Peridontal DiseaseNCT06789458
Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy
A study of Peridontal Disease, run by Cairo University at 2 sites in Egypt.
Trial summary
This study aims to assess Pro-Resolution Mediator levels during non-surgical periodontal therapy in individuals with Stage III and IV periodontitis, comparing them to healthy subjects. Periodontitis, a chronic inflammatory condition affecting tooth-supporting tissues, can lead to tooth loss and systemic complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peridontal Disease
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Oct 2022to 14 Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients above 18 years old.
- Interdental CAL at site of greatest loss ≥5 mm or extending to middle third of the root.
- Interdental CAL at site of greatest loss ≥8 mm or extending to apical third of the root.
- Probing depth ≥6 mm.
- Vertical bone loss ≥3 mm.
- Tooth loss due to periodontitis of ≤4 teeth. (Periodontitis Stage III)
Show all 14Show fewer
- Tooth loss due to periodontitis of ≥5 teeth. (Periodontitis Stage IV)
- Furcation involvement Class II or III Moderate ridge defect.
- -
- Systemically healthy patients.
- Patients with an age range between 16 to 80 years.
- Patients have a minimum of 20 teeth.
- Less than 10% bleeding sites with probing depths ≤3 mm.
- absence of erythema, oedema.
Who cannot join
- 1. Pregnancy or lactation. 2. Smoking more than 20 cigarettes. 3. Immuno-inflammatory conditions of the skin and oral mucosa 4. systemic conditions affecting bone turnover and periodontal health status (e.g. endocrine and connective tissue diseases, bisphosphonate antiresorptive therapy, gastrointestinal diseases related to nutrition and mineral metabolism) 5. Periodontal or orthodontic treatment at least 6 months before the start of the study 6. Use of anti-inflammatory and antimicrobial agents within 3 months before sampling
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
faculty of dentistry Cairo university
Cairo
Husam Ghazi alharbi, 0223642705, husam.ghazi@dentistry.cu.edu.eg
- Recruiting
Faculty of Dentistry-Cairo University
Manial, Cairo Governorate, 12311
About this study
This study aims to assess Pro-Resolution Mediator levels during non-surgical periodontal therapy in individuals with Stage III and IV periodontitis, comparing them to healthy subjects. Periodontitis, a chronic inflammatory condition affecting tooth-supporting tissues, can lead to tooth loss and systemic complications. Understanding the role of pro-resolving lipid mediators in inflammation resolution may offer insights into therapeutic benefits associated with these mediators.
Read the detailed description
Periodontitis is a chronic inflammatory disease that affects the tooth-supporting tissues, it produces a slow destruction of the periodontium that may eventually result in tooth loss. Periodontitis is caused by a dysbiosis of the immune system where there is an imbalance between the processes that activate and terminate the inflammatory process.(Van Dyke, 2020) Pro-resolving lipid mediators (PMs) play a key role in actively resolving inflammation, modulating immune responses, and promoting tissue healing. However, the understanding of PMs in periodontitis and their role in the enduring nature of the disease has not been sufficiently studied in a clinical setting. It has been suggested that PM levels vary between periodontitis patients and healthy individual with periodontal therapy potentially restoring the balance between pro- and anti-inflammatory mediators. (Van Dyke, 2017) The study aims to provide insights into inflammation resolution mechanisms in periodontitis and the therapeutic potential of PMs.
This study aims to Assess Pro-Resolution Mediator Levels During Periodontal Therapy in Patients with Periodontitis Stage III and IV compared to healthy patients.
Hypothesis Null Hypothesis: pro-resolution mediators' level before and after non-surgical treatment in stage III and IV periodontitis compared to healthy patients, there will be no difference in level before and after non-surgical treatment between stage III and IV periodontitis compared to healthy patients.
Trial design:
The current study design is a before and after trial with a single (interventional) population measured before and after treatment compared to a negative control of healthy patients.
- Conditions
- Peridontal Disease
- Being tested
- Professional mechanical plaque control
- Keywords
- lipoxin, proresolution mediators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional mechanical plaque controlProcedure or surgery
thisThe first step in therapy is aimed at guiding behavior change by motivating the patient to undertake successful removal of supragingival dental biofilm and risk factor control and may include the following interventions:
- Interventions to improve the effectiveness of oral hygiene [motivation, instructions (oral hygiene instructions, OHI)
- Professional mechanical plaque removal (PMPR), which includes the professional interventions aimed at removing supragingival plaque and calculus, as well as possible plaque-retentive factors that impair oral hygiene practices.
