Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment

Not Applicable

Not yet recruiting

• Conditions: Tissue Collapse; Customized Healing Abutment; Tissue Dimensional Changes; Esthetic Zone; Immediate Implant
• Interventions: Procedure: immediate implant placement with customized healing abutment

• Registration Number: NCT06040788
• Lead Sponsor: Cairo University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-10
• Last Update Submitted: 2023-09-10
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-09
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immediate implant placement with customized healing abutment	immediate implant placement with customized healing abutment	-

Primary Outcome Measures

Name	Time	Method
Amount of labiopalatal ridge collapse	1 year	radiographic Labiopalatal ridge collapse via CBCT
Amount of bone labial to the implant	1 year	Amount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT

Secondary Outcome Measures

Name	Time	Method
Amount of vertical crestal bone resorption in millimeters	1 year	Vertical crestal bone changes via CBCT in mm
Pink esthetic score	1 year	1-14 scale
Amount of change in buccal soft issue contour in mm3	1 year	volumetric analysis of the amount of change in buccal soft issue contour in mm3
amount of Mid facial recession in millimeters	1 year	Mid facial recession in n millimeters