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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: the Main Focus of the Study is to Use Socket Sealing Abutment in Conditioning of the Soft Tissue After Immediate Implant Placement
• Intervention / Treatment: Procedure: cad/cam socket sealing abutment; Procedure: standard healing abutment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mai elgendi, master; Phone Number: +201126811001; Email: mai.eltohami@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PES (pink esthetic score)	clinical evaluation of soft tissue profile around the implant restorations	one year of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FIPS(Functional implant prosthodontic score)	clinical evaluation of implant restoration assembly and radiographic crestal bone loss	one year of follow up

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 11122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No