Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems

Plovdiv Medical University

Status: Completed

Conditions: Tooth Extraction Status Nos

Treatments: Procedure: Tooth extraction; Device: Conventional Extraction Forceps; Device: Physics Forceps; Device: Benex

Study type: Interventional

Funder types: Other

Identifiers

NCT06496906

DPDP02/2021

Details and patient eligibility

About

The aim of the study is to compare the effectiveness of the vertical extraction system Benex and Physics forceps with the conventional extraction tools (extraction forceps and elevators) in the early wound healing period after tooth extraction, as means for minimally invasive tooth extraction.

All patients aged 18 years and over who require closed tooth extraction with good oral hygiene were eligible for participation.

Participants were randomly allocated to tooth extraction with either Benex, Physics forceps or conventional extraction tools using box randomization. Patients are followed up during the recovery period to assess pain and early wound healing, while at the time of extraction, success and buccal cortical plate fracture were evaluated.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with teeth indicated for closed extraction
• Teeth with at least 1mm of tissue above the bone level
• Patients without contraindications for surgical intervention (ASA 1 or 2)
• Patients with good oral hygiene

Exclusion criteria

• Patients with severe systemic conditions or immunosuppression
• Teeth with mobility greater than Grade 1
• Teeth indicated for open surgical extraction
• Patients with acute odontogenic infections
• Drug or alcohol abuse
• Patients with psychiatric conditions
• Patients on anticoagulant or antiaggregant drugs refusing to undergo prior tests and preparation for tooth extraction
• Patients on chemotherapy, radiotherapy, or oral bisphosphonate intake

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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116 participants in 3 patient groups

Benex tooth extraction

Experimental group

Description:

This is the first study group where patients undergo extractions with presumably the vertical tooth extraction system Benex.

Treatment:

Device: Benex

Procedure: Tooth extraction

Physics forceps extraction

Experimental group

Description:

This is the second study group where patients undergo extractions with the presumably minimally invasive Physics forceps.

Treatment:

Device: Physics Forceps

Procedure: Tooth extraction

Convetional extraction

Active Comparator group

Description:

This is the control group where patients undergo tooth extractions with conventional extraction forceps and elevators.

Treatment:

Device: Conventional Extraction Forceps

Procedure: Tooth extraction