Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems

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.

Study Overview

• Status: Completed
• Conditions: Tooth Extraction Status Nos
• Intervention / Treatment: Procedure: Tooth extraction; Device: Benex; Device: Physics Forceps; Device: Conventional Extraction Forceps

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Pl
    • Plovdiv, Pl, Bulgaria, 4000
      • Department of Oral Surgery, Faculty of Dental Medicine, Medical University - Plovdiv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Benex tooth extraction; This is the first study group where patients undergo extractions with presumably the vertical tooth extraction system Benex.	Procedure: Tooth extraction; A regular closed tooth extraction was performed with the different devices from each arm.; Device: Benex; Benex was used to perform the intervention.
Experimental: Physics forceps extraction; This is the second study group where patients undergo extractions with the presumably minimally invasive Physics forceps.	Procedure: Tooth extraction; A regular closed tooth extraction was performed with the different devices from each arm.; Device: Physics Forceps; Physics forceps were used to perform the intervention.
Active Comparator: Convetional extraction; This is the control group where patients undergo tooth extractions with conventional extraction forceps and elevators.	Procedure: Tooth extraction; A regular closed tooth extraction was performed with the different devices from each arm.; Device: Conventional Extraction Forceps; Conventional Extraction Forceps were used to perform the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extraction success	The scale suggested by Choi was used to assess each of the extraction systems. Scored from 1 to 5. Higher is better.	From the beginning of the extraction to the completion of the procedure
Alveolar bone buccal cortical plate preservation	The difference between the height of the alveolar bone buccal cortical plate is measured before and after the tooth extraction. Scored in milimeters missing. Lower is better.	From the beginning of the extraction to the completion of the procedure
VAS pain score	Patients were asked to rate their pain experience on a visual analog scale (VAS). Measured in centimeters on 10cm line. Lower is better.	0, 1, 3, 7 day
Early wound healing	Landry's early wound healing index was used to evaluated the extraction healing process. Scores from 1 to 5. Higher is better.	3, 7, 10 day

Collaborators and Investigators

• Sponsor: Plovdiv Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DPDP02/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No