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Outcome of Bone Window Approach in Endodontic Microsurgery Using Novel Piezoelectric Device Versus Conventional Rotary Burs in the Treatment of Periapical Lesions - a Randomized Controlled Trial
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2024-09-19
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the bone window approach in endodontic microsurgery to treat patients with large periapical lesions and an intact buccal cortical plate. This study compares the outcomes of using a novel piezoelectric device versus conventional rotary burs to create the bone window. The goal is to preserve more bone structure and improve healing, as traditional methods may cause slower or incomplete cortical bone regeneration. This trial is a randomized controlled study aimed at finding the better surgical technique for these dental conditions. The study involves two groups: one where the bone window osteotomy is created using a piezoelectric device, and the other using conventional rotary burs in a slow-speed handpiece. Both procedures are performed during endodontic microsurgery on patients with symptomatic apical periodontitis and periapical lesions. The piezoelectric device cuts hard tissue selectively while preserving soft tissues, potentially offering advantages over traditional burs. The trial lasts at least one year to assess healing outcomes. Participants will undergo clinical and radiographic evaluations one year after surgery, including cone-beam computed tomography (CBCT) to measure bone healing and lesion status. The study assesses clinical signs, symptoms, and radiographic evidence of healing in the surgical area. Researchers will monitor and compare the effectiveness of both surgical techniques in preserving bone and improving patient recovery. Total participation duration includes pre-surgical imaging, surgery, and follow-up assessments over one year.
CONDITIONS
Brief Title
Outcome of Bone Window Approach in Endodontic Microsurgery Using Novel Piezoelectric Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Non-contributory medical history (ASA Class I or II)
- Symptomatic or persistent apical periodontitis with clinical signs and symptoms
- Periapical lesion of strictly endodontic origin with minimum 5 mm diameter on periapical radiography
- Radiographic evidence of intact buccal cortical plate with minimum 1 mm thickness on CBCT imaging
You will not qualify if you...
- Patients with systemic diseases such as diabetes mellitus, uncontrolled hypertension, hepatic or renal disease, or systemic bleeding disorders
- Pregnant patients
- Smokers
- Patients taking anticoagulant or antiplatelet drugs
- Teeth that are unrestorable, fractured, or perforated
- Teeth with endodontic-periodontal communication
- Teeth with deep periodontal pockets (probing depth greater than 4 mm)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with immediate recovery period
Participants undergo endodontic microsurgery where the bone window osteotomy is created using either a piezoelectric device or conventional rotary burs.
1 surgery visit and several post-operative visits
Duration - Up to 1 year after surgery
Participants are followed for clinical and radiographic assessment to monitor healing and outcomes after surgery.
Approximately 3 to 4 follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, India, 124001
Actively Recruiting
Research Team
S
sanjay tewari, MDS conservative dentistry 941
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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