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

Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment. A 1-Year Randomized Clinical Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Immediate Implant; Esthetic Zone; Customized Healing Abutment; Tissue Collapse; Tissue Dimensional Changes
• Intervention / Treatment: Procedure: immediate implant placement with customized healing abutment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immediate implant placement with customized healing abutment	Procedure: immediate implant placement with customized healing abutment; immediate implant placement with customized healing abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of vertical crestal bone resorption in millimeters	Vertical crestal bone changes via CBCT in mm	1 year
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
amount of Mid facial recession in millimeters	Mid facial recession in n millimeters	1 year
Pink esthetic score	1-14 scale	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 10, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 10, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: IDCE.N5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No