Bone Remodeling and Non-surgical Periodontal Therapy

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05636683
• Other study ID #: 665622
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2022
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: March 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Procedure:
• Root surface debridement
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.

Locations

Country	Name	City	State
Iraq	College of Dentistry, University of Baghdad	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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