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.
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
- Recruiting
Zahraa Nasser
Giza, Haram, 12944
Azzahraa Nasser, 01159866312, azzahraa.abdelrahim@dentistry.cu.edu.eg
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).
- Conditions
- Periodontitis, Healthy
- 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 group | Role | What they receive |
|---|---|---|
| periodontitis patients | Experimental | Periodontitis 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.
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)
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.
- First posted21 Sep 2023
- Study start15 Jun 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azzahraa Abdel Fattah Abdelrahim, Cairo University
- Investigators
- Zahraa Af Nasser, Principal investigator, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06048016
- Acronym / sponsor ID
- PER7_2_1
- Conditions
- Periodontitis, Healthy
- Keywords
- ALP, Scaling, GCF, Saliva, Periodontitis, Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Group 1 : 68 Periodontitis Patients, providing scaling and root plaining . Group 2:68 healthy individuals.
| Arm | Type | Receives |
|---|---|---|
| periodontitis patients | Experimental | Diagnostic Test: Scaling and Root PlanningPeriodontitis Patients participate to test level of ALP in saliva and GCF. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- periodontitis patients stage I,II,III,IV Having more than 10 remaining teeth. • Systemically free
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and Root PlanningAlso: gingival debridementScaling and Root Planning by using ultrasonic scaler ,and Gracy currettes. | Diagnostic test | periodontitis patients |
Primary outcome
Effect Of Scaling and Root Planning on Alkaline Phosphatase level in saliva and GCF
Time frame: 1 month
Measuring ALP level in Saliva and Gingival crevicular before and after treatment
1 secondary outcome
Comparing periodontitis patients to healthy individuals
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Yes. The participants data will include their phone numbers,photos, their signature
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahraa Af Nasser principal investigator
Cairo University
1 site in 1 country: see every site and its status.
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.