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

NCT06040788 | Unknown

• 1 other identifier: IDCE.N5
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Immediate Implant; Esthetic Zone; Customized Healing Abutment; Tissue Collapse; Tissue Dimensional Changes

Outcome Measures

Primary Outcomes (2)

• Amount of labiopalatal ridge collapse

  radiographic Labiopalatal ridge collapse via CBCT

  1 year

• 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 Outcomes (4)

• Amount of vertical crestal bone resorption in millimeters

  1 year

• Amount of change in buccal soft issue contour in mm3

  1 year

• amount of Mid facial recession in millimeters

  1 year

• Pink esthetic score

  1 year

Study Arms (1)

immediate implant placement with customized healing abutment

EXPERIMENTAL

Procedure: immediate implant placement with customized healing abutment

Interventions

immediate implant placement with customized healing abutment PROCEDURE

immediate implant placement with customized healing abutment

immediate implant placement with customized healing abutment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in the department of Oral Medicine & Periodontology

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 18, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-09