NCT04990999

Brief Summary

study proposes an alternative atraumatic tooth extraction procedure; Apically achieved exodontia, which might offer an alternative to the conventional incisal exodontia, whilst providing minimum tissue trauma and subsequently maximum marginal tissue preservation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

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

April 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

July 26, 2021

Last Update Submit

August 3, 2021

Conditions

Tooth Extraction

Outcome Measures

Primary Outcomes (1)

  • Changes in post restorative soft tissue height

    identified midfacially and at the apex of the mesial and distal papillae by superimposing the STL (Standard Triangle Language) files of the models, obtained via IOS

    at baseline and 12 months

Study Arms (2)

Vestibular Root Extraction

EXPERIMENTAL
Procedure: Vestibular Root Extraction

Atraumatic extractions using periotomes followed by conventional forceps

ACTIVE COMPARATOR
Procedure: Atraumatic extractions using periotomes followed by conventional forceps

Interventions

Vestibular Root ExtractionPROCEDURE

a 1-cm long vestibular access incision was cut, 3-4 mm apical to the mucogingival junction of the involved tooth, then pushing the vestibular pouch in an incisal direction exposing the apical root area, and allowing direct undisturbed access to the root surface

Vestibular Root Extraction
Atraumatic extractions using periotomes followed by conventional forcepsPROCEDURE

a sulcular releasing incision suing a micro scalpel was made to detach the surrounding tissues, followed by applying the periotome interproximally into the PDL space, widening the attached periodontal ligaments space.

Atraumatic extractions using periotomes followed by conventional forceps

Eligibility Criteria

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

You may qualify if:

  • Single non-adjacent hopeless maxillary anterior teeth
  • Type II socket)
  • Intact overlying soft tissues.
  • Adequate palatal and at least 3 mm apical bone

You may not qualify if:

  • Smokers
  • Pregnant females
  • Patients with systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Practice Clinic

Alexandria, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 5, 2021

Study Start

April 1, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Locations

EG(1)