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

NCT ID: NCT06040788

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

immediate implant placement with customized healing abutment

Group Type: EXPERIMENTAL

immediate implant placement with customized healing abutment

Intervention Type: PROCEDURE

immediate implant placement with customized healing abutment

Interventions

immediate implant placement with customized healing abutment

immediate implant placement with customized healing abutment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Mohamed Fouad Shemais

Lecturer in the department of Oral Medicine & Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IDCE.N5

Identifier Type: -

Identifier Source: org_study_id