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

Immediate Implant Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06040788
• Other study ID #: IDCE.N5
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: November 2024

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Immediate Implant
• Shock

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of labiopalatal ridge collapse	radiographic Labiopalatal ridge collapse via CBCT	1 year
Primary	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	Amount of vertical crestal bone resorption in millimeters	Vertical crestal bone changes via CBCT in mm	1 year
Secondary	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
Secondary	amount of Mid facial recession in millimeters	Mid facial recession in n millimeters	1 year
Secondary	Pink esthetic score	1-14 scale	1 year