Back to resultsBone Remodeling and Non-surgical Periodontal Therapy
Primary Purpose
Periodontal Diseases
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Root surface debridement
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
Eligibility Criteria
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.
Sites / Locations
- College of Dentistry, University of Baghdad
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Periodontitis treated with Root surface debridement
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05636683
First Posted
November 23, 2022
Last Updated
December 12, 2022
Sponsor
University of Baghdad
1. Study Identification
Unique Protocol Identification Number
NCT05636683
Brief Title
Bone Remodeling and Non-surgical Periodontal Therapy
Official Title
Evaluation of Bone Remodeling Markers Following Non-surgical Periodontal Therapy in Periodontitis Patients (Prospective Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Periodontitis treated with Root surface debridement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Root surface debridement
Intervention Description
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 Measure Information:
Title
Bone remodeling markers including salivary RANKL
Description
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.
Time Frame
At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
Title
Bone remodeling markers including salivary Cathepsin k
Description
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.
Time Frame
At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
Title
Bone remodeling markers including salivary periostin
Description
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.
Time Frame
At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
Secondary Outcome Measure Information:
Title
Clinical periodontal parameters including Bleeding on probing
Description
To measure Clinical periodontal parameters including Bleeding on probing following Non-surgical periodontal therapy in unstable periodontitis patients during different healing time periods.
Time Frame
At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
Title
Clinical periodontal parameters including probing pocket depth
Description
To measure Clinical periodontal parameters including probing pocket depth following Non-surgical periodontal therapy in unstable periodontitis patients during different healing time periods.
Time Frame
At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
Title
Clinical periodontal parameters including clinical attachment loss
Description
To measure Clinical periodontal parameters including clinical attachment loss following Non-surgical periodontal therapy in unstable periodontitis patients during different healing time periods.
Time Frame
At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Firas B. Al-Taweel, PhD
Organizational Affiliation
Periodontics department, College of Dentistry/University of Baghdad
Official's Role
Study Director
Facility Information:
Facility Name
College of Dentistry, University of Baghdad
City
Baghdad
ZIP/Postal Code
+964
Country
Iraq
12. IPD Sharing Statement
Learn more about this trial
Bone Remodeling and Non-surgical Periodontal Therapy
We'll reach out to this number within 24 hrs