Bone Remodeling and Non-surgical Periodontal Therapy

NCT05636683 | Unknown

• 1 other identifier: 665622
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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?

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Periodontitis treated with Root surface debridement

EXPERIMENTAL

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

Interventions

Root surface debridement PROCEDURE

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.

Periodontitis treated with Root surface debridement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, +964, Iraq

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Firas B. Al-Taweel, PhD

  Periodontics department, College of Dentistry/University of Baghdad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: February 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

IR (1)