NCT06496906

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
Last Updated

July 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

June 26, 2024

Last Update Submit

July 3, 2024

Conditions

Tooth Extraction Status Nos

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (3)

Benex tooth extraction

EXPERIMENTAL

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

Procedure: Tooth extractionDevice: Benex

Physics forceps extraction

EXPERIMENTAL

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

Procedure: Tooth extractionDevice: Physics Forceps

Convetional extraction

ACTIVE COMPARATOR

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

Procedure: Tooth extractionDevice: Conventional Extraction Forceps

Interventions

Tooth extractionPROCEDURE

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

Benex tooth extractionConvetional extractionPhysics forceps extraction
BenexDEVICE

Benex was used to perform the intervention.

Benex tooth extraction
Physics ForcepsDEVICE

Physics forceps were used to perform the intervention.

Physics forceps extraction
Conventional Extraction ForcepsDEVICE

Conventional Extraction Forceps were used to perform the intervention.

Convetional extraction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Plovdiv, Pl, 4000, Bulgaria

Location

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 11, 2024

Study Start

September 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

July 11, 2024

Record last verified: 2024-06

Locations

BU(1)