NCT06299449

Brief Summary

Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

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

First Submitted

Initial submission to the registry

March 1, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

March 1, 2024

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Stability Quotient of dental implant

    Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, investigators now know that high stability means \>70 ISQ, between 60-69 is medium stability and \< 60 ISQ is considered as low stability

    9-month.

  • pink esthetic score

    The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14

    9-month.

  • Midfacial Mucosal Alterations

    digital intraoral scans were recorded. To quantify the vertical changes in the soft tissues around implants buccally, the collected scans were digitally superimposed via matching Gom inspect software

    9-month.

  • facial marginal bone level

    Utilizing CBCT sagittal sections, the BMBL was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.

    9-month

Study Arms (2)

control group

EXPERIMENTAL

conventional socket shield with conventional simultaneous implant placement

Procedure: free-hand socket shield

study group

EXPERIMENTAL

computer guided implant placement combined with artificial intelligence-assisted socket shield.

Procedure: AI/guided socket shield

Interventions

Immediate Implant Placement Using Socket Shield Technique with autogenous whole tooth graft after immediate implantation using Socket Shield Technique, the palatal root portion and the decoronated crown will be converted to autogenous whole tooth graft and used for grafting the defect between the socket shield and the implant fixture

Also known as: Elamrousy Novel Approach of Socket Shield Technique
control group

The patient specific guides will be placed at the pre-planned positions at the labial buccal mucosa. using artificial intelligence the socket shield approach will be planned to keep the buccal shield and using surgical guide the shield will be preciesly prepared followed by guided implant placement and whole tooth grafting of the jumping gap

Also known as: AI/guided Elamrousy Novel Approach of Socket Shield Technique
study group

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • above the age of 18years
  • presence of non-restorable maxillary anterior tooth
  • had intact socket walls following tooth extraction
  • the gingival biotype was thick.

You may not qualify if:

  • history of systemic condition
  • history of using bisphosphonates or other drugs that might impact bone turnover
  • a history of smoking during the previous five years,
  • a history of any acute infections at the surgical site,
  • teeth having root resorptions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

Study Officials

  • Walid AH Elamrousy, PhD

    Faculty of Oral and Dental Medicine, Kafrelsheikh University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of periodontology

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

March 5, 2024

Primary Completion

September 17, 2025

Study Completion

October 26, 2025

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

the new approach of using artificial intelligence to assist in the planning of socket shield technique will not be shared

Locations