NCT06881095

Brief Summary

20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation using either the immediate implant with socket shield technique or the conventional immediate dental implant. the socket shield technique group (study group): 10 patients will have immediate implant placement with the socket shield technique.

  • conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

March 25, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

March 11, 2025

Last Update Submit

March 15, 2025

Conditions

Keywords

socket shield techniquepartial extraction therapyimmediate dental implant

Outcome Measures

Primary Outcomes (2)

  • labial bone thickness

    1\. labial bone thickness measuring thickness of labial bone labial to the implant by (CBCT) Cone beam computed tomography

    6 months

  • marginal bone loss

    6 months

Secondary Outcomes (3)

  • bone density around dental implant

    6 months

  • implant secondary stability

    6 months

  • implant success

    6 months

Study Arms (2)

socket shield technique group (study group)

EXPERIMENTAL

the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique. * conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique without socket shield technique. preparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest. The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe. After completion of th

Procedure: socket shield technique group (study group)

conventional immediate implant without socket shield technique(control group)

EXPERIMENTAL

conventional immediate implant without socket shield technique: • After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw. However, the soft tissue contour formed after healing may need some modification prior to impression taking. Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months.

Procedure: conventional immediate implant without socket shield technique

Interventions

immediate implant installation with socket shield technique: After administration of local anesthesia, the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds. Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest. The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants, and the root section was checked for immobility with a sharp probe. After completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer

Also known as: partial extraction therapy
socket shield technique group (study group)

• After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw. However, the soft tissue contour formed after healing may need some modification prior to impression taking. Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months.

conventional immediate implant without socket shield technique(control group)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 1. Non restorable maxillary anterior teeth without periapical pathology that may affect the success of dental implants.
  • \. Interarch space enough for prosthetic rehabilitation. 3. Presence of posterior teeth or prosthesis that maintain occlusal bite. 4. Adult patients. 5. Good oral hygiene.

You may not qualify if:

  • \- 1. Edentulous anterior maxillary region. 2. Bad oral hygiene. 3. Patients with any relevant systemic diseases that affect soft tissue or bone healing.
  • \. Patients with parafunctional habits (bruxism and clenching). 5. Uncooperative patients. 6. Heavy smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Tanta, 3111, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

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

Study Officials

  • islam ahmed abo elela, master study

    faculty of dentistry tanta university

    PRINCIPAL INVESTIGATOR
  • Ibrahim mohammed nowair, professor

    faculty of dentistry tanta university

    PRINCIPAL INVESTIGATOR
  • Rafic ramadan bedir, professor

    faculty of dentistry tanta university

    PRINCIPAL INVESTIGATOR
  • Wesam Hamed Elsaadany, lecturer

    faculty of dentistry tanta university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: non restorable anterior teeth with thin labial plate of bone
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master degree( Principal Investigator)

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 18, 2025

Study Start

March 25, 2024

Primary Completion

May 12, 2025

Study Completion

June 16, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations