Chronic Periodontitis, Periodontitis
Conditions
Keywords
Non-Surgical Periodontal Therapy • Vector System • Ultrasonic Instrumentation • Mini-Five Curettes • Clinical Attachment Level • Radiographic Bone Loss
Brief summary
This randomized clinical trial aims to compare the clinical and radiographic outcomes of the Vector®️ ultrasonic system and mini-five curettes in non-surgical periodontal therapy. Patients diagnosed with periodontitis will be randomly assigned to either ultrasonic instrumentation or manual instrumentation. Clinical periodontal parameters and radiographic bone level changes will be evaluated at baseline, 1, 3, 6, and 12 months. The primary objective is to assess differences in clinical attachment level and probing depth reduction between the two treatment modalities.
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.
Interventions
DEVICEVector® Ultrasonic System
Minimally invasive ultrasonic instrumentation used for non-surgical periodontal therapy.
DEVICEMini-Five Curettes
Manual curette instrumentation used for non-surgical periodontal therapy.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The examiner responsible for clinical measurements is blinded to the treatment allocation.
Intervention model description
Participants will be randomly assigned to two parallel groups: ultrasonic instrumentation using the Vector®️ system or manual instrumentation using mini-five curettes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Depth(PD) | 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. |
| Change in Radiographic Vertical Bone Defect Depth | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Sensitivity(VAS Score) | During treatment and immediately after treatment | Pain sensitivity assessed using a visual analog scale (VAS) during and immediately after the treatment session. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAbdullah Cevdet Akman
Hacettepe University
Outcome results
None listed