Immediate Implant Placement With Different Materials of Customized Healing Abutment for Guiding Peri-implant Soft Tissue Healing in Posterior Teeth

Cairo University (CU)

Status: Enrolling

Conditions: Peri-implant Mucositis

Treatments: Other: immediate implant placement with customized PEEK healing abutment

Study type: Interventional

Funder types: Other

Identifiers

NCT06645444

591024

Details and patient eligibility

About

: Immediate Implant Placement with different materials of customized healing abutment for guiding Peri-implant Soft Tissue Healing in Posterior Teeth: A Randomized controlled clinical trial.

Full description

This randomized clinical trial evaluates the effect of customized PEEK healing abutment versus composite healing abutment regarding Clinical evaluation

1. Gingival margin distance
2. Gingival margin height
3. Gingival contour width
4. Gingival volume in BL & MD aspects on guiding the peri- implant soft tissue emergency profile in posterior teeth after immediate implant placement

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Inclusion Criteria of participants:

  • Periodontally and systemic healthy patients
  • Patients aged > 18 years
  • Non- restored teeth for many reasons (i.e. endodontic failure, unworthy for treatment in deep caries/non-caries lesion and root fracture), locate in the posterior area in the maxillary or mandibular arch indicate for customized implant with no need for additional bone and soft tissue augmentation procedures.
  • An adequate vertical bone for immediate implant placement.
  • Implants will be positioned with adequate primary stability so that transmucosal healing can be accomplished.
  • No taken medications known to interfere healing or periodontal tissue health or bone metabolism.
  • No previous periodontal surgery at involved sites.
  • Good oral hygiene and good compliance with the plaque control instructions following initial therapy.

Exclusion criteria

• Patients with active periodontal diseases (bleeding on probing- probing depth > 4 mm) or those under orthodontic treatment.
• Poor oral hygiene (full mouth plaque score > 25% and full mouth bleeding score > 25%)
• Smoking habits (> 10 cigarettes/day)
• Severe acute or chronic periodontitis
• Severe bruxism habits
• History of oral/IV bisphosphonates taking
• Remote or recent radiation therapy in the oro-maxillo-facial area or recent chemotherapy.
• Xerostomia
• Pregnant and lactating mothers
• Patients who have been received periodontal surgery in the study area during the last year.
• Clinical or radiographic signs of periapical pathology contraindicating immediate implant placement.
• Implants showing signs of peri-implant mucositis and peri-implantitis during the study period will be excluded from the following analyses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

immediate implant placement with customized composite healing abutment

Active Comparator group

Description:

* extraction of the Posterior teeth will be done with minimally invasive technique using periotome. * Then, the digital surgical guide will be placed, and will be checked the affinity of the reference window with other teeth accurately in the optimal position. The osteotomies will be prepared with a surgical-guided surgery kit through a digital surgical guide and drill direction will be ensured by radiographic taking. Implant fixture insertion will be performed through this digital surgical guide. * All patients will receive a bone-level implant with varying diameter and length in each case. After implant placement, the operator will scan the surrounding gingiva with a scan body immediately for a post-extraction digital model. * Then the spaces between the implant fixture and alveolar bone wall will be filled with locally harvested autogenous bone and xenograft grafting material (OsteoBiol Gen-Os, Sweden).

Treatment:

Other: immediate implant placement with customized PEEK healing abutment

immediate implant placement with customized PEEK healing abutment

Experimental group

Description:

* an intraoral examination will be done and a digital impression will be taken by the intraoral scanner (MEDIT i500) for a pre-extraction digital model, and CBCT will be taken for prosthetic-driven planning. * Once the treatment plan formulated, both STL (Standard Triangle Language) and DICOM (CBCT raw data) files format will be sent to produce the digital surgical guide with metal sleeve. * Then, a customized PEEK healing abutment will be made mimicking the anatomical cervical contour and pseudo-CEJ will be made by merging the STL and DICOM digitally and the exterior surface of the healing abutment will be designed to resemble a tooth. * Then, the technicians will mill the customized healing abutment digital design from a pre-milled 14 × 14 mm PEEK block (BioHPP, Bredent®, Bolzano, Italy) with a non-hex connection type, polished it, and sterilized it. * The digital surgical guide with a metal sleeve will be back for scheduled patient implant surgery.

Treatment:

Other: immediate implant placement with customized PEEK healing abutment