Clinical trial NCT05636683: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Bone remodeling markers including salivary RANKL
timeFrame: At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
measure: Bone remodeling markers including salivary Cathepsin k
timeFrame: At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
measure: Bone remodeling markers including salivary periostin
timeFrame: At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
Secondary outcomes:
measure: Clinical periodontal parameters including Bleeding on probing
timeFrame: At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
measure: Clinical periodontal parameters including probing pocket depth
timeFrame: At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
measure: Clinical periodontal parameters including clinical attachment loss
timeFrame: At a base line visit (Zero time visit), After one week (first visit), and One month and three months after first visit
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry, University of Baghdad
Study officials:
affiliation: Periodontics department, College of Dentistry/University of Baghdad
name: Firas B. Al-Taweel, PhD
role: STUDY_DIRECTOR
References: