PeriodontitisclinicalNCT06784869
The Efficacy of Scaling and Root Planing on Endothelin-1 Level
A study testing Scaling and root surface debritment in people with Periodontitis, run by University of Baghdad.
Trial summary
Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and root surface debritment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- systemically healthy
- Generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm)
Who cannot join
- subjects who wore dental prosthesis
- teeth with grade II mobility,
- alcoholic and smoker, had treated caries
- underwent periodontal therapy within the last four months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Scaling and Root Planing on Endothelin-1 Gingival Crevicular Fluid Levels Among Periodontitis Patients: a Randomized Clinical Trial
Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.
Aim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.
Material and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.
Read the detailed description
Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.
Aim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.
Material and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.
- Conditions
- Periodontitis
- Being tested
- Scaling and root surface debritment
- Keywords
- periodontitis, endotheiln-1, scaling and root surface debritment
- 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 surface debritmentDevice
Also called Scaling and root planing
Patients with 4-6 mm pocket depth were participated in this study; clinical periodontal parameters (BOP, PLI, PPD, CAL) were recorded at the baseline visit. To ensure sampling accuracy, From the site two papers with GCF were sampled. Following sample collecting for GCF, Every patient received comprehensive mouth supragingival scaling with an ultrasonic scaler (WoodpEEKer® UDS-K) along with dental hygiene recommendations. One week later, the sites were irrigated with normal saline after being scaled and root planed (ScRp) with Gracey curette. Following completion of subgingival instrumentation, each patient returned to the clinic following 1 and 3 months for periodontal parameter recording and GCF collection. Throughout these sessions, every patient received reinstruction to engage in self-oral hygiene practices.
| Study group | Role | What they receive |
|---|---|---|
| have generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm). | Experimental | got generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm) will undergo scaling and root surface debritment Receives: Device: Scaling and root surface debritment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPD
changes in PPD after non-surgical periodontal treatment.
Measured: 3 months recall visits
CAL
changes in CAL after non-surgical periodontal treatment.
Measured: 3 months recall visits
Secondary outcomes (1)
ET-1
change in GCF level of Endothelin-1 in 1- and 3- month following the periodontal treatment
Measured: 3 months recall visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Sep 2025 (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 University of BaghdadThe 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
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Alrihaymee, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784869
- Sponsor's protocol ID
- 1/10/2024
- Acronym
- clinical
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Scaling and Root Planing on Endothelin-1 Gingival Crevicular Fluid Levels Among Periodontitis Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06784869
- Acronym / sponsor ID
- clinical / 1/10/2024
- Conditions
- Periodontitis
- Keywords
- periodontitis, endotheiln-1, scaling and root surface debritment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Jan 2025 (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.
Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.
Aim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.
Material and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.
Detailed description
Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.
Aim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.
Material and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| have generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm). | Experimental | Device: Scaling and root surface debritmentgot generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm) will undergo scaling and root surface debritment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- systemically healthy
- Generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm)
Key exclusion criteria (4 listed)
- subjects who wore dental prosthesis
- teeth with grade II mobility,
- alcoholic and smoker, had treated caries
- underwent periodontal therapy within the last four months
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 surface debritmentAlso: Scaling and root planingPatients with 4-6 mm pocket depth were participated in this study; clinical periodontal parameters (BOP, PLI, PPD, CAL) were recorded at the baseline visit. To ensure sampling accuracy, From the site two papers with GCF were sampled. Following sample collecting for GCF, Every patient received comprehensive mouth supragingival scaling with an ultrasonic scaler (WoodpEEKer® UDS-K) along with dental hygiene recommendations. One week later, the sites were irrigated with normal saline after being scaled and root planed (ScRp) with Gracey curette. Following completion of subgingival instrumentation, each patient returned to the clinic following 1 and 3 months for periodontal parameter recording and GCF collection. Throughout these sessions, every patient received reinstruction to engage in self-oral hygiene practices. | Device | have generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm). |
Primary outcome
PPD
Time frame: 3 months recall visits
changes in PPD after non-surgical periodontal treatment.
CAL
Time frame: 3 months recall visits
changes in CAL after non-surgical periodontal treatment.
1 secondary outcome
ET-1
Time frame: 3 months recall visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root surface debritment in people with Periodontitis, run by University of Baghdad.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah alrihaymee (07828802375, sarra.anwar1205a@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPD (time frame: 3 months recall visits). The study lists 2 primary outcomes in all. 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 20 Jan 2025.