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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06040788
Other study ID # IDCE.N5
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date November 2024

Study information

Verified date September 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to investigate the effect of different anatomical variations in terms of root angulation, alveolar bone and basal bone morphology on soft and hard tissue alterations in patients with non-restorable teeth in the inter-canine region undergoing immediate implantation. The main question it aims to answer are: - Will the amount of collapse be greater when the root is proclined or outside the bone housing? - Will no additional intervention be needed with immediate implants in the esthetic zone if we have better anatomy that will help hinder the collapse? Participants will receive immediate dental implants with customized healing abutments


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: Patient-related criteria: - Adults at or above the age of 21. - Non-restorable maxillary inter-canine tooth requiring extraction and needed an implant placing therapy. - The failing tooth will have adjacent and opposing natural teeth. - Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration. - Able to tolerate surgical periodontal procedures. - Good oral hygiene. - Compliance with the maintenance program. - Provide informed consent. - Accepts the one-year follow-up period. Teeth related criteria: - Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue. - Intact socket wall before the extraction, buccal bone thickness =1mm assessed by CBCT. - Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm. Exclusion criteria: - Patients diagnosed with periodontal diseases. - Current or previous smokers. - Pregnant and lactating females. - Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis. - Patients with active infection related at the site of implant/bone graft placement. - Patients with parafunctional habits

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
immediate implant placement with customized healing abutment
immediate implant placement with customized healing abutment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of labiopalatal ridge collapse radiographic Labiopalatal ridge collapse via CBCT 1 year
Primary Amount of bone labial to the implant Amount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT 1 year
Secondary Amount of vertical crestal bone resorption in millimeters Vertical crestal bone changes via CBCT in mm 1 year
Secondary Amount of change in buccal soft issue contour in mm3 volumetric analysis of the amount of change in buccal soft issue contour in mm3 1 year
Secondary amount of Mid facial recession in millimeters Mid facial recession in n millimeters 1 year
Secondary Pink esthetic score 1-14 scale 1 year
See also
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Active, not recruiting NCT06241196 - Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft Phase 2
Not yet recruiting NCT05431998 - Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone. N/A
Completed NCT04731545 - Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone N/A
Completed NCT05878392 - Immediate Implant With Different Filling Materials N/A