Skip to main content
Clinical Trials/NCT05276765
NCT05276765
Unknown
Not Applicable

Peri-implant Soft Tissue Conditioning of Immediate Posterior Implants by CAD/CAM Socket Sealing Abutments (A Randomized Controlled Clinical Trial)

Cairo University1 site in 1 country22 target enrollmentApril 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Implant Site Reaction
Sponsor
Cairo University
Enrollment
22
Locations
1
Primary Endpoint
Pink esthetic score
Last Updated
4 years ago

Overview

Brief Summary

One of the major challenges one clinician can face while performing immediate placement on posterior area, is the ability of obtaining a hermetic primary closure of the soft tissue. The use of socket sealing abutment may provide advantages in maintaining the existing soft tissue architecture, preserving crestal bone height and reducing the risk of premature loading of the immediate implant during healing

Detailed Description

One of the major challenges one clinician can face while performing immediate placement on posterior area, is the ability of obtaining a hermetic primary closure of the soft tissue. This technical skill is nearly always combined with invasive surgical procedures and significant post op recovery (displacement of the muco-gingival line, periosteal releasing incision, flaps, sutures, membrane stabilization, ...).the use of customized healing abutment may provide advantages in maintaining the existing soft tissue architecture, preserving crestal bone height and reducing the risk of premature loading of the immediate implant during healing. Moreover, customized healing abutment can passively accommodate the definitive prosthesis with minimal or no pressure placement preventing biological or mechanical trauma during the prosthetic phases. This may lead to better long-term tissue stability and avoid the pain perceived by the patients from compression of tissues in case of standard healing abutment. the primary aim of this randomized controlled clinical study is to clinically evaluate and compare the soft tissue outcomes of final immediate implant restorations placed in maxillary posterior sites that were conditioned by CAD/CAM fabricated socket sealing abutments versus standard healing abutments. The secondary aim of this study is to radiographically assess peri-implant bone level changes of the final immediate implant restorations placed in maxillary posterior sites for the two experimental groups.

Registry
clinicaltrials.gov
Start Date
April 2022
End Date
December 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mai Elgendi

assistant lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

  • The patients ≥18 years old.
  • Non-restorable maxillary posterior teeth with intact adjacent teeth.
  • Sufficient bone to insert a dental implant with a minimum length of 8 mm and at least 3.5 mm in diameter.
  • Type1 extraction socket according to Elian et al, 200742 (Labial bone plate and associated soft tissues are completely intact).
  • Sufficient mesio-distal, bucco-lingual, and inter-occlusal space for placement of the definite restoration.
  • Adequate oral hygiene (full mouth plaque score \< 25% and full mouth bleeding score \< 25%).
  • Patients capable of understanding and giving informed consent.

Exclusion Criteria

  • Alcohol or drug abusers.
  • Heavy smokers (\> 10 cigarettes/day).
  • Presence of acute periapical infections.
  • Radiotherapy to the head and neck region for malignancy.
  • Bruxism or TMJ dysfunction.
  • Intake of drugs affecting bone metabolism.
  • Uncontrolled diabetic patients.
  • Pregnant women.

Outcomes

Primary Outcomes

Pink esthetic score

Time Frame: one year of follow up

clinical evaluation of soft tissue profile around the implant restorations with minimum score of 0 and maximum score of 10

Secondary Outcomes

  • Functional implant prosthodontic score(one year of follow up)

Study Sites (1)

Loading locations...

Similar Trials