Effect Of Scaling and Root Planning on ALP in Saliva and GCF In Periodontitis Patients Compared With Healthy Individuals

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06048016
Collaborator
(none)
134
1
1
12.8
10.4

Study Details

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].

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Scaling and Root Planning
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Group 1 : 68 Periodontitis Patients, providing scaling and root plaining . Group 2:68 healthy individuals.Group 1 : 68 Periodontitis Patients, providing scaling and root plaining . Group 2:68 healthy individuals.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Jul 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: periodontitis patients

Periodontitis Patients participate to test level of ALP in saliva and GCF.

Diagnostic Test: Scaling and Root Planning
Scaling and Root Planning by using ultrasonic scaler ,and Gracy currettes.
Other Names:
  • gingival debridement
  • Outcome Measures

    Primary Outcome Measures

    1. Effect Of Scaling and Root Planning on Alkaline Phosphatase level in saliva and GCF [1 month]

      Measuring ALP level in Saliva and Gingival crevicular before and after treatment

    Secondary Outcome Measures

    1. Comparing periodontitis patients to healthy individuals [1 month]

      Compare ALP level in periodontitis patients to healthy individuals

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zahraa Nasser Giza Haram Egypt 12944

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Zahraa Af Nasser, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Azzahraa Abdel Fattah Abdelrahim, Principle investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT06048016
    Other Study ID Numbers:
    • PER7_2_1
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Azzahraa Abdel Fattah Abdelrahim, Principle investigator, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2023