Effect of Non-Surgical Periodontal Therapy on Salivary Biomarkers in Smokers and Non-Smokers With Periodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAl-Mustansiriyah University
About this trial
This study evaluates the effect of non-surgical periodontal therapy on salivary biomarkers (Dkk-1, Sclerostin, and PLAP-1) and clinical periodontal parameters in patients with periodontitis. Periodontitis is a chronic inflammatory disease that destroys tooth-supporting tissues. Smoking is a significant risk factor that worsens periodontal destruction and reduces the effectiveness of standard therapies.
* The trial is a non-randomized comparative clinical study. * It includes 44 adult patients diagnosed with Stage II and III periodontitis. * The participants are divided into two equal groups: 22 current smokers and 22 non-smokers. * Participants will undergo a baseline examination, followed by standardized non-surgical periodontal therapy consisting of scaling and root planing. * A follow-up visit will be conducted six weeks post-therapy to repeat clinical measurements and saliva collection. * The primary objective is to evaluate changes in salivary biomarker levels and clinical parameters (Plaque Index, Gingival Index, bleeding on probing, Probing Pocket Depth, Clinical Attachment Level) after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Systemically healthy.
Diagnosed with Stage II and III periodontitis.
Presence of ≥ 20 teeth (excluding third molars).
Current smoker OR non-smoker
Disqualifiers
Presence of systemic diseases affecting the periodontium.
Use of medications affecting inflammation.
Received periodontal therapy in the past 6 months.
Received antibiotic therapy in the last 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Non-surgical periodontal therapy (Scaling and root planing)
Procedure/SurgeryStandardized non-surgical periodontal therapy performed over two visits (scaling at the first visit and root planing after one week).
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: SmokersActive comparator 1 intervention
Group B: Non-smokersActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Salivary Dickkopf-1 (Dkk-1) Levels
Salivary Dkk-1 levels will be quantified using a specific human Enzyme-Linked Immunosorbent Assay (ELISA) kit.
Time frame
Baseline and 6 weeks post-therapy.2
Change in Salivary Sclerostin (SOST) Levels
Salivary Sclerostin (SOST) levels will be quantified using a specific human Enzyme-Linked Immunosorbent Assay (ELISA) kit.
Time frame
Baseline and 6 weeks post-therapy.3
Change in Salivary PLAP-1 (Asporin) Levels
Salivary Periodontal Ligament-Associated Protein-1 (PLAP-1) levels will be quantified using a specific human Enzyme-Linked Immunosorbent Assay (ELISA) kit.
Time frame
Baseline and 6 weeks post-therapy.Secondary outcomes
1
Change in Probing Pocket Depth (PPD)
PPD will be measured from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe.
Time frame
Baseline and 6 weeks post-therapy.2
Change in Clinical Attachment Level (CAL)
CAL will be measured from the cementoenamel junction (CEJ) to the base of the periodontal pocket using a UNC-15 periodontal probe.
Time frame
Baseline and 6 weeks post-therapy.3
Change in Plaque Index (PLI)
The amount of dental plaque will be assessed and scored clinically according to the Silness \& Löe (1964) Plaque Index.
Time frame
Baseline and 6 weeks post-therapy.4
Change in Gingival Index (GI)
Gingival inflammation will be assessed and scored clinically according to the Löe \& Silness (1963) Gingival Index.
Time frame
Baseline and 6 weeks post-therapy.Sponsors and contacts
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Source ClinicalTrials.gov