NCT06270004

Brief Summary

  1. 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. 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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

January 8, 2024

Last Update Submit

February 19, 2024

Conditions

Keywords

osteonectinosteopontinhistatin1

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 COMPARATOR
Other: nonsurgical periodontal therapy

smoker periodontitis patients

ACTIVE COMPARATOR

cigarette smoker more the three years ago

Other: nonsurgical periodontal therapy

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

nonsmoker periodontitis patientssmoker periodontitis patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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
Model Details: smoker and non smoker patients with unstable periodontitis
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