Bone Remodeling and Non-surgical Periodontal Therapy

Study Overview
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Brief Summary
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Previous studied have investigated the pathophysiological role and expression of Cathepsin K (Ctsk) , receptor activator of the NF-κB ligand (RANKL) and periostin in active periodontitis and peri-implantitis lesions. However, the potential influence of non-surgical periodontal therapy including scaling and root planning on the bone remodeling markers level over different trial times have not well determined. Thus, the current research is conducted to address this influence. Thus, the research question will be: In patients with periodontitis, does the level of bone remodeling markers altered after successful NSPT during different healing time periods?

Official Title
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Evaluation of Bone Remodeling Markers Following Non-surgical Periodontal Therapy in Periodontitis Patients (Prospective Clinical Trial)

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: Root surface debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both males and females. Unstable periodontitis. No previous periodontal treatment is conducted during the past 6 months. Good general health without history of any systemic diseases. Present with at least 20 teeth. Non-smokers. Exclusion Criteria: Subjects have any intraoral plaque retentive factors such as those wearing partial denture, crown and bridges, and orthodontic appliances. Subjects receiving antibiotic therapy during the previous 3 months. Pregnant or lactating women. Smokers. Not willing to participate or continue to conduct the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periodontitis treated with Root surface debridement<br>Immediately after inclusion in the study, the patient's examination with saliva sampling will be conducted as follows: At a base line visit (Zero time visit), subjects will be examined for clinical periodontal parameters, their saliva samples will be collected, and then receiving full scaling using ultrasonic device, and oral hygiene instructions and motivation. After one week, the same clinical parameters, saliva sampling will be taken, and received full root surface debridement (RSD) using curette hand instruments (Gracey, USA) (First visit). One month and three months after first visit, the same clinical measurements, saliva will characterize as second and third visits, respectively. | Procedure: Root surface debridement<br>* subjects will be examined for clinical periodontal parameters, their saliva samples will be collected, and then receiving full scaling using ultrasonic device, and oral hygiene instructions and motivation. After one week, the same clinical parameters, saliva sampling will be taken, and received full root surface debridement (RSD) using curette hand instruments (Gracey, USA) (First visit). One month and three months after first visit, the same clinical measurements, saliva will characterize as second and third visits, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone remodeling markers including salivary RANKL | To investigate the alterations in the level of salivary RANKL pg/ml following Non-surgical periodontal therapy in unstable periodontitis patients during different healing time periods. | At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit | 
| Bone remodeling markers including salivary Cathepsin k | To investigate the alterations in the level of salivary Cathepsin k pg/ml following Non-surgical periodontal therapy in unstable periodontitis patients during different healing time periods. | At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit | 
| Bone remodeling markers including salivary periostin | To investigate the alterations in the level of salivary periostin pg/ml following Non-surgical periodontal therapy in unstable periodontitis patients during different healing time periods. | At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical periodontal parameters including Bleeding on probing | To measure Clinical periodontal parameters including Bleeding on probing following Non-surgical periodontal therapy in unstable periodontitis patients during different healing time periods. | At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit | 
| Clinical periodontal parameters including probing pocket depth | To measure Clinical periodontal parameters including probing pocket depth following Non-surgical periodontal therapy in unstable periodontitis patients during different healing time periods. | At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit | 
| Clinical periodontal parameters including clinical attachment loss | To measure Clinical periodontal parameters including clinical attachment loss following Non-surgical periodontal therapy in unstable periodontitis patients during different healing time periods. | At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit |