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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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
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 .
- Conditions
- Periodontitis, Periodontal Diseases
- 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 group | Role | What they receive |
|---|---|---|
| smokers periodontitis | Other | 25 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 periodontitis | Other | 25 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.
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.
- First posted26 Jan 2026
- Study start1 May 2025
- Primary completion29 Jan 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqeel Ali, University of Baghdad
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07367737
- Acronym / sponsor ID
- NSPT / UBaghdad
- Conditions
- Periodontitis, Periodontal Diseases
- Keywords
- periodontitis, NSPT
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 29 Jan 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 .
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smokers periodontitis | Other | Procedure: Non Surgical Periodontal Treatment25 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) |
| non smokers periodontitis | Other | Procedure: Non Surgical Periodontal Treatment25 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) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Surgical Periodontal TreatmentAll 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 | Procedure or surgery | non smokers periodontitis |
| Non Surgical Periodontal TreatmentAll 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. | Procedure or surgery | smokers periodontitis |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Yes. to disseminate the research idea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.