Oral Potentially Malignant DisordersNCT07915570
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
An observational study of Oral Potentially Malignant Disorders and Oral Lichen Planus, run by British University In Egypt at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn whether two inflammatory proteins, interleukin-8 (IL-8) measured in saliva and interleukin-6 (IL-6) measured in blood serum, can help distinguish adults with oral potentially malignant disorders (OPMDs), such as oral lichen planus and leukoplakia, from adults with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Potentially Malignant Disorders, Oral Lichen Planus, Oral Leukoplakia
- What is being tested?
- Salivary IL-8 and Serum IL-6 Measurement
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 30 Jan 2027
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults attending the study center for oral examination or for evaluation of oral mucosal lesions: clinically healthy volunteers (never-smokers and current smokers), patients with histopathologically confirmed oral potentially malignant disorders (oral lichen planus or oral leukoplakia; never-smokers and current smokers), and current-smoking patients with histopathologically confirmed oral squamous cell carcinoma.
Who may be able to join
- All participants:
- Age 18 years or older
- Written informed consent provided before enrollment
- Smoking status classifiable as never-smoker or current smoker
- Healthy controls:
- Clinically healthy oral mucosa
Show all 13Show fewer
- No clinical evidence or previous history of oral potentially malignant disorders (OPMDs) or oral cancer
- OPMD group:
- Clinically identified oral lichen planus or oral leukoplakia, confirmed histopathologically
- No definitive treatment of the lesion before biological-sample collection
- OSCC group (exploratory):
- Histopathologically confirmed oral squamous cell carcinoma
- Current smoker
Who cannot join
- Active oral infection unrelated to the study lesion
- Recent major dental surgery or invasive dental procedure
- Active or recent systemic infection
- Uncontrolled diabetes mellitus
- Major systemic inflammatory or autoimmune disease
- Clinically significant salivary gland dysfunction
Show all 9Show fewer
- Current systemic treatment likely to substantially affect inflammatory cytokine concentrations (e.g., systemic corticosteroids or immunomodulatory agents)
- Essential clinical data or smoking-status classification unavailable
- Biological samples insufficient, unsuitable for analysis, or failing predefined laboratory quality-control criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
The British University in Egypt
Cairo, 112344
Ahmed Hassan, Professoe, +20 10 05120159, ahmed.hasan@bue.edu.eg
About this study
Official title: Diagnostic Performance of Salivary Interleukin-8 and Serum Interleukin-6 for Oral Potentially Malignant Disorders: Effect Modification by Smoking Status - A Cross-Sectional Study
The goal of this observational study is to learn whether two inflammatory proteins, interleukin-8 (IL-8) measured in saliva and interleukin-6 (IL-6) measured in blood serum, can help distinguish adults with oral potentially malignant disorders (OPMDs), such as oral lichen planus and leukoplakia, from adults with healthy oral mucosa, and whether smoking changes these protein levels.
The main questions it aims to answer are:
Read more
- Do salivary IL-8 and serum IL-6 levels differ between people with OPMDs and healthy controls, and does this difference depend on smoking status?
- How well do IL-8 and IL-6, alone or combined, discriminate people with OPMDs from healthy controls?
Researchers compared healthy never-smokers, healthy current smokers, never-smokers with OPMDs, and current smokers with OPMDs. An additional exploratory group of current smokers with oral squamous cell carcinoma (OSCC) was compared with current smokers with OPMDs.
Participants provided an unstimulated whole saliva sample and a blood sample at a single visit, and completed a clinical, periodontal, and tobacco-use assessment. No treatment was assigned as part of the study.
Read the detailed description
Design: Cross-sectional observational diagnostic study, reported with reference to the STROBE guidelines.
