Implants: Immediate Implant vs.Socket Shield Technique in Esthetic Zone

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT05658419

Collaborator

(none)

Enrollment

Location

Arms

18.7

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

immediate implant placement versus socket shield approach

Condition or Disease	Intervention/Treatment	Phase
Bone Loss	Procedure: socket sheild	N/A

Detailed Description

This study was a randomized controlled clinical trial; patients were randomly allocated to two groups: the study group: ten dental implants were placed in the maxillary esthetic zone, implants were placed using the socket shield technique with immediate loading; and the control group: ten implants were placed immediately with immediate loading. Preoperative and 6 months postoperative CBCT were performed for both groups to assess the dimensional changes in the labial bone plates. Implant stability quotients (ISQs), pink esthetic scores and attachment loss were measured at the time of implant placement and 6 months postoperatively.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study group (socket shield) vs. Control group (immediate implants)Study group (socket shield) vs. Control group (immediate implants)

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Operator Data collector Examiner

Primary Purpose:

Other

Official Title:

Evaluation of Immediate Loaded Implants Placed Using the Socket Shield Technique in the Esthetic Zone

Actual Study Start Date :

Jan 14, 2021

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Aug 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group immediate implant placement	Procedure: socket sheild 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. Other Names: partial extraction therapies
Active Comparator: study group socket shield immediate implant placement	Procedure: socket sheild 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. Other Names: partial extraction therapies

Arm

Intervention/Treatment

Active Comparator: control group

immediate implant placement

Procedure: socket sheild

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.

Other Names:

partial extraction therapies

Active Comparator: study group

socket shield immediate implant placement

Procedure: socket sheild

Other Names:

partial extraction therapies

Outcome Measures

Primary Outcome Measures

radiographic bone level [6 months]
vertical and horizontal bone loss

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohamed Mohamed Shehata Elsayed	Alexandria		Egypt	21516

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexandria University

ClinicalTrials.gov Identifier:

NCT05658419

Other Study ID Numbers:

1103701#

First Posted:

Dec 20, 2022

Last Update Posted:

Dec 20, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alexandria University

socket shield

Study Results

No Results Posted as of Dec 20, 2022