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
|Condition or disease||Intervention/treatment||Phase|
|Combat and Operational Stress Reaction||Behavioral: Stress Reduction Protocol||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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.
- Clinical attachment level [ Time Frame: 3 months ]
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
|Contact: Karthikeyan BV, MDSfirstname.lastname@example.org|
|Krishnadevaraya College of dental sciences||Recruiting|
|Banglore, Karnataka, India, 562157|
|Contact: Karthikeyan BV, MDS +919449545157 email@example.com|
|Study Director:||Karthikeyan BV, MDS||Krishnadevaraya College of Dental Sciences|