- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06978712
- Original Trial
Impact of Periodontal Inflammation on Allostatic Load
May 21, 2026 updated by: Postgraduate Institute of Dental Sciences Rohtak
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rajinder K Sharma, MDS
- Phone Number: +919416358222
- Email: rksharmamds@yahoo.in
Study Contact Backup
- Name: Gaytri, BDS
- Phone Number: +919991092061
- Email: gaytrilalit2@gmail.com
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Recruiting
- PGIDS
-
Contact:
- Rajinder K Sharma, MDS
- Phone Number: +919416358222
- Email: rksharmamds@yahoo.in
-
Contact:
- Sanjay Tewari, MDS
- Phone Number: 01262-297876
- Email: principal.pgids@uhsr.ac.in
-
Sub-Investigator:
- Rajinder K Sharma, MDS
-
Principal Investigator:
- Gaytri, BDS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with age group 30-50 years diagnosed with generalized periodontitis.
- Presence of minimum 20 teeth excluding third molars.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Periodontitis
Stage II/III Periodontitis
|
All patients will undergo dental biofilm control through patient motivation, oral hygiene instructions and supragingival professional mechanical plaque removal followed by sub-gingival instrumentation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 3 months
|
|
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.
|
baseline, 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.
|
baseline, 3 months
|
|
Bleeding on Probing
Time Frame: Baseline, 3 months
|
It will be recorded as bleeding occurring within 15 seconds of probing.
|
Baseline, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2025
Primary Completion (Estimated)
June 10, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
May 7, 2025
First Submitted That Met QC Criteria
May 16, 2025
First Posted (Actual)
May 18, 2025
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gaytri Perio 25/35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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