Effect Of Scaling and Root Planning on ALP in Saliva and GCF In Periodontitis Patients Compared With Healthy Individuals
Primary Purpose
Periodontitis, Healthy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Scaling and Root Planning
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring ALP, Scaling, GCF, Saliva, Periodontitis, Health
Eligibility Criteria
Inclusion Criteria: periodontitis patients stage I,II,III,IV Having more than 10 remaining teeth. • Systemically free Exclusion Criteria: infectious diseases dependent on antibiotics. .inflammatory diseases depend on analgesics. . Diabetes mellites patients . Hypertensive patients .Thyroid disease Patients who had professional periodontal treatment during the last 6 months. Pregnancy or lactation. Smokers.
Sites / Locations
- Zahraa NasserRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
periodontitis patients
Arm Description
Periodontitis Patients participate to test level of ALP in saliva and GCF.
Outcomes
Primary Outcome Measures
Effect Of Scaling and Root Planning on Alkaline Phosphatase level in saliva and GCF
Measuring ALP level in Saliva and Gingival crevicular before and after treatment
Secondary Outcome Measures
Comparing periodontitis patients to healthy individuals
Compare ALP level in periodontitis patients to healthy individuals
Full Information
NCT ID
NCT06048016
First Posted
September 13, 2023
Last Updated
September 19, 2023
Sponsor
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT06048016
Brief Title
Effect Of Scaling and Root Planning on ALP in Saliva and GCF In Periodontitis Patients Compared With Healthy Individuals
Official Title
Effect Of Scaling and Root Planning on Alkaline Phosphatase in Saliva and Gingival Crevicular Fluid in Periodontitis Patients Compared With Healthy Subjects Before and After Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
July 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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].
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Healthy
Keywords
ALP, Scaling, GCF, Saliva, Periodontitis, Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Group 1 : 68 Periodontitis Patients, providing scaling and root plaining . Group 2:68 healthy individuals.
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
periodontitis patients
Arm Type
Experimental
Arm Description
Periodontitis Patients participate to test level of ALP in saliva and GCF.
Intervention Type
Diagnostic Test
Intervention Name(s)
Scaling and Root Planning
Other Intervention Name(s)
gingival debridement
Intervention Description
Scaling and Root Planning by using ultrasonic scaler ,and Gracy currettes.
Primary Outcome Measure Information:
Title
Effect Of Scaling and Root Planning on Alkaline Phosphatase level in saliva and GCF
Description
Measuring ALP level in Saliva and Gingival crevicular before and after treatment
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Comparing periodontitis patients to healthy individuals
Description
Compare ALP level in periodontitis patients to healthy individuals
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
periodontitis patients stage I,II,III,IV Having more than 10 remaining teeth. • Systemically free
Exclusion Criteria:
infectious diseases dependent on antibiotics. .inflammatory diseases depend on analgesics. . Diabetes mellites patients . Hypertensive patients
.Thyroid disease
Patients who had professional periodontal treatment during the last 6 months.
Pregnancy or lactation.
Smokers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zahraa AF Nasser, Master's
Phone
01127670057
Ext
CairoU
Email
zahraa.a.nasser@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Azzahraa AR Afattah, Master's
Phone
01159866312
Ext
CairoU
Email
azzahraa.abdelrahim@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahraa Af Nasser
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zahraa Nasser
City
Giza
State/Province
Haram
ZIP/Postal Code
12944
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azzahraa Nasser
Phone
01159866312
Email
azzahraa.abdelrahim@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The participants data will include their phone numbers,photos, their signature
IPD Sharing Time Frame
1 month
IPD Sharing Access Criteria
Phone number Consent
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Effect Of Scaling and Root Planning on ALP in Saliva and GCF In Periodontitis Patients Compared With Healthy Individuals
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