Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement

Dental Implant Failed Clinical Trial

Official title:

Clinical and Radiographic Outcomes of Computer Guided Immediate Implant Placement Utilizing Artificial Intelligence Assisted Socket Shield Approach: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299449
• Other study ID #: KFSIRB200-174
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: March 20, 2025

Study information

• Verified date: March 2024
• Source: Kafrelsheikh University
• Contact: Walid AH Elamrousy, PhD
• Phone: +201091444946
• Email: waled_hammed[@]den.kfs.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.

Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: March 20, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• above the age of 18years

• presence of non-restorable maxillary anterior tooth

• had intact socket walls following tooth extraction

• the gingival biotype was thick.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dental Implant Failed
• Implant Complication

Intervention

Procedure:
• free-hand socket shield
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
• AI/guided socket shield
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

Locations

Country	Name	City	State
Egypt	faculty of dentistry, kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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