Population: 250 adults (18 years or older). The primary cohort comprised 200 participants in four equal groups (n = 50 each): healthy never-smokers, healthy current smokers, never-smokers with histopathologically confirmed OPMDs, and current smokers with histopathologically confirmed OPMDs. OPMDs included oral lichen planus and oral leukoplakia; lesion subtype, anatomical site, and presence and grade of epithelial dysplasia were recorded. An exploratory cohort of 50 current smokers with histopathologically confirmed oral squamous cell carcinoma (OSCC) was analyzed separately and was not part of the primary comparisons.
Assessments: Smoking status (never vs. current) and tobacco exposure (daily cigarette consumption, smoking duration, shisha use, electronic-cigarette use, dual-tobacco use); demographic data; plaque index, percentage of sites with bleeding on probing, and periodontal status (healthy, gingivitis, periodontitis); histopathological classification (dysplasia for OPMDs, tumor grade for OSCC).
Biomarkers: Unstimulated whole saliva was collected for IL-8 and serum for IL-6. Concentrations were measured by immunoassay and expressed in pg/mL.
Statistical analysis: Group comparisons used t-tests or Mann-Whitney U tests and chi-square or Fisher's exact tests. Linear regression models of log-transformed IL-8 and IL-6 included disease status, smoking status, and their interaction, with HC3 robust standard errors. Logistic regression evaluated each biomarker individually and jointly, with adjustment for age, sex, and smoking, and an exploratory model adding periodontal variables. ROC analysis estimated AUCs with 95% bootstrap confidence intervals; sensitivity and specificity were calculated at Youden-index thresholds. Exploratory prediction models (logistic regression) were evaluated with repeated stratified five-fold cross-validation (20 repetitions), comparing four predictor sets: IL-8; IL-8 + IL-6; both biomarkers + smoking status; and these plus demographic and periodontal variables.
Sample size: With 100 OPMD patients and 100 controls, two-sided alpha = 0.05 and 80% power, the minimum detectable difference was approximately 0.40 SD, and the minimum detectable AUC against 0.50 was approximately 0.61.
- Conditions
- Oral Potentially Malignant Disorders, Oral Lichen Planus, Oral Leukoplakia, Oral Squamous Cell Carcinoma, Smoking
- Being tested
- Salivary IL-8 and Serum IL-6 Measurement
- Keywords
- Interleukin-8, Interleukin-6, Salivary Biomarkers, Diagnostic Accuracy, Tobacco Use, Periodontal Status
- Medical subject headings
- Lichen Planus, Oral, Leukoplakia, Oral, Squamous Cell Carcinoma of Head and Neck, Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary IL-8 and Serum IL-6 MeasurementDiagnostic test
No treatment is assigned. All participants provide a single unstimulated whole saliva sample, analyzed for interleukin-8 (IL-8), and a blood sample, from which serum is analyzed for interleukin-6 (IL-6). Concentrations are measured by immunoassay and expressed in pg/mL. Biomarker levels are compared between groups and evaluated, individually and combined, for diagnostic discrimination.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls - Never-Smokers | Adults with clinically healthy oral mucosa and no current or previous oral potentially malignant disorder or oral cancer, who have never smoked (n = 50). Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, periodontal and tobacco-use assessment. Receives: Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement | |
| Healthy Controls - Current Smokers | Adults with clinically healthy oral mucosa and no current or previous oral potentially malignant disorder or oral cancer, who are current smokers (n = 50). Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, periodontal and tobacco-use assessment. Receives: Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement | |
| OPMD - Never-Smokers | Adults who have never smoked, with a histopathologically confirmed oral potentially malignant disorder (oral lichen planus or oral leukoplakia) and no definitive treatment of the lesion before sample collection (n = 50). Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, histopathological, periodontal and tobacco-use assessment. Receives: Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement | |
| OPMD - Current Smokers | Adults who are current smokers, with a histopathologically confirmed oral potentially malignant disorder (oral lichen planus or oral leukoplakia) and no definitive treatment of the lesion before sample collection (n = 50). Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, histopathological, periodontal and tobacco-use assessment. Receives: Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement | |
| OSCC - Current Smokers (Exploratory) | Adults who are current smokers, with histopathologically confirmed oral squamous cell carcinoma (n = 50). Exploratory cohort compared with current-smoking OPMD patients; not included in the primary healthy control versus OPMD comparisons. Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, histopathological (tumor grade), periodontal and tobacco-use assessment. Receives: Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary IL-8 Concentration
Salivary interleukin-8 (IL-8) concentration, measured using an enzyme-linked immunosorbent assay (ELISA) and expressed in pg/mL. Concentrations are compared between healthy controls and participants with oral potentially malignant disorders (OPMDs), with analyses stratified by smoking status where applicable.
