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PeriodontitisNSPT-BiomarkerNCT07547202

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

A study testing Non-surgical periodontal therapy (Scaling and root planing) in people with Periodontitis and Smoking ( Cigarette), run by Al-Mustansiriyah University at 2 sites in Iraq.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontitis, Smoking ( Cigarette)
What is being tested?
Non-surgical periodontal therapy (Scaling and root planing)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesIraq
Study dates
1 Jan 2026to 1 Oct 2026
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

Iraq2 sites, 2 recruiting
  • Al-Sadr Specialized Dental Center

    Baghdad, Baghdad Governorate, 10001

    Recruiting
  • Sadr Specialized Dental Center

    Baghdad, Baghdad Governorate

    Hussein Abdul-Rassul Hatiem, B.D.S., M.Sc. Student, +9647703916382, husseinabdulrassol@uomustansiriyah.edu.iq

    Ghasaq Asim Abdulwahab, B.D.S., M.Sc., Ph.D., +9647901174767, ghasaq.a.abdulwahhab@uomustansiriyah.edu.iq

    Recruiting

Other trials in Iraq

About this study

Official title: The Significance of Non-Surgical Periodontal Therapy on Salivary Dkk-1, Sclerostin, and PLAP-1 Levels in Smoker and Non-Smoker Patients With Periodontitis: A Clinical Comparative Study

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.
Read the detailed description

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:

  • Baseline Visit: Participants will provide written informed consent, followed by the collection of unstimulated whole saliva via passive drooling. A full-mouth clinical examination will then be conducted using a UNC-15 periodontal probe. Clinical measurements include Plaque Index (PLI), Gingival Index (GI), Gingival Bleeding Index (GBI), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL).
  • Treatment Phase: Patients will receive standardized non-surgical periodontal therapy. This involves scaling at the first visit, followed by root planing after one week.
  • Follow-up Visit: Six weeks after completing the therapy, participants will return for a second saliva collection and a repeat of all clinical periodontal examinations.

Laboratory and Statistical Analysis:

  • Saliva samples will be kept in an ice box, centrifuged at 3000 rpm for 10 minutes, and the supernatant stored at -40 °C.
  • Salivary levels of Dkk-1, SOST, and PLAP-1 will be quantified using specific human ELISA kits.
  • Statistical analysis will assess intra-group and inter-group changes using SPSS, with a statistical significance level set at p ≤ 0.05.
Being tested
Non-surgical periodontal therapy (Scaling and root planing)
Keywords
Periodontitis, Smoking, Non-surgical periodontal therapy, Scaling and root planing, Salivary biomarkers, Dkk-1, Sclerostin, PLAP-1, SOST
Medical subject headings
Periodontitis, Cigarette Smoking, Smoking, Sclerosteosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-surgical periodontal therapy (Scaling and root planing)Procedure or surgery

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

Study groups in NCT07547202
Study groupRoleWhat they receive
SmokersActive comparator22 adult patients with Stage II or III periodontitis who currently smoke. They will receive standardized non-surgical periodontal therapy.
Receives: Procedure: Non-surgical periodontal therapy (Scaling and root planing)
Non-smokersActive comparator22 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.
Receives: Procedure: Non-surgical periodontal therapy (Scaling and root planing)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and 6 weeks post-therapy.

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and 6 weeks post-therapy.

  5. 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.

    Measured: Baseline and 6 weeks post-therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start1 Jan 2026
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547202
Sponsor's protocol ID
MU-DENT-2025-01
Acronym
NSPT-Biomarker
Status last verified
Apr 2026
First submitted
9 Apr 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: De-identified individual participant data will be made available upon reasonable request to the Principal Investigator.

Publications

  • 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

  • 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.

    PubMed 37006132
  • Liao C, Liang S, Wang Y, Zhong T, Liu X. Sclerostin is a promising therapeutic target for oral inflammation and regenerative dentistry. J Transl Med. 2022 May 13;20(1):221. doi: 10.1186/s12967-022-03417-4.

    PubMed 35562828
  • 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.

    PubMed 35789574

Questions about this trial

What is this clinical trial studying?

A study testing Non-surgical periodontal therapy (Scaling and root planing) in people with Periodontitis and Smoking ( Cigarette), run by Al-Mustansiriyah University at 2 sites in Iraq.

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 4 inclusion and 5 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Iraq. 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 Hussein Abdul-Rassul Hatiem, B.D.S., M.Sc. Student (+9647703916382, husseinabdulrassol@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Salivary Dickkopf-1 (Dkk-1) Levels (time frame: Baseline and 6 weeks post-therapy.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547202, which also lists 4 linked publications.

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 23 Apr 2026.

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