Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04259242 |
| Other study ID # |
Pradeep perio |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
January 31, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To assess the impact of scaling and root planing on systemic inflammation and serum bone
resorption markers in pre-menopausal women with periodontitis
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 ).
