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Role of Stress Reduction Protocol on Outcome of Periodontal Therapy

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ClinicalTrials.gov Identifier: NCT02487862
Recruitment Status : Unknown
Verified September 2015 by Krishnadevaraya College of Dental Sciences & Hospital.
Recruitment status was:  Recruiting
First Posted : July 2, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Krishnadevaraya College of Dental Sciences & Hospital

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.

Condition or disease Intervention/treatment Phase
Combat and Operational Stress Reaction Behavioral: Stress Reduction Protocol Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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 Start Date : February 2015
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
No Intervention: Screening
Participants were screened for the inclusion and exclusion criteria to select the study group. No intervention has been done.
Placebo Comparator: catagerizing the study population
The selected participants where assigned into respective groups
Behavioral: Stress Reduction Protocol
Stress Reduction Protocol

No Intervention: Stress Reduction Protocol
Participants were evaluated for the outcome of the intervention.



Primary Outcome Measures :
  1. Clinical attachment level [ Time Frame: 3 months ]


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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487862


Contacts
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Contact: Karthikeyan BV, MDS +919449545157 drkarthikeyanbv@gmail.com

Locations
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India
Krishnadevaraya College of dental sciences Recruiting
Banglore, Karnataka, India, 562157
Contact: Karthikeyan BV, MDS    +919449545157    drkarthikeyanbv@gmail.com   
Sponsors and Collaborators
Krishnadevaraya College of Dental Sciences & Hospital
Investigators
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Study Director: Karthikeyan BV, MDS Krishnadevaraya College of Dental Sciences

Additional Information:
Publications of Results:
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Responsible Party: Krishnadevaraya College of Dental Sciences & Hospital
ClinicalTrials.gov Identifier: NCT02487862     History of Changes
Other Study ID Numbers: KCDS
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Fractures, Stress
Fractures, Bone
Wounds and Injuries