Bone Remodeling and Non-surgical Periodontal Therapy

Not Applicable

• Conditions: Periodontal Diseases
• Interventions: Procedure: Root surface debridement

• Registration Number: NCT05636683
• Lead Sponsor: University of Baghdad

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-11-23
• Status Verified: 2022-12
• Study First Posted: 2022-12-05
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-15
• Primary Completion: 2023-01-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Both males and females.
2. Unstable periodontitis.
3. No previous periodontal treatment is conducted during the past 6 months.
4. Good general health without history of any systemic diseases.
5. Present with at least 20 teeth.
6. Non-smokers.

Exclusion Criteria

1. Subjects have any intraoral plaque retentive factors such as those wearing partial denture, crown and bridges, and orthodontic appliances.
2. Subjects receiving antibiotic therapy during the previous 3 months.
3. Pregnant or lactating women.
4. Smokers.
5. Not willing to participate or continue to conduct the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Periodontitis treated with Root surface debridement	Root surface debridement	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.

Primary Outcome Measures

Name	Time	Method
Bone remodeling markers including salivary RANKL	At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit	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.
Bone remodeling markers including salivary Cathepsin k	At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit	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.
Bone remodeling markers including salivary periostin	At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

College of Dentistry, University of Baghdad; 🇮🇶 Baghdad, Iraq