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Role of Stress Reduction Protocol on Outcome of Periodontal Therapy

Primary Purpose

Combat and Operational Stress Reaction

Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Stress Reduction Protocol
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Combat and Operational Stress Reaction

Eligibility Criteria

30 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • patients within the age group of 30 to 55 years,
  • systemically healthy stressed & unstressed individuals with chronic periodontitis and
  • who were co-operative and willing to attend follow up visits

Exclusion Criteria:

  • patients on corticosteroids and antipsychotic drug therapy,
  • who had received any periodontal therapy,
  • surgical or non- surgical within the past six months of baseline examination,
  • Smokers,
  • no prior history of non-surgical periodontal therapy within 6 months,
  • with less than 20 permanent teeth remaining,
  • history of psychiatric treatment within past 6 months,
  • known systemic diseases and conditions.

Sites / Locations

  • Krishnadevaraya College of dental sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

No Intervention

Arm Label

Screening

catagerizing the study population

Stress Reduction Protocol

Arm Description

Participants were screened for the inclusion and exclusion criteria to select the study group. No intervention has been done.

The selected participants where assigned into respective groups

Participants were evaluated for the outcome of the intervention.

Outcomes

Primary Outcome Measures

Clinical attachment level

Secondary Outcome Measures

Full Information

First Posted
May 12, 2015
Last Updated
November 20, 2015
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02487862
Brief Title
Role of Stress Reduction Protocol on Outcome of Periodontal Therapy
Official Title
Evaluating the Adjunctive Effect of Stress Reduction Protocol in the Non-Surgical Periodontal Therapy of Chronic Periodontitis Subjects Associated With Stress: A Randomized Control Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Psychological conditions, particularly psychosocial stress, have been implicated as risk indicators for periodontal disease. Minimal evidence in literature exists to assess the effect of stress reduction therapy (SRT) in the outcome of non-surgical periodontal therapy (NSPT). Hence, the present study was aimed at exploring the possibility of employing SRT in stressed subjects (assessed using questionnaire data and serum cortisol level) as an adjunctive intervention in the management of periodontal diseases.
Detailed Description
Periodontitis is a multifactorial disease where microbial dental biofilms are considered to be a key etiological agent for the initiation & progression of the inflammatory process. Apart from the microbial biofilms, several other risk factors have been associated with increased susceptibility, progression and severity of periodontal diseases such as systemic diseases, genetic polymorphisms, socio-economic or educational status, tobacco smoking, oral hygiene level and psychological stress. With respect to other possible factors influencing chronic periodontitis, more direct evidence has emerged that stress, depression and anxiety contribute to the development of periodontitis in odds ratio of 1:2. Further, it has been shown that subjects with stress are more prone to develop periodontal disease than subjects without stress. It is speculated that chronic stress contribute to the development of periodontitis by having a net negative effect on the immunological response of body or by health related risk behaviors such as smoking, over eating and lessen compliance with the preventive behavior or even both. In addition, it has been found that patients experiencing stress were slower in recovery from periodontal treatment compared to subjects who are not experiencing stress. Interestingly, the impact of stress on the pathogenesis and periodontal treatment outcomes depends upon the individuals coping ability. Literature evidence shows that emotional-focused coping individuals (defensive coping, resigned coping, distractive coping which are advantageous in the short term) have more advanced disease and poor response to non-surgical periodontal treatment when compared to problem focused coping (i.e. active coping). Hence, assessment of a patient's stress level, their coping ability and stress management might be of value in understanding psychological effects on periodontal health and its disease process, which will be helpful in future preventive care. Considering these facts, we hypothesize that if stress is causally related to the worsening of parameters in a chronic periodontitis patient, its alleviation might result in an additive response to the conventional periodontal therapy. However, till date, there are no intervention studies on possibility of employing psychological intervention (stress reduction therapy) as adjunctive measure in the treatment of periodontitis subjects with unfavorable psychological background. Hence, considering this hypothesis, the present study is conducted which is first of its kind, to explore and evaluate, if intervention focused on stress management enhancement training may serve as adjunctive role in non-surgical treatment of periodontal diseases by monitoring the improvements in periodontal condition through clinical parameters and correlating with stress marker like salivary cortisol levels and Derogatis stress profile (DSP) scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Combat and Operational Stress Reaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening
Arm Type
No Intervention
Arm Description
Participants were screened for the inclusion and exclusion criteria to select the study group. No intervention has been done.
Arm Title
catagerizing the study population
Arm Type
Placebo Comparator
Arm Description
The selected participants where assigned into respective groups
Arm Title
Stress Reduction Protocol
Arm Type
No Intervention
Arm Description
Participants were evaluated for the outcome of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Stress Reduction Protocol
Intervention Description
Stress Reduction Protocol
Primary Outcome Measure Information:
Title
Clinical attachment level
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients within the age group of 30 to 55 years, systemically healthy stressed & unstressed individuals with chronic periodontitis and who were co-operative and willing to attend follow up visits Exclusion Criteria: patients on corticosteroids and antipsychotic drug therapy, who had received any periodontal therapy, surgical or non- surgical within the past six months of baseline examination, Smokers, no prior history of non-surgical periodontal therapy within 6 months, with less than 20 permanent teeth remaining, history of psychiatric treatment within past 6 months, known systemic diseases and conditions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karthikeyan BV, MDS
Phone
+919449545157
Email
drkarthikeyanbv@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karthikeyan BV, MDS
Organizational Affiliation
Krishnadevaraya College of Dental Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Krishnadevaraya College of dental sciences
City
Banglore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karthikeyan BV, MDS
Phone
+919449545157
Email
drkarthikeyanbv@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
12840146
Citation
Kiecolt-Glaser JK, Preacher KJ, MacCallum RC, Atkinson C, Malarkey WB, Glaser R. Chronic stress and age-related increases in the proinflammatory cytokine IL-6. Proc Natl Acad Sci U S A. 2003 Jul 22;100(15):9090-5. doi: 10.1073/pnas.1531903100. Epub 2003 Jul 2.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/12840146
Description
Reference Article

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Role of Stress Reduction Protocol on Outcome of Periodontal Therapy

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