NCT04101552

Brief Summary

Many techniques have been proposed to prevent or rather minimize the labial bone resorption following extraction including guided bone regeneration techniques that has been attempted for many years now to preserve the alveolar ridge dimensions . Immediate implant placement, flapless implant placement, palataly positioned implants and even platform switching. However none of these methods were able to completely preserve the coronal part of the facial bone wall, and since the main reason of bone loss following extraction is the loss of the periodontal ligament, it seemed logical that root retention may affect the resorption process,The reason the root retention technique works in its different applications is due to the maintenance of the periodontal attachment including cementum, periodontal ligaments and bundle bone, this principle was used by Hurzeler in 2010 in a technique called socket shied technique.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Status
unknown

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

September 20, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

September 22, 2019

Last Update Submit

September 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Marginal bone loss

    Will be measured using linear measurements from CBCT

    • Amount of bone loss will be measured after 6 month using linear measurement from CBCT

Secondary Outcomes (1)

  • secondary stability

    will be measured intraoperative and 3 months after surgery

Other Outcomes (1)

  • pink esthetic score

    Pink esthetics will be measured using pink esthetic index chart After 6 months.

Study Arms (1)

grafted versus graft less socket shield technique

EXPERIMENTAL
Procedure: socket shield technique with xenophobic graft particulate and without the use of graft

Interventions

the jumping gap between the implant and the shield is grafted by xenograft particulate and the control group is not grafted

grafted versus graft less socket shield technique

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.
  • Uncontrolled diabetic patients.
  • Pregnant patients.
  • Teeth with Large pulpal pathosis as cysts, large periapical granulomas
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Immunodeficiency pathology, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
  • Psychiatric problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Fractures

Interventions

Immediate Dental Implant Loading

Condition Hierarchy (Ancestors)

Tooth InjuriesTooth DiseasesStomatognathic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Poosy H. Mohamed, principal investigator

CONTACT

Mohamed A. Abdelrasoul, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 22, 2019

First Posted

September 24, 2019

Study Start

September 20, 2019

Primary Completion

February 20, 2020

Study Completion

August 20, 2020

Last Updated

September 24, 2019

Record last verified: 2019-09