Measured: At enrollment (single visit, before any definitive lesion treatment)
Serum IL-6 Concentration
Serum interleukin-6 (IL-6) concentration, measured using an ELISA and expressed in pg/mL. Concentrations are compared between healthy controls and participants with OPMDs, with analyses stratified by smoking status where applicable.
Measured: At enrollment (single visit, before any definitive lesion treatment)
Secondary outcomes (4)
Diagnostic Discrimination (AUC) of Salivary IL-8, Serum IL-6 and Their Combination for OPMD Versus Healthy Controls
Area under the receiver operating characteristic curve (AUC) with 95% bootstrap confidence intervals for IL-8 alone, IL-6 alone and both combined, overall and stratified by smoking status (stratified analyses descriptive).
Measured: At enrollment (single visit)
Sensitivity and Specificity of Salivary IL-8 and Serum IL-6 for OPMD Versus Healthy Controls
Sensitivity and specificity (%) of each biomarker and their combination at cut-off values selected using Youden's index.
Measured: At enrollment (single visit)
Salivary IL-8 and Serum IL-6 Concentrations by OPMD Subtype and Dysplasia Status
Biomarker concentrations (pg/mL) compared between oral lichen planus and oral leukoplakia, and between OPMD lesions with and without histopathological epithelial dysplasia.
Measured: At enrollment (single visit)
Correlation Between Salivary IL-8 and Serum IL-6 Concentrations
The correlation between salivary IL-8 concentration (pg/mL) and serum IL-6 concentration (pg/mL), both measured using ELISA, is assessed using Pearson's correlation coefficient (r), with Spearman's rank correlation coefficient (ρ) used as a complementary measure.
Measured: At enrollment (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Oct 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Potentially Malignant DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915570
- Sponsor's protocol ID
- BU121267
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Salivary Interleukin-8 and Serum Interleukin-6 for Oral Potentially Malignant Disorders: Effect Modification by Smoking Status - A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07915570
- Acronym / sponsor ID
- BU121267
- Conditions
- Oral Potentially Malignant Disorders, Oral Lichen Planus, Oral Leukoplakia, Oral Squamous Cell Carcinoma, Smoking
- Keywords
- Interleukin-8, Interleukin-6, Salivary Biomarkers, Diagnostic Accuracy, Tobacco Use, Periodontal Status
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 4 Nov 2026 (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 observational study is to learn whether two inflammatory proteins, interleukin-8 (IL-8) measured in saliva and interleukin-6 (IL-6) measured in blood serum, can help distinguish adults with oral potentially malignant disorders (OPMDs), such as oral lichen planus and leukoplakia, from adults with healthy oral mucosa, and whether smoking changes these protein levels.
The main questions it aims to answer are:
- Do salivary IL-8 and serum IL-6 levels differ between people with OPMDs and healthy controls, and does this difference depend on smoking status?
- How well do IL-8 and IL-6, alone or combined, discriminate people with OPMDs from healthy controls?
Researchers compared healthy never-smokers, healthy current smokers, never-smokers with OPMDs, and current smokers with OPMDs. An additional exploratory group of current smokers with oral squamous cell carcinoma (OSCC) was compared with current smokers with OPMDs.
Participants provided an unstimulated whole saliva sample and a blood sample at a single visit, and completed a clinical, periodontal, and tobacco-use assessment. No treatment was assigned as part of the study.
