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

NCT06645444 | Recruiting

• 1 other identifier: 591024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

: 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.

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (4)

• Gingival margin distance

  The gingival margin distance will be measured from the highest gingival margin point in the buccal, palatal/lingual, mesial, and distal sides to the longitudinal implant line parallelly with the platform plane (buccal margin distance; BD, palatal/lingual margin distance; LD, mesial margin distance; MD and distal margin distance; DD).

  Day 0 - month 3

• Gingival margin height

  Gingival margin height will be measured from the highest gingival margin point in the buccal, lingual, mesial, and distal sides perpendicular to the platform plane (buccal height; BH, palatal/lingual height; LH, mesial height; MH and distal height; DH).

  Day 0 - month 3

• Gingival contour width

  The contour width will be measured from the outer sur face on the buccal and lingual sides to the implant center on the platform plane (buccal width; BW and palatal/lingual width; LW).

  Day 0 - month 3

• Gingival volume in BL & MD aspects

  Gingival volume will be measured on the gingiva above the platform plane for total gingival volume and separated with a mid-mesiodistal plane through the implant center for buccal and lingual gingival volume (total buccolingual volume; BLV, buccal volume; BV and lingual volume; LV).

  Day 0 - month 3

Secondary Outcomes (1)

• The Functional Implant Prosthodontics Score

  Day 0 - month 3

Other Outcomes (1)

• Numerical rating scale

  Day 0 - 2 hours- 24 hours

Study Arms (2)

immediate implant placement with customized composite healing abutment

ACTIVE COMPARATOR

* 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).

Other: immediate implant placement with customized PEEK healing abutment

immediate implant placement with customized PEEK healing abutment

EXPERIMENTAL

* 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.

Other: immediate implant placement with customized PEEK healing abutment

Interventions

immediate implant placement with customized PEEK healing abutment OTHER

* 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.

immediate implant placement with customized PEEK healing abutment; immediate implant placement with customized composite healing abutment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Marwa Helal

Cairo, 02, Egypt

RECRUITING

Central Study Contacts

Marwa Helal

CONTACT

01125141408; marwa.helal@dentistry.cu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 16, 2024
• Study Start: June 1, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3- months

Locations

EG (1)