Impact of SRP on Bone Resorption and Systemic Inflammatory Markers in Postmenopausal Women With Periodontitis
Condition: Periodontitis
MeSH terms: Bone Resorption; Periodontitis
Study type: Interventional

Summary: 
      This study is designed to determine the effect of treating postmenopausal women and using
      non-surgical techniques on biomarkers of systemic inflammation (IL-6 ) and systemic bone
      resorption (C-terminal collagen cross-links, CTX).
    

Detailed description: 
      Periodontitis is an inflammatory disease of tooth supporting tissues that is characterized by
      progressive loss of bone and periodontal attachment and which ultimately leads to tooth loss
      if left untreated. It is a widespread condition which affects 30% of the adult population.
      The prevalence increases to greater than 47% among adults age 30 years or older, with those
      over 65 years old accounting for most cases Osteoporosis is a disease characterized by low
      bone mineral density(BMD) and deterioration of bone microarchitecture, which leads to
      increased risk of fragility fractures. It has been reported that one out of two Indian
      females above the age of 50 years and one out of five Indian men above the age of 65 years
      are at risk of osteoporosis. It is apparent that both periodontitis and osteoporosis are
      chronic conditions characterized by resorptive osseous changes with multiple shared risk
      factors including age, genetics, hormonal change, smoking , as well as calcium and vitamin D
      deficiency. It has been proposed that the two diseases could also have a mutual relation and
      this has led to a considerable number of studies investigating the same .Both osteoporosis
      and periodontitis are more prevalent among elderly population. The number of patients who
      suffer from both periodontitis and osteoporosis is expected to rise as the average lifespan
      increases.

      Eighty percent of individuals with osteoporosis are women, largely due to the marked loss in
      bone density associated with the withdrawal of estrogen that accompanies loss of ovarian
      function at menopause. There is now strong evidence to suggest that systemic pro-inflammatory
      cytokines in response to estrogen withdrawal at menopause is responsible for increased
      osteoclastic activity.Systemic Inflammation results in an uncoupling between bone resorption
      and formation and favours excessive bone resorption resulting in decreased bone mineral
      density and increased fracture risk in postmenopausal women. Pro-inflammatory cytokines
      capable of stimulating osteoclastic bone resorption include IL-1, TNF-α, IL-6,IL-11, IL-15
      and IL-17. It has been demonstrated that while periodontitis is a local infectious disease of
      tooth supporting structures, it is also associated with higher inflammatory mediators in the
      systemic circulation. The data suggest that an individual's overall bone metabolism might be
      associated with periodontal disease and be reflective of its progression.

      Levels of bone turnover markers (BTM) reflect the activity and number of bone forming
      (osteoblasts) and bone-degrading (osteoclasts) cells, providing an estimate of bone
      resorption and bone formation. BTM can be measured non-invasively in either blood or urine at
      a fairly low cost. C-terminal collagen cross-links,CTX, is a bone resorption marker which
      consists of cross-linked telopeptides from collagen which are released during enzymatic
      degradation of bone matrix by the osteoclasts Scaling and root planing (SRP) is the most
      accepted treatment for managing chronic periodontitis and is proven to be effective at
      controlling local inflammation. Recent research has found evidence that levels of systemic
      inflammatory markers including IL-1, TNF-α, and IL-6 are also reduced after SRP. Therefore,
      treatment of periodontal disease results in reduced systemic inflammation but it is unknown
      if this translates to better outcomes for management of osteoporosis. It is hypothesized that
      if periodontitis has an influence on bone remodeling, then levels of BTM would also vary with
      decrease in systemic inflammation owing to resolution of periodontal inflammation following
      non-surgical periodontal treatment. The purpose of this study is to determine the effect of
      treating periodontal disease in patients with osteoporosis with scaling and root planing on
      biomarkers of systemic inflammation (IL-6) and systemic bone turnover (CTX). It is
      anticipated that the results of this study could be useful in formulating recommendations for
      interdisciplinary management of patients of concomitant periodontitis and osteoporosis.

      MATERIALS AND METHODOLOGY

      STUDY DESIGN SETTING: The present prospective interventional study will be conducted in
      department of Periodontology , Post Graduate institute Dental Sciences,Rohtak.

      STUDY PERIOD: 14 months STUDY POPULATION : Patients will be recruited from out patient
      department of Periodontology.

      METHODOLOGY The study will be conducted as follows .

      METHOD OF RECRUITMENT:

      Post-menopausal females diagnosed with stage 2 and stage 3 periodontitis will be recruited
      from the outpatient department of Periodontology. Only those patients who consent for the
      study will be included after obtaining an informed written consent. Those who fulfill the
      inclusion criteria will be enrolled in the study. Clinical periodontal parameters (CAL, PD
      and BOP) will be recorded and venous blood samples for measuring serum levels of IL-6 and
      sCTX will be collected. Scaling and root planing will be performed in all cases. All patients
      will be re-evaluated after 8 weeks for recording clinical periodontal parameters and serum
      inflammatory and bone resorption markers as before.

      INTERVENTION Full mouth scaling and root planing (SRP) will be performed for all participants
      with both ultrasonic instruments and manual instrumentation using scalers and curettes. All
      patients will be given instructions for maintaining proper oral hygiene using soft toothbrush
      and fluoridated toothpaste. No mouthwashes will be prescribed.

      FOLLOW UP OF STUDY PARTICIPANTS All participants will be evaluated for clinical periodontal
      parameters (PD, CAL and BOP) at 8 weeks after completion of SRP. Serum inflammatory (IL-6)
      and bone resorption markers (CTX) will be evaluated only for those participants in whom <10 %
      bleeding sites .

      BODY MASS INDEX (BMI) BMI=Weight(kg)/Height²(m²)

      BIOCHEMICAL PARAMETERS Venous blood from the anticubital vein will be collected after
      overnight fasting after applying a tourniquet in a plain vacutainer tube without additive.
      Immediately after collection of blood samples,the samples will be centrifuged, and separated
      serum and plasma will be stored at -80̊ c until processed. The level of following biomarkers
      will be evaluated using ELISA kits- IL-6,sCTX All the blood samples will be collected at the
      baseline and 8 weeks following SRP.
    

Intervention name(s): scaling and root planing
Intervention type(s): Procedure
Intervention description(s): scaling and root planing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment