SRP, Systemic Inflammation and Serum Bone Resorption Markers Premenopausal Women With Periodontitis and Low BMD
Condition: Periodontitis
MeSH terms: Bone Resorption; Periodontitis; Inflammation
Study type: Interventional

Summary: 
      To assess the impact of scaling and root planing on systemic inflammation and serum bone
      resorption markers in pre-menopausal women with periodontitis
    

Detailed description: 
      Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic
      plaque biofilms and characterized by progressive destruction of the tooth supporting
      apparatus. Its primary features include the loss of periodontal tissue support, manifested
      through clinical attachment loss (CAL) and radiographically assessed alveolar bone loss,
      presence of periodontal pocketing and gingival bleeding.

      Periodontitis is multifactorial inflammatory disease with numerous systemic or local risk
      factors playing a part in its clinical sequences. Periodontitis causes increased local
      inflammation as well as contributes to systemic inflammation with an increase in the levels
      of local and systemic inflammatory mediators including tumor necrosis factor alpha (TNF-α),
      interleukin-1 and interleukin-6 (IL-6).

      Osteoporosis is a systemic skeletal disease characterized by low bone mass and
      microarchitectural deterioration of bone tissue, with a consequent increase bone fragility
      and susceptibility to fracture.

      The development of osteoporosis occurs through spontaneous increase in pro-inflammatory and
      pro-osteoclastic cytokines such as , IL-6 and IL-1 β that activates receptor activator of
      nuclear factor-Kb ligand (RANKL) leading to an enhanced ability of osteoclasts to resorb
      bone.

      The Studies on systemic influence of periodontitis have suggested that locally produced
      proinflammatory cytokines such as IL-1β , TNF-α and IL-6 may be released into circulation.
      Most studies shows that IL-6 and TNF-α is major cytokine responsible for resorption of bone
      in osteoporosis and increase of bone turnover markers. Periodontitis is chronic inflammatory
      disease characterized by destruction of tooth supporting tissues by virtue of the immunologic
      response to bacterial challenge originating from dental plaque. In Periodontitis, the
      increased released of proinflammatory cytokines such as TNF- α, IL-1β, and IL-6 in systemic
      circulation which causes increase in systemic bone loss through their osteoclastic activity.
      The systemic inflammation and rate of bone loss is measured by systemic inflammatory and bone
      resorption markers respectively.

      Till date there is no conclusive interventional study done on impact of management of
      periodontitis on systemic inflammation and bone resorption markers(serum CTX) in
      pre-menopausal women with periodontitis .

      METHODOLOGY The study will be conducted as follows This prospective interventional study will
      be conducted in the department of Periodontics and Oral Implantology, Post Graduate Institute
      of Dental Sciences (PGIDS), Rohtak.

      Periodontitis patients will be recruited from the outpatient department of PGIDS, Rohtak.

      Sample Size calculation:

      Sample size was calculated using G power software using t test to compare difference between
      two matched (dependent) means . Total sample size was calculated as 19. A total of 24
      patients will be recruited expecting a 25% dropout rate.

      Periodontal parameters:

      At baseline, periodontal parameters plaque index (PI), gingival index (GI), bleeding on
      probing (BOP), probing depth (PD), clinical attachment loss (CAL) will be assessed at six
      sites (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual)
      per tooth excluding third molars. Periodontal examination would be performed at baseline and
      8 weeks after scaling and root planing.

      Periodontal therapy:

      After recording periodontal parameters at baseline, oral hygiene instructions would be given
      and scaling and root planning would be done. Patient would be recalled at after 8 weeks of
      complete scaling and root planing.

      Blood collection and serum analysis:

      For assessing markers of systemic inflammation and bone resorption, serum samples will be
      collected from venipuncture in antecubital fossa at 8 hours and after an overnight fasting
      for all subjects at baseline in individuals meeting the inclusion criteria. Serum samples
      would again be analyzed for systemic markers at 8 weeks after scaling and root planing in
      individuals who have bleeding on probing (BOP) less than 10% of the total sites.

      Parameters of systemic inflammation that would be assessed:

      Interleukin-6 (IL-6) Total leukocyte count(TLC) Differential leukocyte count (DLC) Platelet
      count Neutrophil/lymphocyte ratio (N/L) mean platelet volume platelet distribution width

      Systemic marker of bone resorption that would be analyzed:

      Serum C-terminal telopeptide of type 1 collagen (s-CTX-1)

      Anthropometric parameter that would be measured:

      Body Mass Index (BMI) calculated as weight/height 2 (Kg/m2)

      METHOD:

      Pre-menopausal women having stage 2 or stage 3 periodontitis would be enrolled to participate
      in the study. Those who fulfill the inclusion criteria would be enrolled in the study
      clinical periodontal parameters(CAL,PD,and BOP) would be recorded and venous blood samples
      for measuring serum levels of IL-6, and serum CTX-1 would be collected. Scaling and root
      planing would be performed in all cases.

      Patients would be re-evaluated after 8 weeks for recording all the periodontal parameters and
      systemic inflammation (IL-6 ) and systemic resorption marker (serum CTX-1 ).
    

Intervention name(s): SRP
Intervention type(s): Procedure
Intervention description(s): scaling and root planing with ultrasonic scaler and manual instruments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention