NCT05658419

Brief Summary

immediate implant placement versus socket shield approach

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

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 14, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

December 12, 2022

Last Update Submit

December 12, 2022

Conditions

Keywords

socket shield

Outcome Measures

Primary Outcomes (1)

  • radiographic bone level

    vertical and horizontal bone loss

    6 months

Study Arms (2)

control group

ACTIVE COMPARATOR

immediate implant placement

Procedure: socket sheild

study group

ACTIVE COMPARATOR

socket shield immediate implant placement

Procedure: socket sheild

Interventions

socket sheildPROCEDURE

the socket shield technique, in which a partial root fragment was retained around an immediately placed implant with the aim of avoiding tissue alterations after tooth extraction. Histologic evaluation in a beagle dog showed no resorption of the root fragment and new cementum formed on the implant surface.

Also known as: partial extraction therapies
control groupstudy group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of 20-45 years of both sexes. Good oral hygiene Demonstrating non-restorable maxillary anterior single rooted teeth in the esthetic zone with as far diagnosable.
  • Fairly intact buccal periodontal tissues. Patients' acceptance to sign the informed consent. Labial bone plates less than 1.5 mm in thickness or cases with labial root curvatures.
  • Intact root with no mobility in the tooth and no sub-gingival caries.

You may not qualify if:

  • Patients with systemic diseases that would interfere with the normal healing such as uncontrolled diabetes mellitus.
  • History of radiation therapy to the head and neck. No history of bruxism/ para-functional habits. (119) Teeth with periodontal disease, vertical root fracture, horizontal fracture at or below the bone level, and teeth with local pathologic incidents that affect the labial part of the root as external or internal root resorption were also excluded.
  • Maxillary 1st and 2nd premolars. Pregnant and lactating females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Mohamed Shehata Elsayed

Alexandria, 21516, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Operator Data collector Examiner
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Study group (socket shield) vs. Control group (immediate implants)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 20, 2022

Study Start

January 14, 2021

Primary Completion

December 1, 2021

Study Completion

August 5, 2022

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations