Effect of Non-Surgical Periodontal Therapy on Salivary Biomarkers in Smokers and Non-Smokers With Periodontitis

NCT07547202 | Recruiting

• 1 other identifier: MU-DENT-2025-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Periodontitis; Smoking ( Cigarette)

Keywords

Periodontitis; Smoking; Non-surgical periodontal therapy; Scaling and root planing; Salivary biomarkers; Dkk-1; Sclerostin; PLAP-1; SOST

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and 6 weeks post-therapy.

Secondary Outcomes (5)

• Change in Probing Pocket Depth (PPD)

  Baseline and 6 weeks post-therapy.

• Change in Clinical Attachment Level (CAL)

  Baseline and 6 weeks post-therapy.

• Change in Plaque Index (PLI)

  Baseline and 6 weeks post-therapy.

• Change in Gingival Index (GI)

  Baseline and 6 weeks post-therapy.

• Change in Gingival Bleeding Index (GBI)

  Baseline and 6 weeks post-therapy.

Study Arms (2)

Smokers

ACTIVE COMPARATOR

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)

Non-smokers

ACTIVE COMPARATOR

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)

Interventions

Non-surgical periodontal therapy (Scaling and root planing) PROCEDURE

Standardized non-surgical periodontal therapy performed over two visits (scaling at the first visit and root planing after one week).

Non-smokers; Smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy.
• Diagnosed with Stage II and III periodontitis.
• Presence of ≥ 20 teeth (excluding third molars).
• Current smoker OR non-smoker

You may not qualify if:

• 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.
• Alcohol use.

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (2)

Al-Sadr Specialized Dental Center

Baghdad, Baghdad Governorate, 10001, Iraq

RECRUITING

Sadr Specialized Dental Center

Baghdad, Baghdad Governorate, Iraq

RECRUITING

Related Publications (4)

• Saraç Atagün Ö, Baltacıoğlu E, Alver A, Balaban Yücesan F, Yuva P, Aslan Kehribar M, et al. Effects of smoking on local and systemic oxidative stress markers in individuals with periodontitis. Northwestern Med J. 2024;4(4):195-20. https://doi.org/10.54307/2024.NWMJ.71

  BACKGROUND

• Gur B, Afacan B, Cevik O, Kose T, Emingil G. Gingival crevicular fluid periodontal ligament-associated protein-1, sclerostin, and tumor necrosis factor-alpha levels in periodontitis. J Periodontol. 2023 Oct;94(10):1166-1175. doi: 10.1002/JPER.22-0750. Epub 2023 Apr 19.

  PMID: 37006132 BACKGROUND

• Liao, C., Liang, S., Wang, Y. et al. Sclerostin is a promising therapeutic target for oral inflammation and regenerative dentistry. J Transl Med 20, 221 (2022). https://doi.org/10.1186/s12967-022-03417-4

  BACKGROUND

• Azab E, Attia A, Yaghmoor W, Aldahlawi S, Youssef AR. The Impact of Nonsurgical Periodontal Therapy on Serum Levels of Dickkopf-Related Protein-1 in Smokers and Nonsmokers with Periodontitis: A Prospective Comparative Study. Clin Cosmet Investig Dent. 2022 Jun 28;14:191-198. doi: 10.2147/CCIDE.S362801. eCollection 2022.

  PMID: 35789574 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Cigarette Smoking; Smoking; Sclerosteosis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tobacco Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Hussein Abdul-Rassul Hatiem, B.D.S., M.Sc. Student

  College of Dentistry / Mustansiriyah University

  PRINCIPAL INVESTIGATOR

• Ghasaq Asim Abdulwahab, B.D.S., M.Sc., Ph.D.

  College of Dentistry / Mustansiriyah University

  STUDY DIRECTOR

Central Study Contacts

Hussein Abdul-Rassul Hatiem, B.D.S., M.Sc. Student

CONTACT

+9647703916382; husseinabdulrassol@uomustansiriyah.edu.iq

Ghasaq Asim Abdulwahab, B.D.S., M.Sc., Ph.D.

CONTACT

+9647901174767; ghasaq.a.abdulwahhab@uomustansiriyah.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to two parallel groups based on their smoking status: current smokers (n=22) and non-smokers (n=22). Both groups will receive the identical intervention of standardized non-surgical periodontal therapy (scaling and root planing). Clinical periodontal parameters and salivary biomarker levels will be evaluated before treatment (baseline) and after treatment (6-week follow-up) to assess the within-group changes. Additionally, the baseline and post-therapy results will be compared between the two groups to evaluate the impact of smoking on treatment response.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

IR (2)