An interventional study of Non-surgical periodontal therapy (Scaling and root planing) in Periodontitis and Smoking ( Cigarette), sponsored by Al-Mustansiriyah University. Recruiting at 2 sites in Iraq. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Al-Mustansiriyah University · Not applicable, Interventional, and Treatment
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.
Smoking is known to adversely affect the periodontium by altering cytokine production, impairing neutrophil function, and causing vasoconstriction that masks clinical inflammation. Because conventional diagnostic methods primarily measure past tissue destruction, there is growing interest in utilizing salivary biomarkers for real-time monitoring of disease activity. Specifically, Dickkopf-1 (Dkk-1) and Sclerostin (SOST) are elevated in periodontitis and actively suppress bone formation by antagonizing the Wnt/β-catenin pathway. Conversely, Periodontal Ligament-Associated Protein-1 (PLAP-1) plays a protective role in maintaining the periodontal ligament, and its presence in saliva may indicate active degradation. The collective behavior of these biomarkers in response to therapy among smokers is not fully understood.
This non-randomized comparative clinical trial aims to investigate the impact of smoking on these salivary biomarkers before and after non-surgical periodontal therapy. A total of 44 systemically healthy adult participants with Stage II and III periodontitis will be enrolled. The participants will be divided into two groups of 22: current smokers and non-smokers (defined as having never smoked or quit >5 years ago).
Study Procedures:
Laboratory and Statistical Analysis:
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Exclusion Criteria:
22 adult patients with Stage II or III periodontitis who currently smoke. They will receive standardized non-surgical periodontal therapy.
Procedure: Non-surgical periodontal therapy (Scaling and root planing)
22 adult patients with Stage II or III periodontitis who have never smoked or quit more than 5 years ago. They will receive standardized non-surgical periodontal therapy.
Procedure: Non-surgical periodontal therapy (Scaling and root planing)
Standardized non-surgical periodontal therapy performed over two visits (scaling at the first visit and root planing after one week).
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.
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.
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.
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.
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.
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.
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.
Change in Gingival Bleeding Index (GBI)
The presence or absence of gingival bleeding will be assessed clinically according to the Ainamo \& Bay (1975) Gingival Bleeding Index.
Time frame: Baseline and 6 weeks post-therapy.
Plan to share: Undecided — De-identified individual participant data will be made available upon reasonable request to the Principal Investigator.
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