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OpenTrials
Completed

NCT Number: NCT06496906

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.

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Key information

Conditions

Tooth Extraction Status Nos

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral Surgery, Faculty of Dental Medicine, Medical University - Plovdiv

Plovdiv, Pl, 4000, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tooth extraction

Procedure

A regular closed tooth extraction was performed with the different devices from each arm.

Benex

Device

Benex was used to perform the intervention.

Physics Forceps

Device

Physics forceps were used to perform the intervention.

Conventional Extraction Forceps

Device

Conventional Extraction Forceps were used to perform the intervention.

Primary outcomes

  1. Extraction success

    Time frame: From the beginning of the extraction to the completion of the procedure

    The scale suggested by Choi was used to assess each of the extraction systems.

    Scored from 1 to 5. Higher is better.

  2. Alveolar bone buccal cortical plate preservation

    Time frame: From the beginning of the extraction to the completion of the procedure

    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.

  3. VAS pain score

    Time frame: 0, 1, 3, 7 day

    Patients were asked to rate their pain experience on a visual analog scale (VAS).

    Measured in centimeters on 10cm line. Lower is better.

  4. Early wound healing

    Time frame: 3, 7, 10 day

    Landry's early wound healing index was used to evaluated the extraction healing process.

    Scores from 1 to 5. Higher is better.

Sponsors and collaborators

Lead sponsor

Plovdiv Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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