- Adjustment of faulty restoration and polishing
- The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | No intervention | Systemically healthy patient |
| Periodontitis Stage III and IV | Active comparator | Professional mechanical plaque control Receives: Procedure: Professional mechanical plaque control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of GCF lipoxin A4
Measured: preoperative, one day, one month and 3 months postoperative
Secondary outcomes (6)
Change in level of GCF Protectin
Measured: preoperative, one day, one month and 3 months postoperative
Probing pocket depth (PPD)
Measured: preoperative, and 3 months postoperative
Bleeding On Probing (BOP)
Measured: preoperative, and 3 months postoperative
Plaque index (PI)
Measured: preoperative, and 3 months postoperative
Clinical Attachment Level (CAL)
Measured: preoperative, and 3 months postoperative
Number of pockets closed
Measured: preoperative, and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start15 Oct 2022
- Primary completion14 Oct 2025 (estimated)
- Study completion14 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peridontal DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Husam Ghazi Dwerj Alharbi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789458
- Sponsor's protocol ID
- 20042024PER7_2_2
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy
- ClinicalTrials.gov ID
- NCT06789458
- Acronym / sponsor ID
- 20042024PER7_2_2
- Conditions
- Peridontal Disease
- Keywords
- lipoxin, proresolution mediators
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 14 Oct 2025 (estimated)
- Study completion
- 14 Oct 2025 (estimated)
- First posted
- 23 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.
This study aims to assess Pro-Resolution Mediator levels during non-surgical periodontal therapy in individuals with Stage III and IV periodontitis, comparing them to healthy subjects. Periodontitis, a chronic inflammatory condition affecting tooth-supporting tissues, can lead to tooth loss and systemic complications. Understanding the role of pro-resolving lipid mediators in inflammation resolution may offer insights into therapeutic benefits associated with these mediators.
Detailed description
Periodontitis is a chronic inflammatory disease that affects the tooth-supporting tissues, it produces a slow destruction of the periodontium that may eventually result in tooth loss. Periodontitis is caused by a dysbiosis of the immune system where there is an imbalance between the processes that activate and terminate the inflammatory process.(Van Dyke, 2020) Pro-resolving lipid mediators (PMs) play a key role in actively resolving inflammation, modulating immune responses, and promoting tissue healing. However, the understanding of PMs in periodontitis and their role in the enduring nature of the disease has not been sufficiently studied in a clinical setting. It has been suggested that PM levels vary between periodontitis patients and healthy individual with periodontal therapy potentially restoring the balance between pro- and anti-inflammatory mediators. (Van Dyke, 2017) The study aims to provide insights into inflammation resolution mechanisms in periodontitis and the therapeutic potential of PMs.
This study aims to Assess Pro-Resolution Mediator Levels During Periodontal Therapy in Patients with Periodontitis Stage III and IV compared to healthy patients.
Hypothesis Null Hypothesis: pro-resolution mediators' level before and after non-surgical treatment in stage III and IV periodontitis compared to healthy patients, there will be no difference in level before and after non-surgical treatment between stage III and IV periodontitis compared to healthy patients.
Trial design:
The current study design is a before and after trial with a single (interventional) population measured before and after treatment compared to a negative control of healthy patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | No intervention | –Systemically healthy patient |
| Periodontitis Stage III and IV | Active comparator | Procedure: Professional mechanical plaque controlProfessional mechanical plaque control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult patients above 18 years old.
- Interdental CAL at site of greatest loss ≥5 mm or extending to middle third of the root.
- Interdental CAL at site of greatest loss ≥8 mm or extending to apical third of the root.
- Probing depth ≥6 mm.
- Vertical bone loss ≥3 mm.
Key exclusion criteria (1 listed)
- 1. Pregnancy or lactation. 2. Smoking more than 20 cigarettes. 3. Immuno-inflammatory conditions of the skin and oral mucosa 4. systemic conditions affecting bone turnover and periodontal health status (e.g. endocrine and connective tissue diseases, bisphosphonate antiresorptive therapy, gastrointestinal diseases related to nutrition and mineral metabolism) 5. Periodontal or orthodontic treatment at least 6 months before the start of the study 6. Use of anti-inflammatory and antimicrobial agents within 3 months before sampling
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 |
|---|---|---|
| Professional mechanical plaque controlthisThe first step in therapy is aimed at guiding behavior change by motivating the patient to undertake successful removal of supragingival dental biofilm and risk factor control and may include the following interventions: * Interventions to improve the effectiveness of oral hygiene [motivation, instructions (oral hygiene instructions, OHI) * Professional mechanical plaque removal (PMPR), which includes the professional interventions aimed at removing supragingival plaque and calculus, as well as possible plaque-retentive factors that impair oral hygiene practices. * Adjustment of faulty restoration and polishing * The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. | Procedure or surgery | Periodontitis Stage III and IV |
Primary outcome
Change in level of GCF lipoxin A4
Time frame: preoperative, one day, one month and 3 months postoperative
6 secondary outcomes
Change in level of GCF Protectin
Time frame: preoperative, one day, one month and 3 months postoperative
Probing pocket depth (PPD)
Time frame: preoperative, and 3 months postoperative
Bleeding On Probing (BOP)
Time frame: preoperative, and 3 months postoperative
Plaque index (PI)
Time frame: preoperative, and 3 months postoperative
Clinical Attachment Level (CAL)
Time frame: preoperative, and 3 months postoperative
Number of pockets closed
Time frame: preoperative, and 3 months postoperative
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 23 Jan 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Peridontal Disease, run by Cairo University at 2 sites 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 14 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Husam Ghazi Alharbi, Master Degree (+201222284055 ext. +20, husam.ghazi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of GCF lipoxin A4 (time frame: preoperative, one day, one month and 3 months postoperative). 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 23 Jan 2025.