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Combat and Operational Stress ReactionPhase 4NCT02487862

Role of Stress Reduction Protocol on Outcome of Periodontal Therapy

A Phase 4 study testing Stress Reduction Protocol in people with Combat and Operational Stress Reaction, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Combat and Operational Stress Reaction
What is being tested?
Stress Reduction Protocol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteIndia
Study dates
Feb 2015to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Karthikeyan BV, MDS contact

+919449545157

drkarthikeyanbv@gmail.com

India1 site, 1 recruiting
  • Krishnadevaraya College of dental sciences

    Banglore, Karnataka, 562157

    Karthikeyan BV, MDS, +919449545157, drkarthikeyanbv@gmail.com

    Recruiting

Other trials in India

About this study

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

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.

Read the 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.

Being tested
Stress Reduction Protocol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stress Reduction ProtocolBehavioural

    Stress Reduction Protocol

Study groups in NCT02487862
Study groupRoleWhat they receive
ScreeningNo interventionParticipants were screened for the inclusion and exclusion criteria to select the study group. No intervention has been done.
catagerizing the study populationPlacebo comparatorThe selected participants where assigned into respective groups
Receives: Behavioral: Stress Reduction Protocol
Stress Reduction ProtocolNo interventionParticipants were evaluated for the outcome of the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical attachment level

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionSep 2015
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02487862
Sponsor's protocol ID
KCDS
Status last verified
Sep 2015
First submitted
12 May 2015
Last updated
24 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12840146

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stress Reduction Protocol in people with Combat and Operational Stress Reaction, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karthikeyan BV, MDS (+919449545157, drkarthikeyanbv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical attachment level (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02487862, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2015.

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