Clinical trial NCT05276765: Peri-implant Soft Tissue Conditioning of Immediate Posterior Implants by CAD/CAM Socket Sealing Abutments
Official title: Peri-implant Soft Tissue Conditioning of Immediate Posterior Implants by CAD/CAM Socket Sealing Abutments (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Site Reaction
Keywords: immediate posterior implants, socket sealing abutments
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pink esthetic score
timeFrame: one year of follow up
Secondary outcomes:
measure: Functional implant prosthodontic score
timeFrame: one year of follow up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Professor in Fixed Prosthodontics department, Faculty of Dentistry, Cairo University
name: Amina Zaki, PhD degree
role: PRINCIPAL_INVESTIGATOR
References: