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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06040788
Collaborator
(none)
60
1
14

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: immediate implant placement with customized healing abutment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Amount of labiopalatal ridge collapse [1 year]

    radiographic Labiopalatal ridge collapse via CBCT

  2. 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

  1. Amount of vertical crestal bone resorption in millimeters [1 year]

    Vertical crestal bone changes via CBCT in mm

  2. 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

  3. amount of Mid facial recession in millimeters [1 year]

    Mid facial recession in n millimeters

  4. Pink esthetic score [1 year]

    1-14 scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nesma Mohamed Fouad Shemais, Lecturer in the department of Oral Medicine & Periodontology, Cairo University
ClinicalTrials.gov Identifier:
NCT06040788
Other Study ID Numbers:
  • IDCE.N5
First Posted:
Sep 18, 2023
Last Update Posted:
Sep 18, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 18, 2023