NCT05112796

Brief Summary

The current randomized clinical trial aimed to compare the VST versus Partial Extraction Therapy (PET) for immediate implant placement in the esthetic zone in class I fresh extraction sites. The primary outcome was the assessment of vertical dimensional changes in peri-implant soft tissue margin. The secondary outcome was the assessment of radiographic changes in the thickness of the facial peri-implant tissues.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
Last Updated

November 9, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

October 29, 2021

Last Update Submit

October 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in the peri-implant facial tissue thickness

    through CBCT images (Carestream 8000D- Carestream Dental) that were taken at baseline and 6 months postoperatively

    at baseline and 6 months

Study Arms (2)

VST technique

EXPERIMENTAL
Procedure: Class I extractions sites received immediate implants using the Vestibular Socket Therapy

PET technique

ACTIVE COMPARATOR
Procedure: class I extractions sites received immediate implants using the Partial Extraction Therapy

Interventions

A 1-cm-long vestibular access incision was made using a 15c blade 3 to 4 mm apical to the mucogingival junction at the related socket. A subperiosteal tunnel was created connecting the socket orifice and the vestibular access incision

VST technique

the hopeless tooth was decoronated 1 mm coronal to the gingival margin using a diamond bur. Then, the facial root segment was separated from the rest of the root using a Lindemann bur in gentle mesiodistal sweeping strokes from the gingival margin to the apex of the root, aiming to separate the palatal and the labial root segments.

PET technique

Eligibility Criteria

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

You may qualify if:

  • single hopeless maxillary tooth in the esthetic zone
  • non-smokers
  • systemically healthy
  • Class I extraction sites

You may not qualify if:

  • smoking
  • Class II and III extraction sites
  • hopeless teeth with acute infection or vertical/horizontal root fracture

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
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 9, 2021

Study Start

January 1, 2020

Primary Completion

March 24, 2021

Study Completion

March 24, 2021

Last Updated

November 9, 2021

Record last verified: 2021-10

Locations