Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05115201 |
| Other study ID # |
Manpreet Kaur perio 2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 26, 2021 |
| Est. completion date |
June 10, 2022 |
Study information
| Verified date |
November 2021 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Evidence support that pathogenic bacteria are not only responsible for periodontal
destruction but also contributes to systemic inflammatory burden either directly or
indirectly through increase in pro-inflammatory cytokines. Scaling and root planing (SRP)
with or without local antibiotics contributes to reduced systemic inflammation. However,
studies also reported insignificant changes in systemic inflammation after SRP. It may be due
to incomplete control of periodontal inflammation. Systemic antibiotics proves to beneficial
in treatment of severe periodontitis. Systemic antibiotics along with SRP results in
improvement of vascular health and systemic inflammation. However, till date no study has
been done to evaluate the role of systemic antibiotics as an adjunct to SRP on systemic
inflammatory markers. In this randomized control study impact of adjunctive use of systemic
antibiotics along with SRP on systemic inflammation would be assessed in periodontitis
patients.
Description:
Periodontitis is characterized by microbially-associated, host-mediated inflammation that
results in loss of periodontal attachment. Periodontal bacteria possess a plethora of
virulence factors that induce cells to produce inflammatory mediators at the gingival level.
Periodontitis is associated with bacteraemia that arises from perturbation of ulcerated
periodontal tissues by simple acts of tooth brushing, eating and also during periodontal
interventions disseminating whole bacteria and their products and toxins such as LPS.
Virulence factors and bacteria itself interact with the host immune system and initiate
inflammatory responses.
Moreover, bacteria may persist at distal sites disseminating virulence factors that act as
soluble antigens thereby provocation leucocytes, endothelial cells and hepatocytes to respond
to bacteria/virulence factors with secretion of pro-inflammatory immune mediators [cytokines,
chemokines, C-reactive protein (CRP)]. With continued exposure, soluble antigens react with
circulating specific antibody to form immune complexes that further amplify inflammation at
sites of deposition.
In industrialized countries, approximately 50% of the adult population suffers from moderate
or severe periodontitis. Basic periodontal therapy usually comprises mechanical debridement
of the teeth. It is the disruption of biofilm, followed by lifelong maintenance therapy.
Traditional periodontal therapy involves elimination of periodontopathogens by mechanical
debridement, such as scaling and root planing (SRP) and surgical procedures in conjunction
with proper plaque control.
Because of the infective nature of periodontitis, pharmacologic agents have been advocated as
adjuncts in the non-surgical treatment of periodontal infection. The rationale for the
adjunctive use of antibiotics is to exert an antimicrobial effect at sites inaccessible to
mechanical therapy, and possibly to suppress periodontal pathogens. Moreover, absence of
specific periodontal pathogens seems to have a negative predictive value for further
attachment loss. Therefore, one objective of periodontal treatment might be to suppress or
eliminate certain subgingival periodontal pathogens. Adjunctive antibiotics have been
suggested to improve treatment outcomes in patients with severe chronic periodontitis and
aggressive periodontitis.
Because of amoxicillin and metronidazole's proven ability to suppress periodontal pathogens,
such as A. actinomycetemcomitans and black pigmented bacteria from periodontitis lesions and
other oral sites, it is the first choice of many clinicians, especially for the treatment of
advanced A. actinomycetemcomitans-associated periodontitis. These pathogenic bacteria are not
only restricted to oral cavity, but are associated with disease implication in other parts of
the body.
Evidence support that pathogenic bacteria are not only responsible for periodontal
destruction but also contributes to systemic inflammatory burden either directly or
indirectly through increase in pro-inflammatory cytokines. Scaling and root planing with or
without local antibiotics contributes to reduced systemic inflammation. However, studies also
reported insignificant changes in systemic inflammation after SRP. It may be due to
incomplete control of periodontal inflammation. Systemic antibiotics proves to beneficial in
treatment of severe periodontitis. Systemic antibiotics along with scaling and root planing
results in improvement of vascular health and systemic inflammation. However, till date no
study has been done to evaluate the role of systemic antibiotics as an adjunct to scaling and
root planing on systemic inflammatory markers.
In this randomized controlled clinical trial, impact of adjunctive use of systemic
antibiotics along with scaling and root planing on systemic inflammation would be assessed in
periodontitis patients.
Material and methods:
The present randomized clinical trial will be conducted in Department of Periodontics and
Oral Implantology, Post Graduate Institute of Dental Sciences, Rohtak. The study protocol is
according to the ethical standards of Helsinki Declaration 1975 as revised in 2013.
Study population:
Periodontally healthy individuals (PH) and stage III periodontitis patients of age 35-45
years will be recruited from outpatient department of Periodontics and Oral Implantology. The
patients will be enrolled after obtaining an informed consent.
Experimental design: This randomized clinical trial consists of two parallel groups based
intervention in periodontitis patients:
Periodontal parameters:
At baseline, periodontal parameters plaque index (PI), gingival index (GI), bleeding on
probing (BOP), probing pocket depth (PPD), 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 in all groups. Periodontal inflamed surface
area (PISA) will then be calculated. Periodontal examination would again be done during
recall visit after 2nd month in test group (TG) and control group (CG).
Periodontal therapy:
After recording periodontal parameters at baseline, oral hygiene instructions would be given
and scaling and root planing (SRP) would be done in both treatment groups (TG and CG). TG
will be given amoxicillin and metronidazole, 500mg and 400mg respectively (AMX+MTZ) to be
taken thrice daily for 7 days. Patients will inform about any self-perceived side-effects of
the medications. Any adverse effects from antibiotic intake and compliance, as reported by
patients, will be recorded throughout the study period. TG and CG would be recalled after
1stand 2nd month of SRP. At recall visit after 1 month, oral hygiene instructions will be
re-enforced and supportive periodontal therapy would be provided.
Blood collection and serum analysis:
For assessing markers of systemic inflammation, serum samples will be collected from
venipuncture in antecubital fossa after an overnight fasting.
Serum samples would be analyzed for systemic markers at baseline and after 2 months of
periodontal treatment in TG and CG.
Parameter of systemic inflammation that would be assessed:
• High sensitive C-reactive protein (hs CRP)
Blood parameters that would be assessed: Total leukocyte count(TLC), differential leukocyte
count (DLC), neutrophil lymphocyte ratio, platelet count, mean platelet volume (MPV),
platelet distribution width (PDW), platelet-to-lymphocyte ratio (PLR), red blood cell count
(RBC), hemoglobin (Hb), hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular
hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution
width (RDW)
Blood parameters that would be assessed: triglyceride (TG), total cholesterol (TC),
low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), very
low-density lipoprotein cholesterol (VLDL)
Anthropometric parameter that would be measured: Body Mass Index (BMI) calculated as
weight/height2 (Kg/m2) at baseline.
