An observational study in Oral Potentially Malignant Disorders, Oral Lichen Planus and Oral Leukoplakia, sponsored by British University In Egypt. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by British University In Egypt · Observational
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:
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.
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.
145 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
This study's planned enrollment of 250 is above the median of 78 across 39 observational studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →British University In Egypt is the lead sponsor of 70 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All participants:
Healthy controls:
OPMD group:
OSCC group (exploratory):
Exclusion Criteria:
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.
Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement
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.
Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement
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.
Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement
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.
Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement
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.
Diagnostic Test: Salivary IL-8 and Serum IL-6 Measurement
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.
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.
Time frame: 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.
Time frame: At enrollment (single visit, before any definitive lesion treatment)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At enrollment (single visit)
Exploratory: Discrimination of OSCC Versus Current-Smoking OPMD by Salivary IL-8 and Serum IL-6
AUC with 95% bootstrap confidence intervals for IL-8, IL-6 and their combination in discriminating current-smoking patients with oral squamous cell carcinoma from current-smoking patients with OPMDs.
Time frame: At enrollment (single visit)
Exploratory: Cross-Validated Performance of Biomarker-Based Prediction Models for OPMD
AUC and Brier score (with sensitivity, specificity and accuracy where reported) of logistic-regression models 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. Internal validation only.
Time frame: At enrollment (single visit)
Started Oct 2026 (actual). Primary completion is estimated for Dec 2026, 2 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
British University In Egypt