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PeriodontitisNCT06048016

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

A study testing Scaling and Root Planning in people with Periodontitis and Healthy, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 15 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis, Healthy
What is being tested?
Scaling and Root Planning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteEgypt
Study dates
15 Jun 2023to 10 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • periodontitis patients stage I,II,III,IV Having more than 10 remaining teeth. • Systemically free

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Zahraa Nasser

    Giza, Haram, 12944

    Azzahraa Nasser, 01159866312, azzahraa.abdelrahim@dentistry.cu.edu.eg

    Recruiting

Other trials in Egypt

About this study

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

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].

Read the 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).

Being tested
Scaling and Root Planning
Keywords
ALP, Scaling, GCF, Saliva, Periodontitis, Health
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scaling and Root PlanningDiagnostic test

    Also called gingival debridement

    Scaling and Root Planning by using ultrasonic scaler ,and Gracy currettes.

Study groups in NCT06048016
Study groupRoleWhat they receive
periodontitis patientsExperimentalPeriodontitis Patients participate to test level of ALP in saliva and GCF.
Receives: Diagnostic Test: Scaling and Root Planning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month

Secondary outcomes (1)
  1. Comparing periodontitis patients to healthy individuals

    Compare ALP level in periodontitis patients to healthy individuals

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start15 Jun 2023
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion10 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Group 1 : 68 Periodontitis Patients, providing scaling and root plaining . Group 2:68 healthy individuals.
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06048016
Sponsor's protocol ID
PER7_2_1
Status last verified
Sep 2023
First submitted
13 Sep 2023
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The participants data will include their phone numbers,photos, their signature

Questions about this trial

What is this clinical trial studying?

A study testing Scaling and Root Planning in people with Periodontitis and Healthy, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zahraa AF Nasser, Master's (01127670057 ext. CairoU, zahraa.a.nasser@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect Of Scaling and Root Planning on Alkaline Phosphatase level in saliva and GCF (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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