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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 24, 2015
September 1, 2015
7 months
May 12, 2015
November 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical attachment level
3 months
Study Arms (3)
Screening
NO INTERVENTIONParticipants were screened for the inclusion and exclusion criteria to select the study group. No intervention has been done.
catagerizing the study population
PLACEBO COMPARATORThe selected participants where assigned into respective groups
Stress Reduction Protocol
NO INTERVENTIONParticipants were evaluated for the outcome of the intervention.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Krishnadevaraya College of dental sciences
Banglore, Karnataka, 562157, India
Related Publications (1)
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.
PMID: 12840146RESULT
Related Links
Study Officials
- STUDY DIRECTOR
Karthikeyan BV, MDS
Krishnadevaraya College of Dental Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2015
First Posted
July 2, 2015
Study Start
February 1, 2015
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
November 24, 2015
Record last verified: 2015-09