Impact of Periodontal Inflammation on Allostatic Load

NCT06978712 | Not Yet Recruiting DMC

• 1 other identifier: Gaytri Perio 25/35
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allostatic Load; Periodontitis, Chronic

Keywords

periodontitis; inflammation; allostatic load

Outcome Measures

Primary Outcomes (4)

• C- Reactive protein

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

  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.

  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.

  baseline, 3 months

• Bleeding on Probing

  It will be recorded as bleeding occurring within 15 seconds of probing.

  Baseline, 3 months

Study Arms (1)

Periodontitis

EXPERIMENTAL

Stage II/III Periodontitis

Procedure: Sub-gingival instrumentation

Interventions

Sub-gingival instrumentation PROCEDURE

All patients will undergo dental biofilm control through patient motivation, oral hygiene instructions and supragingival professional mechanical plaque removal followed by sub-gingival instrumentation.

Periodontitis

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with age group 30-50 years diagnosed with generalized periodontitis.
• Presence of minimum 20 teeth excluding third molars.

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis; Inflammation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rajinder K Sharma, MDS

CONTACT

+919416358222; rksharmamds@yahoo.in

Gaytri, BDS

CONTACT

+919991092061; gaytrilalit2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 18, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)