NCT04930497

Brief Summary

Management of the jumping gap in the Vestibular Socket Therapy. And to study what is the best technique to manage this gap for optimal esthetic result.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

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

November 20, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

June 11, 2021

Last Update Submit

July 17, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Facial bone thickness

    using CBCT scans (Carestream 8000D, Carestream Dental)

    baseline, 6 months and 13 months

  • Change in Facial bone height

    using CBCT scans (Carestream 8000D, Carestream Dental)

    baseline, 6 months and 13 months

Study Arms (2)

vestibular socket technique with bone grafting

EXPERIMENTAL
Procedure: vestibular socket technique with bone grafting

vestibular socket technique without bone grafting

ACTIVE COMPARATOR
Procedure: vestibular socket technique without bone grafting

Interventions

a vestibular horizontal incision was made then a subperiosteal tunnel was created and a facial bone membrane was placed. The facial gap was filled with a mixture of autogenous bone and deproteinized bovine bone mineral

vestibular socket technique with bone grafting

the vestibular incision was done horizontally about 3 to 4 mm apical to the mucogingival junction and extending 5 to 10 mm horizontally. A submucoperiosteal tunnel was created labially from the socket orifice till the vestibular access incision

vestibular socket technique without bone grafting

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • presence of a hopeless tooth or teeth in the esthetic zone (maxillary anterior area)
  • No active infection
  • Adequate bone palatally and apically
  • Presence of contralateral tooth for the tooth being replaced

You may not qualify if:

  • Hopeless tooth with acute infection
  • heavy smokers (more than 10 cigarettes per day)
  • pregnant and patients received recent chemotherapy/radiotherapy (during the previous year)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Practice Clinic

Alexandria, Egypt

Location

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

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

June 11, 2021

First Posted

June 18, 2021

Study Start

November 20, 2019

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations