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PeriodontitisNSPTNCT07367737

Histatin-1 Levels in Smokers and Non-smokers With Periodontitis Patients: A Comparative Study Before and After Nonsurgical Periodontal Therapy

A study testing Non Surgical Periodontal Treatment in people with Periodontitis and Periodontal Diseases, run by University of Baghdad at 1 site in Iraq.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study evaluated the impact of smoking on salivary histatin-1 levels and clinical healing in 50 patients with unstable periodontitis (25 smokers and 25 non-smokers) undergoing non-surgical periodontal therapy (NSPT). Read more about this study

Who is it for?
Any age, men onlyHealthy volunteers can take part
Conditions the study is for
Periodontitis, Periodontal Diseases
What is being tested?
Non Surgical Periodontal Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIraq
Study dates
1 May 2025to 10 Feb 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 Any age
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • the present study required participants to be systemically healthy, with no history of systemic diseases such as diabetes mellitus, cardiovascular disease, or renal disease.
  • Participants had not undergone periodontal treatment in the past six months or taken any medication in the last three months.
  • They also needed to have at least 20 teeth and be diagnosed with moderate periodontitis, characterized by a PPD of 4-6 mm, generalized, unstable periodontitis.

Who cannot join

  • the presence of intraoral plaque-retentive factors such as crowns, bridges, partial dentures, orthodontic appliances, furcation-involved teeth, overhanging restorations, and tooth anomalies.
  • Patients who had received antibiotic therapy within the previous three months.

Trial locations and contacts

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

Iraq1 site
  • university of Baghdad, college of dentistry

    Baghdad, Medical City, 10049

Other trials in Iraq

About this study

Official title: Histatin-1 Levels in Smokers and Non-smokers With Periodontitis Patients: A Comparative Study Before and After Nonsurgical Periodontal Therapy (Prospective Clinical Trial)

This study evaluated the impact of smoking on salivary histatin-1 levels and clinical healing in 50 patients with unstable periodontitis (25 smokers and 25 non-smokers) undergoing non-surgical periodontal therapy (NSPT). By measuring clinical parameters like probing depth and clinical attachment level alongside ELISA-based protein analysis at baseline, one month, and three months post-treatment, the researchers sought to determine if the impaired wound healing typically seen in smokers correlates with a suppressed expression of this specific salivary protein.

Read the detailed description

Periodontal disease is a chronic progressive destructive disease of the tissues supporting the teeth, collectively known as the periodontium. The main clinical parameters of periodontal diseases are clinical attachment loss , radiographic reduced alveolar bone height, probing depth and bleeding on probing. If untreated, teeth can be lost, but most cases can be prevented and treated . In recent definitions of periodontitis, smoking is considered the most important environmental risk factor. . Furthermore, The severity of periodontitis is directly influenced by the smoking habits of an individual and the number of cigarettes smoked per day. Smoking increases the risk of periodontitis , by compromising the host's immune response, thereby reducing the ability to combat periodontal pathogens. Additionally, it impairs the circulation of blood to periodontal tissues, which hinders healing processes and fosters an environment conducive to bacterial proliferation. These factors collectively contribute to enhanced inflammation, periodontal tissue destruction, and the accelerated progression of periodontal disease.

In general, Histatin, a group of histidine-rich proteins, exhibit diverse functions, including antifungal, bactericidal, and enamel-protective activities. Histatin-1 is a naturally occurring antimicrobial peptide found in human saliva, known for its role in oral health and immunity. It has garnered significant attention in the context of periodontal disease due to its multifaceted biological functions. Histatin-1 demonstrates significant antibacterial efficacy against many oral infections, involving bacteria, fungi, and viruses. In periodontal disease, pathogenic bacteria such as Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola play a critical role in disease progression. Histatin-1 disrupts the cell membranes of these pathogens, leading to their destruction and helping to maintain microbial balance in the oral cavity.

Histatin-1 has been shown to modulate inflammatory responses by inhibiting the production of pro-inflammatory cytokines, such as IL-6, IL-8, and TNF-α. Therefore, reducing tissue damage and promotes healing in periodontal tissues6. Histatin-1 plays a significant role in promoting the migration and proliferation of epithelial cells, which is crucial for the regeneration of periodontal tissues. It accelerates wound closure and tissue repair, making it a potential therapeutic agent for managing periodontal lesions and promoting periodontal regeneration.