Detailed description
Design: Cross-sectional observational diagnostic study, reported with reference to the STROBE guidelines.
Population: 250 adults (18 years or older). The primary cohort comprised 200 participants in four equal groups (n = 50 each): healthy never-smokers, healthy current smokers, never-smokers with histopathologically confirmed OPMDs, and current smokers with histopathologically confirmed OPMDs. OPMDs included oral lichen planus and oral leukoplakia; lesion subtype, anatomical site, and presence and grade of epithelial dysplasia were recorded. An exploratory cohort of 50 current smokers with histopathologically confirmed oral squamous cell carcinoma (OSCC) was analyzed separately and was not part of the primary comparisons.
Assessments: Smoking status (never vs. current) and tobacco exposure (daily cigarette consumption, smoking duration, shisha use, electronic-cigarette use, dual-tobacco use); demographic data; plaque index, percentage of sites with bleeding on probing, and periodontal status (healthy, gingivitis, periodontitis); histopathological classification (dysplasia for OPMDs, tumor grade for OSCC).
Biomarkers: Unstimulated whole saliva was collected for IL-8 and serum for IL-6. Concentrations were measured by immunoassay and expressed in pg/mL.
Statistical analysis: Group comparisons used t-tests or Mann-Whitney U tests and chi-square or Fisher's exact tests. Linear regression models of log-transformed IL-8 and IL-6 included disease status, smoking status, and their interaction, with HC3 robust standard errors. Logistic regression evaluated each biomarker individually and jointly, with adjustment for age, sex, and smoking, and an exploratory model adding periodontal variables. ROC analysis estimated AUCs with 95% bootstrap confidence intervals; sensitivity and specificity were calculated at Youden-index thresholds. Exploratory prediction models (logistic regression) were evaluated with repeated stratified five-fold cross-validation (20 repetitions), comparing four predictor sets: IL-8; IL-8 + IL-6; both biomarkers + smoking status; and these plus demographic and periodontal variables.
Sample size: With 100 OPMD patients and 100 controls, two-sided alpha = 0.05 and 80% power, the minimum detectable difference was approximately 0.40 SD, and the minimum detectable AUC against 0.50 was approximately 0.61.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls - Never-Smokers | – | Diagnostic Test: Salivary IL-8 and Serum IL-6 MeasurementAdults with clinically healthy oral mucosa and no current or previous oral potentially malignant disorder or oral cancer, who have never smoked (n = 50). Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, periodontal and tobacco-use assessment. |
| Healthy Controls - Current Smokers | – | Diagnostic Test: Salivary IL-8 and Serum IL-6 MeasurementAdults with clinically healthy oral mucosa and no current or previous oral potentially malignant disorder or oral cancer, who are current smokers (n = 50). Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, periodontal and tobacco-use assessment. |
| OPMD - Never-Smokers | – | Diagnostic Test: Salivary IL-8 and Serum IL-6 MeasurementAdults who have never smoked, with a histopathologically confirmed oral potentially malignant disorder (oral lichen planus or oral leukoplakia) and no definitive treatment of the lesion before sample collection (n = 50). Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, histopathological, periodontal and tobacco-use assessment. |
| OPMD - Current Smokers | – | Diagnostic Test: Salivary IL-8 and Serum IL-6 MeasurementAdults who are current smokers, with a histopathologically confirmed oral potentially malignant disorder (oral lichen planus or oral leukoplakia) and no definitive treatment of the lesion before sample collection (n = 50). Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, histopathological, periodontal and tobacco-use assessment. |
| OSCC - Current Smokers (Exploratory) | – | Diagnostic Test: Salivary IL-8 and Serum IL-6 MeasurementAdults who are current smokers, with histopathologically confirmed oral squamous cell carcinoma (n = 50). Exploratory cohort compared with current-smoking OPMD patients; not included in the primary healthy control versus OPMD comparisons. Single-visit collection of unstimulated whole saliva (IL-8) and serum (IL-6), with clinical, histopathological (tumor grade), periodontal and tobacco-use assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults attending the study center for oral examination or for evaluation of oral mucosal lesions: clinically healthy volunteers (never-smokers and current smokers), patients with histopathologically confirmed oral potentially malignant disorders (oral lichen planus or oral leukoplakia; never-smokers and current smokers), and current-smoking patients with histopathologically confirmed oral squamous cell carcinoma.
