NCT03587597

Brief Summary

eighteen implants will be placed in patients with non-restorable maxillary teeth in the aesthetic area.the recruited patients will be divided into two groups .group 1 will undergo socket shield technique with immediate temporization ,while group 2 will undergo conventional immediate implant placement with immediate temporization. to compare bone loss and aesthetic outcomes in the two techniques.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

June 9, 2018

Last Update Submit

February 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • implant stability

    implant stability will be measured using osstell device

    immediately after implant placement

Secondary Outcomes (1)

  • Amount of bone loss

    after 3 month from implant insertion.

Other Outcomes (1)

  • pink aesthetic score

    immediately after implant placement and three month later

Study Arms (2)

socket shield technique

EXPERIMENTAL

socket shield technique with immediate temporization

Procedure: socket shield technique

conventional immediate implant

ACTIVE COMPARATOR

conventional implant placement with immediate temporization

Procedure: conventional immediate implant placement with immediate temporization

Interventions

socket shield technique with immediate temporization

socket shield technique

conventional immediate implant placement with immediate temporization

conventional immediate implant

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

You may not qualify if:

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Central Study Contacts

Ahmed Abd El Rahman, BDS

CONTACT

fatma el zahraa, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 9, 2018

First Posted

July 16, 2018

Study Start

May 15, 2019

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations