Peri-implant Soft Tissue Conditioning of Immediate Posterior Implants by CAD/CAM Socket Sealing Abutments

NCT05276765 | Completed DMC

• 1 other identifier: 11122
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Implant Site Reaction

Keywords

immediate posterior implants, socket sealing abutments

Outcome Measures

Primary Outcomes (1)

• Pink esthetic score

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

  one year of follow up

Secondary Outcomes (1)

• Functional implant prosthodontic score

  one year of follow up

Study Arms (2)

CAD/CAM customized Socket Sealing Abutment

EXPERIMENTAL

Anatomically formed healing abutments that can solve many of the problems inherent to immediate posterior implant placement and to optimize the conditioning of supra implant tissue architecture enhancing the emergence profile of the final implant restoration

Procedure: cad/cam socket sealing abutment

Standard healing abutment

ACTIVE COMPARATOR

Standard healing abutment will be inserted after removal of cover screw after immediate implant insertion and then a muco-periosteal flap will be reflected for the primary closure of the socket and sutured around the standard healing abutment.

Procedure: standard healing abutment

Interventions

cad/cam socket sealing abutment PROCEDURE

Anatomically formed healing abutments that can solve many of the problems inherent to immediate posterior implant placement and to optimize the conditioning of supra implant tissue architecture enhancing the emergence profile of the final implant restoration

CAD/CAM customized Socket Sealing Abutment

standard healing abutment PROCEDURE

Standard healing abutment will be inserted after removal of cover screw after immediate implant insertion and then a muco-periosteal flap will be reflected for the primary closure of the socket and sutured around the standard healing abutment.

Standard healing abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The patients ≥18 years old. 2. Non-restorable maxillary posterior teeth with intact adjacent teeth. 3. 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.

You may not qualify if:

• \. Alcohol or drug abusers. 2. Heavy smokers (\> 10 cigarettes/day). 3. Presence of acute periapical infections. 4. Radiotherapy to the head and neck region for malignancy. 5. Bruxism or TMJ dysfunction. 6. Intake of drugs affecting bone metabolism. 7. Uncontrolled diabetic patients. 8. Pregnant women.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12278, Egypt

Location

Related Publications (1)

• Elgendi MM, Hamdy ISE, Sallam HI. Peri-implant soft tissue conditioning of immediate posterior implants by CAD-CAM socket sealing abutments: a randomized clinical trial. BMC Oral Health. 2025 Jan 17;25(1):83. doi: 10.1186/s12903-024-05417-w.

  PMID: 39819325 DERIVED

Study Officials

• Amina Zaki, PhD degree

  Professor in Fixed Prosthodontics department, Faculty of Dentistry, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 11, 2022
• Study Start: August 3, 2022
• Primary Completion: February 4, 2024
• Study Completion: March 17, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)