmamds@yahoo.in

India1 site, 1 recruiting
  • PGIDS

    Rohtak, Haryana, 124001

    Rajinder K Sharma, MDS, +919416358222, rksharmamds@yahoo.in

    Sanjay Tewari, MDS, 01262-297876, principal.pgids@uhsr.ac.in

    Recruiting

Other trials in India

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.

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 groups in NCT06978712
Study groupRoleWhat they receive
PeriodontitisExperimentalStage 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.

  1. C- Reactive protein

    It measures the level of inflammation in the body. Elevated CRP levels indicate infection, inflammation or disease.

    Measured: Baseline, 3 months

  2. 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

  3. 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

  4. 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.

  1. First posted18 May 2025
  2. Study start10 Jun 2025
  3. Primary completion10 Jun 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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)
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

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.

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