NCT06048016

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 \[AlkalinePhosphatase level\].

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

September 13, 2023

Last Update Submit

September 19, 2023

Conditions

Keywords

ALPScalingGCFSalivaPeriodontitisHealth

Outcome Measures

Primary Outcomes (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

    1 month

Secondary Outcomes (1)

  • Comparing periodontitis patients to healthy individuals

    1 month

Study Arms (1)

periodontitis patients

EXPERIMENTAL

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

Diagnostic Test: Scaling and Root Planning

Interventions

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

Also known as: gingival debridement
periodontitis patients

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zahraa Nasser

Giza, Haram, 12944, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Zahraa Af Nasser

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahraa AF Nasser, Master's

CONTACT

Azzahraa AR Afattah, Master's

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Group 1 : 68 Periodontitis Patients, providing scaling and root plaining . Group 2:68 healthy individuals.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

June 15, 2023

Primary Completion

December 30, 2023

Study Completion

July 10, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

The participants data will include their phone numbers,photos, their signature

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
1 month
Access Criteria
Phone number Consent

Locations