Clinical trial NCT06040788: Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Immediate Implant
Esthetic Zone
Customized Healing Abutment
Tissue Collapse
Tissue Dimensional Changes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Amount of labiopalatal ridge collapse
timeFrame: 1 year
measure: Amount of bone labial to the implant
timeFrame: 1 year
Secondary outcomes:
measure: Amount of vertical crestal bone resorption in millimeters
timeFrame: 1 year
measure: Amount of change in buccal soft issue contour in mm3
timeFrame: 1 year
measure: amount of Mid facial recession in millimeters
timeFrame: 1 year
measure: Pink esthetic score
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: