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

NCT ID: NCT05276765

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2024-03-17

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.

Conditions

Implant Site Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CAD/CAM customized Socket Sealing Abutment

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

Group Type: EXPERIMENTAL

cad/cam socket sealing abutment

Intervention Type: 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

Standard healing abutment

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.

Group Type: ACTIVE_COMPARATOR

standard healing abutment

Intervention Type: 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.

Interventions

cad/cam socket sealing abutment

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

Intervention Type: PROCEDURE

standard healing abutment

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1. 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.

4. Type1 extraction socket according to Elian et al, 200742 (Labial bone plate and associated soft tissues are completely intact).

5. Sufficient mesio-distal, bucco-lingual, and inter-occlusal space for placement of the definite restoration.

6. Adequate oral hygiene (full mouth plaque score < 25% and full mouth bleeding score < 25%).

7. Patients capable of understanding and giving informed consent.

Exclusion Criteria

• 1. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mai Elgendi

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amina Zaki, PhD degree

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 39819325 (View on PubMed)

Other Identifiers

11122

Identifier Type: -

Identifier Source: org_study_id