- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02487862
Role of Stress Reduction Protocol on Outcome of Periodontal Therapy
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Karthikeyan BV, MDS
- Phone Number: +919449545157
- Email: drkarthikeyanbv@gmail.com
Study Locations
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Karnataka
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Banglore, Karnataka, India, 562157
- Recruiting
- Krishnadevaraya college of dental sciences
-
Contact:
- Karthikeyan BV, MDS
- Phone Number: +919449545157
- Email: drkarthikeyanbv@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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
|
Stress Reduction Protocol
|
No Intervention: Stress Reduction Protocol
Participants were evaluated for the outcome of the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical attachment level
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Karthikeyan BV, MDS, Krishnadevaraya college of dental sciences
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCDS
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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