- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07452640
Vector® System vs Mini-Five Curettes in Non-Surgical Periodontal Therapy (VECTOR-RCT)
A Randomized Single-Blind Clinical Trial Comparing the Clinical and Radiographic Outcomes of the Vector® Ultrasonic System and Minimally Invasive Hand Instrumentation (Mini-Five Curettes) in Non-Surgical Periodontal Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Periodontitis is a chronic inflammatory disease leading to the destruction of supporting periodontal tissues. Non-surgical periodontal therapy is the first-line treatment and includes mechanical debridement using manual or ultrasonic instruments. The Vector®️ ultrasonic system is designed to provide minimally invasive debridement with reduced trauma to root surfaces and surrounding tissues.
This randomized, controlled, single-blind clinical trial will compare the effectiveness of the Vector®️ system and mini-five curettes in patients diagnosed with periodontitis. Participants will be randomly allocated into two groups: the ultrasonic instrumentation group (Vector®️ system) and the manual instrumentation group (mini-five curettes).
Clinical parameters including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) will be recorded at baseline and at 1, 3, 6, and 12 months. Standardized radiographic examinations will be performed at baseline, 6 months, and 12 months to evaluate radiographic bone level changes.
The primary outcome measure is the change in clinical attachment level at 12 months. Secondary outcomes include probing depth reduction, bleeding on probing, and radiographic bone level changes.
The study is conducted at Hacettepe University Faculty of Dentistry, Department of Periodontology. Ethical approval has been obtained from the Hacettepe University Clinical Research Ethics Committee.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Recruiting
- Hacettepe University Facultyof Dentistry
-
Contact:
- Abdullah Cevdet Akman, Prof. Dr.
- Phone Number: 03123052217
- Email: abdullahcevdet.akman@hacettepe.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adults aged 18-65 years Willing to participate and provided written informed consent Presence of single-rooted teeth in both maxilla and mandible with vertical bone defects (radiographic intrabony defect ≥2 mm and probing depth ≥5 mm) Diagnosis of Stage III or Stage IV periodontitis Systemically healthy or Systemically healthy patients or American Society of Anesthesiologists (ASA) physical status I-II.
Exclusion Criteria:
Periodontal treatment within the last 6 months Teeth with furcation involvement Smoking more than 10 cigarettes per day Pregnancy Age under 18 years Patients unwilling to attend regular follow-up visits Previously endodontically treated tooth at the treatment site Poor compliance with oral hygiene instructions Single-rooted teeth with horizontal bone loss extending close to the apical third Teeth with mobility grade II or III Previous flap surgery or regenerative periodontal treatment at the study site
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vector System Group
Participants receive non-surgical periodontal therapy using the Vector®️ ultrasonic system.
|
Minimally invasive ultrasonic instrumentation used for non-surgical periodontal therapy.
|
|
Active Comparator: Mini-Five Curettes Group
Participants receive non-surgical periodontal therapy using mini-five curettes.
|
Manual curette instrumentation used for non-surgical periodontal therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Probing Depth(PD)
Time Frame: Baseline,1 month, 3 months, 6 months, and 12 months
|
Change in periodontal probing depth (in millimeters) from baseline to follow-up after non-surgical periodontal therapy using Vector®️ ultrasonic system compared with mini-five curettes.
|
Baseline,1 month, 3 months, 6 months, and 12 months
|
|
Change in Radiographic Vertical Bone Defect Depth
Time Frame: Baseline, 6 months, and 12 months
|
Change in radiographic vertical bone defect depth (mm) assessed on standardized radiographs at baseline, 6 months, and 12 months after treatment.
|
Baseline, 6 months, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Sensitivity(VAS Score)
Time Frame: During treatment and immediately after treatment
|
Pain sensitivity assessed using a visual analog scale (VAS) during and immediately after the treatment session.
|
During treatment and immediately after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abdullah Cevdet Akman, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THD-2026-22611
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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