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

NCT07367737 | Enrolling By Invitation

• 1 other identifier: UBaghdad
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Periodontal Diseases; Periodontitis

Keywords

periodontitis, NSPT

Outcome Measures

Primary Outcomes (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.

  baseline,1 month, 3 months

Study Arms (2)

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)

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)

Procedure: Non Surgical Periodontal Treatment

Interventions

Non Surgical Periodontal Treatment PROCEDURE

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 smokers periodontitis

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

university of Baghdad, college of dentistry

Baghdad, Medical City, 10049, Iraq

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

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

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: January 26, 2026
• Study Start: May 1, 2025
• Primary Completion: January 29, 2026
• Study Completion: February 10, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from 1/5/2025 to 1/12/2025

Locations

IR (1)