Bone Remodeling and Non-surgical Periodontal Therapy

Sponsor
University of Baghdad (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05636683
Collaborator
(none)
25
1
1
12.9
1.9

Study Details

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?

Condition or Disease Intervention/Treatment Phase
  • Procedure: Root surface debridement
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Bone Remodeling Markers Following Non-surgical Periodontal Therapy in Periodontitis Patients (Prospective Clinical Trial)
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Periodontitis treated with 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 College of Dentistry, University of Baghdad Baghdad Iraq +964

Sponsors and Collaborators

  • University of Baghdad

Investigators

  • Study Director: Firas B. Al-Taweel, PhD, Periodontics department, College of Dentistry/University of Baghdad

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Firas Bashir Hashim Al-Taweel, Assistant Professor, University of Baghdad
ClinicalTrials.gov Identifier:
NCT05636683
Other Study ID Numbers:
  • 665622
First Posted:
Dec 5, 2022
Last Update Posted:
Dec 15, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 15, 2022