Biofilm formation by pathogenic bacteria is a crucial determinant in the onset and progression of periodontal disease. Histatin-1 has been found to inhibit biofilm formation by interfering with bacterial adhesion and aggregation, this property helps prevent the colonization of pathogenic bacteria on tooth surfaces and periodontal tissues. Histatin-1 interacts with host immune cells, such as neutrophils and macrophages, enhancing their ability to combat infections. It also modulates the immune response to prevent excessive inflammation, which can lead to tissue destruction in periodontal disease. Furthermore, research has broadened the range of cell types responsive to histatin-1, demonstrating its capacity to stimulate osteogenic differentiation and facilitate mineralization in pre-osteoblasts, as well as mesenchymal cells sourced from tooth pulp and apical papilla. These findings offer fresh perspectives on the physiological significance of histatin-1's effects across diverse cell populations within the oral cavity. Given its antimicrobial, anti-inflammatory, and wound-healing properties, Histatin-1 is being explored as a potential therapeutic agent for periodontal disease. It could be incorporated into mouthwashes, gels, or local drug delivery systems to target periodontal pockets and promote oral health Non-surgical periodontal approach, including scaling and root surface debridement (RSD) as well as oral hygiene instructions, is the most effective treatment for periodontitis . The goal of the treatment is to eliminate the biofilm that has built up on the teeth surfaces ., supra and subgingival, and delay the recolonization of the sites by periodontopathogens. Studies indicate that these treatments can halt the progression of periodontitis in pockets ranging from shallow to moderate. Salivary biomarkers serve as valuable diagnostic and prognostic indicators for periodontal disease, as well as markers for monitoring the healing process .

Being tested
Non Surgical Periodontal Treatment
Keywords
periodontitis, NSPT
Medical subject headings
Periodontitis, Periodontal Diseases

What participants receive

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

  • Non Surgical Periodontal TreatmentProcedure or surgery

    All patients underwent clinical evaluation and were provided with oral hygiene instructions followed by supragingival full-mouth scaling with an ultrasonic scaler (WOODPECKER® UDS-K). They were also told to use dental floss and interdental brushes on need and to brush their teeth twice a day. The examiner provided each patient with a toothbrush and toothpaste. The subjects were scheduled to undergo non-surgical periodontal treatment of the clinic one week after the previous appointment, that included instructions on oral hygiene and periodontal treatment with root debridement with Gracey curette

  • Non Surgical Periodontal TreatmentProcedure or surgery

    All patients underwent clinical evaluation and were provided with oral hygiene instructions followed by supragingival full-mouth scaling with an ultrasonic scaler (WOODPECKER® UDS-K). They were also told to use dental floss and interdental brushes on need and to brush their teeth twice a day. The examiner provided each patient with a toothbrush and toothpaste. The subjects were scheduled to undergo non-surgical periodontal treatment of the clinic one week after the previous appointment, that included instructions on oral hygiene and periodontal treatment with root debridement with Gracey curette.

Study groups in NCT07367737
Study groupRoleWhat they receive
smokers periodontitisOther25 smokers with probing depth (4-6mm), unstable periodontitis were enrolled in the study and underwent NSPT. Saliva samples were obtained prior to, and one month and three months subsequent to, NSPT. By employing an enzyme-linked immunosorbent assay (ELISA)
Receives: Procedure: Non Surgical Periodontal Treatment
non smokers periodontitisOther25 non smokers with probing depth (4-6mm), unstable periodontitis were enrolled in the study and underwent NSPT. Saliva samples were obtained prior to, and one month and three months subsequent to, NSPT. By employing an enzyme-linked immunosorbent assay (ELISA)
Receives: Procedure: Non Surgical Periodontal Treatment

What is being measured

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

  1. Measuring the level of salivary histatin-1 in nonsmoker and smoker patients with unstable periodontitis over the periods of one month, and three months following NSPT

    Before the clinical examination, 1 mL of unstimulated saliva was collected from every participant in the morning appointment using the drooling method by Navazesh . Patients were asked to remain fasting for 30 min. Saliva was collected via 30-mm diameter round-bottom polypropylene tubes (50-ml Falcon® tubes). Then, 1 ml of saliva was transferred into a 1.5 ml Eppendorf tube contained 10 μl of 2× protease inhibitor (Sigma-Aldrich, St. Louis, MO, USA). The samples were subsequently centrifuged for 5 minutes at 3000 rpm, and the supernatant was frozen at -70 °C for subsequent analyses.

    Measured: baseline,1 month, 3 months

Timeline

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

  1. First posted26 Jan 2026
  2. Study start1 May 2025
  3. Primary completion29 Jan 2026 (estimated)
  4. Study completion10 Feb 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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07367737
Sponsor's protocol ID
UBaghdad
Acronym
NSPT
Status last verified
Dec 2025
First submitted
23 Nov 2025
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: to disseminate the research idea

Questions about this trial

What is this clinical trial studying?

A study testing Non Surgical Periodontal Treatment in people with Periodontitis and Periodontal Diseases, run by University of Baghdad at 1 site 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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring the level of salivary histatin-1 in nonsmoker and smoker patients with unstable periodontitis over the periods of one month, and three months following NSPT (time frame: baseline,1 month, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Jan 2026.

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