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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06299449
Other study ID # KFSIRB200-174
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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