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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06040788
Enrollment
60
Registered
2023-09-18
Start date
2023-09-30
Completion date
2024-11-30
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

immediate implant placement with customized healing abutment

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Amount of labiopalatal ridge collapse1 yearradiographic Labiopalatal ridge collapse via CBCT
Amount of bone labial to the implant1 yearAmount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT

Secondary

MeasureTime frameDescription
Amount of vertical crestal bone resorption in millimeters1 yearVertical crestal bone changes via CBCT in mm
Amount of change in buccal soft issue contour in mm31 yearvolumetric analysis of the amount of change in buccal soft issue contour in mm3
amount of Mid facial recession in millimeters1 yearMid facial recession in n millimeters
Pink esthetic score1 year1-14 scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026