Non Surgical Periodontal TherapyNCT06270004
Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients
A study testing nonsurgical periodontal therapy in people with Non Surgical Periodontal Therapy, run by University of Baghdad.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non Surgical Periodontal Therapy
- What is being tested?
- nonsurgical periodontal therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
- 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) .
- 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)
Read the detailed description
the study include nonsurgical periodontal therapy for smoker and non smoker patients with unstable periodontitis and evaluate the clinical periodontal parameters ( plaque index, bleeding on probing , probing pocket depth ,clinical attachment loss) and 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)
- Conditions
- Non Surgical Periodontal Therapy
- Being tested
- nonsurgical periodontal therapy
- Keywords
- osteonectin, osteopontin, histatin1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonsurgical periodontal therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| nonsmoker periodontitis patients | Active comparator | Not described Receives: Other: nonsurgical periodontal therapy |
| smoker periodontitis patients | Active comparator | cigarette smoker more the three years ago Receives: Other: nonsurgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
salivary concentration of osteonectin between smoker and nonsmoker unstable periodontitis patients following NSPT at different time intervals .
Measured: 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
salivary concentration of histatin1 between smoker and nonsmoker unstable periodontitis patients following NSPT at different time intervals.
Measured: baseline, one month and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Surgical Periodontal TherapyStudies 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
- Model description
- smoker and non smoker patients with unstable periodontitis
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06270004
- Sponsor's protocol ID
- nonsurgical periodontal
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients
- ClinicalTrials.gov ID
- NCT06270004
- Acronym / sponsor ID
- nonsurgical periodontal
- Conditions
- Non Surgical Periodontal Therapy
- Keywords
- osteonectin, osteopontin, histatin1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 Feb 2024 (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.
- 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) .
- 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)
Detailed description
the study include nonsurgical periodontal therapy for smoker and non smoker patients with unstable periodontitis and evaluate the clinical periodontal parameters ( plaque index, bleeding on probing , probing pocket depth ,clinical attachment loss) and 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)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- smoker and non smoker patients with unstable periodontitis
| Arm | Type | Receives |
|---|---|---|
| nonsmoker periodontitis patients | Active comparator | Other: nonsurgical periodontal therapy |
| smoker periodontitis patients | Active comparator | Other: nonsurgical periodontal therapycigarette smoker more the three years ago |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| nonsurgical periodontal therapysonic 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 | Other | nonsmoker periodontitis patients, smoker periodontitis patients |
Primary outcome
Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients.
Time frame: baseline, one month and three months
salivary concentration of osteopontin between smoker and nonsmoker unstable periodontitis patients following NSPT at different time intervals.
2 secondary outcomes
Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients.
Time frame: 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
Time frame: baseline, one month and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing nonsurgical periodontal therapy in people with Non Surgical Periodontal Therapy, run by University of Baghdad.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aqeel Ali, baccalaureus (+96407705518935, aqeel.ali2205@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients. (time frame: baseline, one month and three 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 21 Feb 2024.