Status unknownNCT06040788Updated Sep 18, 2023

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

An interventional study of immediate implant placement with customized healing abutment in Immediate Implant, Esthetic Zone and Customized Healing Abutment, sponsored by Cairo University. Status unknown. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Not applicable
Ages: 21 Years to 65 Years
Sex: All

Study 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 studied

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

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 60 participants (estimated)

Study arms

Experimental
immediate implant placement with customized healing abutment
Procedure: immediate implant placement with customized healing abutment

Interventions

Procedureimmediate implant placement with customized healing abutment
immediate implant placement with customized healing abutment

What researchers measure

Primary outcomes

Amount of labiopalatal ridge collapse
radiographic Labiopalatal ridge collapse via CBCT
Time frame: 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
Time frame: 1 year

Secondary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06040788
Lead sponsor: Cairo University
Responsible party: Nesma Mohamed Fouad Shemais (Lecturer in the department of Oral Medicine & Periodontology, Cairo University) — Principal investigator
First posted: Sep 18, 2023
Start date: Sep 2023 (estimated)
Primary completion: Sep 2024 (estimated)
Completion: Nov 2024 (estimated)
Last update: Sep 18, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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