Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
- 1.To assess the alteration in the level of salivary osteopontin (OPN), osteonectin(ON) and histatin-1 following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals(one month and three months) .
- 2.To evaluate the response of clinical periodontal parameters ( plaque index ,bleeding on probing ,probing pocket depth ,clinical attachment loss)following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals (one month and three months)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2024
CompletedFirst Posted
Study publicly available on registry
February 21, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 21, 2024
February 1, 2024
8 months
January 8, 2024
February 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients.
salivary concentration of osteopontin between smoker and nonsmoker unstable periodontitis patients following NSPT at different time intervals.
baseline, one month and three months
Secondary Outcomes (2)
Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients.
baseline, one month and three months
Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients
baseline, one month and three months
Study Arms (2)
nonsmoker periodontitis patients
ACTIVE COMPARATORsmoker periodontitis patients
ACTIVE COMPARATORcigarette smoker more the three years ago
Interventions
sonic scaler for scaling and polishing. Graces curettes numbers(1-2,3-4,5-6,7-8,9-10,11-12,13-14)for root surfaces debridement(RSD), instructions and motivation for dental arch
Eligibility Criteria
You may qualify if:
- participants will be systemically healthy without history of any systemic diseases.
- hadn't underwent periodontal treatment during the previous 6 months and not taken medication during the previous 3 months.
- present with at least 20 teeth, those who only diagnosed with 4-6 mm probing pocket depth, generalized ,unstable periodontitis who had bone loss \> 30% , probing probing pocket depth at ≥4mm . Periodontitis cases were defined if clinical attachment loss was detected at ≥2 non- adjacent teeth or when buccal (facial) showed clinical attachment loss ≥3mm associated with probing pocket depth \>3mm at ≥ 2 teeth .
- The patients in the smokers group will be current smokers ( cigarette smokers) with smoking habit for over 3 years
You may not qualify if:
- Subjects have any intraoral plaque retentive factors such as those wearing partial denture, crown and bridges, and orthodontic appliances ,furcation involved teeth, overhang filling, tooth anomaly.
- receiving antibiotic therapy during the previous 3 months.
- those with systemic diseases such as diabetes mellitus, cardiovascular or renal diseases, etc…., pregnant or lactating women, not willing to participate or continue to conduct the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
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
- Iraq ,baghdad
Study Record Dates
First Submitted
January 8, 2024
First Posted
February 21, 2024
Study Start
March 1, 2024
Primary Completion
November 1, 2024
Study Completion
December 1, 2024
Last Updated
February 21, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share