Key inclusion criteria (13 listed)
- Age 18 years or older
- Written informed consent provided before enrollment
- Smoking status classifiable as never-smoker or current smoker
- Clinically healthy oral mucosa
- No clinical evidence or previous history of oral potentially malignant disorders (OPMDs) or oral cancer
Key exclusion criteria (9 listed)
- Active oral infection unrelated to the study lesion
- Recent major dental surgery or invasive dental procedure
- Active or recent systemic infection
- Uncontrolled diabetes mellitus
- Major systemic inflammatory or autoimmune disease
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 |
|---|---|---|
| Salivary IL-8 and Serum IL-6 MeasurementNo treatment is assigned. All participants provide a single unstimulated whole saliva sample, analyzed for interleukin-8 (IL-8), and a blood sample, from which serum is analyzed for interleukin-6 (IL-6). Concentrations are measured by immunoassay and expressed in pg/mL. Biomarker levels are compared between groups and evaluated, individually and combined, for diagnostic discrimination. | Diagnostic test | Healthy Controls - Current Smokers, Healthy Controls - Never-Smokers, OPMD - Current Smokers, OPMD - Never-Smokers, OSCC - Current Smokers (Exploratory) |
Primary outcome
Salivary IL-8 Concentration
Time frame: At enrollment (single visit, before any definitive lesion treatment)
Salivary interleukin-8 (IL-8) concentration, measured using an enzyme-linked immunosorbent assay (ELISA) and expressed in pg/mL. Concentrations are compared between healthy controls and participants with oral potentially malignant disorders (OPMDs), with analyses stratified by smoking status where applicable.
Serum IL-6 Concentration
Time frame: At enrollment (single visit, before any definitive lesion treatment)
Serum interleukin-6 (IL-6) concentration, measured using an ELISA and expressed in pg/mL. Concentrations are compared between healthy controls and participants with OPMDs, with analyses stratified by smoking status where applicable.
4 secondary outcomes
Diagnostic Discrimination (AUC) of Salivary IL-8, Serum IL-6 and Their Combination for OPMD Versus Healthy Controls
Time frame: At enrollment (single visit)
Sensitivity and Specificity of Salivary IL-8 and Serum IL-6 for OPMD Versus Healthy Controls
Time frame: At enrollment (single visit)
Salivary IL-8 and Serum IL-6 Concentrations by OPMD Subtype and Dysplasia Status
Time frame: At enrollment (single visit)
Correlation Between Salivary IL-8 and Serum IL-6 Concentrations
Time frame: At enrollment (single visit)
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 4 Nov 2026.
Related trials for Oral Potentially Malignant Disorders
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Active, not recruitingEarly Phase 1
Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
Dysplasia, Lip and Oral Cavity Carcinoma
Not yet recruiting
Feasibility and Validation of an Automated AI-Enabled Deep Ultraviolet (DUV) Cytology Platform for Point-of-Care Oral Cancer Triage
Oral Potentially Malignant Lesions, Oral Potentially Malignant Disorders
Enrolling by invitation
The Importance of Mucosal Screening in the Prevention of Oral Cancer.
OPMD, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
RecruitingObservational study
The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study
Smoking, Smoking, Cigarette
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Potentially Malignant Disorders and Oral Lichen Planus, run by British University In Egypt 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 13 inclusion and 9 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 4 Nov 2026. 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?
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 Dalia Ghalwash, professor (+20 10 05120159, dalia.ghalwash@bue.edu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary IL-8 Concentration (time frame: At enrollment (single visit, before any definitive lesion treatment)). 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 4 Nov 2026.