Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06048016 |
| Other study ID # |
PER7_2_1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2023 |
| Est. completion date |
July 10, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Cairo University |
| Contact |
Zahraa AF Nasser, Master's |
| Phone |
01127670057 |
| Email |
zahraa.a.nasser[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this [interventional clinical trial] is to test effect of scaling and root
plaining on Alkaline phosphatase in Saliva and Gingival crevicular fluid in periodontitis
patients compared with healthy subjects The population from periodontitis patients compared
with healthy individuals
It aims to answer are:
• 1_Alkaline phosphatase level in saliva and GCF. 2_Scaling and root plaining effect on
Alkaline Phosphatase level. 0 participants will be asked to maintain their oral hygiene
instructions.
Researchers will compare [periodontitispatientsto healthyindividuals] to see if
[AlkalinePhosphatase level].
Description:
Periodontitis is a chronic inflammatory disease that destroys the periodontium and is the
leading cause of adult tooth loss (Hajishengallis 2014). Periodontitis causes systemic
inflammation and immune response via microorganisms and their products in subgingival plaque
biofilm, and it is a risk factor for systemic diseases (Lim et al. 2020).
Diagnosis of periodontal disease is made after analyzing the information collected from a
periodontal examination. Traditional periodontal diagnostic parameters used clinically
include probing depths, bleeding on probing, clinical attachment levels, plaque index and
radiographs assessing alveolar bone level (Taba et al. 2005).
The aim of periodontal diagnostic procedures is to provide the clinician with useful
information about the current periodontal disease type, location, and severity. These
findings form the foundation for treatment planning and provide critical information during
the periodontal maintenance and disease-monitoring phases of treatment (Taba et al. 2005).
Traditional diagnostic procedures are inherently limited, in that only disease history, not
current disease status, can be assessed. Advances in diagnostic research in oral and
periodontal disease are moving toward methods whereby periodontal risk can be identified and
quantified by objective measures such as biomarkers (Sanikop S et al.2012).
A biomarker is a substance that indicates a biological state and serves as an objective
measure to assess current and future disease activity (Pavankumar et al. 2015). The response
of an organism to periodontal infection includes production of several enzymes released from
stromal, epithelial, inflammatory, or bacterial cells. These intracellular enzymes are
released increasingly from the damaged cells of periodontal tissues into the gingival
crevicular fluid (GCF) and saliva (Sanikop S et al.2012).
Saliva contains the body's most important electrolytes (calcium, phosphorous and other
minerals). They get a significant impact on the formation, maturation, and metabolism of
dental plaque. Salivary calcium and phosphorus concentrations are important for periodontal
health because an increased level of salivary calcium or phosphorous is associated with
rapidly mineralized plaque, which is associated with poor oral hygiene. As a result, salivary
biomarkers such as calcium, phosphorus, alkaline phosphatase, and pH can be used to assess
the diagnosis and prognosis of gingivitis or periodontitis(Alaauldeen et a2015).
Gingival crevicular fluid (GCF) has greatly aided our understanding of periodontal disease
pathogenesis. A very small amount of fluid analysis may reveal significant clinical changes
occurring within the gingiva. These modifications may be useful in the diagnosis of
periodontal disease (Koregol et al. 2011). GCF is regarded as a promising medium for the
detection of markers of periodontal disease activity. Periodontal diseases are characterised
by the destruction of tooth-supporting tissues, and quantitation of tissue breakdown products
in GCF has been pursued as a means of identifying active disease sites (Koregol et al. 2011).
Alkaline phosphatase is a catalytic enzyme that accelerates the removal of phosphate groups
in the 5 and 3 positions from a wide range of molecules such as nucleotides, proteins, and
alkaloids. Although ALP is found in all tissues, it is especially abundant in the bone,
liver, bile duct, kidney, and placenta(Pavankumar et al. 2015). It is a membrane bound
glycoprotein produced by many cells such as neutrophils during inflammation, osteoblasts
during bone production, and periodontal ligament fibroblasts during regeneration. ALP is
regarded as a critical indication of osteoblastic activity. The presence of ALP in the saliva
and GCF is usually indicative of inflammation and/or destruction of the periodontal tissues.
The level of ALP is positively correlated with the severity of the periodontal disease
(Pavankumar et al. 2015).
The normal level of ALP in the human blood ranges from 25 to 100 IU/L when the concentration
of ALP is higher than 300 IU/L, it is an indicator of several diseases including liver
diseases, liver cancer, hepatitis, bone disease, osteoblastic bone cancer (Wang et al.,
2009).
