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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
India1 site, 1 recruiting
- Recruiting
Krishnadevaraya College of dental sciences
Banglore, Karnataka, 562157
Karthikeyan BV, MDS, +919449545157, drkarthikeyanbv@gmail.com
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.
- Conditions
- Combat and Operational Stress Reaction
- 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 group | Role | What they receive |
|---|---|---|
| Screening | No intervention | Participants were screened for the inclusion and exclusion criteria to select the study group. No intervention has been done. |
| catagerizing the study population | Placebo comparator | The selected participants where assigned into respective groups Receives: Behavioral: Stress Reduction Protocol |
| Stress Reduction Protocol | No intervention | Participants 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.
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.
- First posted2 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Combat and Operational Stress ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karthikeyan BV, MDS, Study director, Krishnadevaraya College of Dental Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02487862
- Acronym / sponsor ID
- KCDS
- Conditions
- Combat and Operational Stress Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening | No intervention | –Participants were screened for the inclusion and exclusion criteria to select the study group. No intervention has been done. |
| catagerizing the study population | Placebo comparator | Behavioral: Stress Reduction ProtocolThe selected participants where assigned into respective groups |
| Stress Reduction Protocol | No intervention | –Participants were evaluated for the outcome of the intervention. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Reduction ProtocolStress Reduction Protocol | Behavioural | catagerizing the study population |
Primary outcome
Clinical attachment level
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Results publication: PubMed 12840146Kiecolt-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.
- Reference ArticleLink provided by the sponsor.
Related trials for Combat and Operational Stress Reaction
Recruiting
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PTSD, Military Activity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karthikeyan BV, MDS study director
Krishnadevaraya College of Dental Sciences
1 site in 1 country: see every site and its status.
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.