Immediate Implant Placement With Different Materials of Customized Healing Abutment for Guiding Peri-implant Soft Tissue Healing in Posterior Teeth
NCT ID: NCT06645444
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
20 participants
INTERVENTIONAL
2025-06-01
2025-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Papilla Index Around Immediate Mandibular Molar Implants Using Customized Healing Abutment Versus Submerged Healing
NCT04449302
Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment
NCT06040788
Using Sealing Socket Abutment Technique With Immediate Implant in the Mandibular Molars
NCT03667261
Influence of Abutment Angulation on Implant Failure in Immediately Placed and Restored Implants in the Esthetic Zone Using Computer Aided Surgical Guides: RCT
NCT03243695
Evaluation of Peri-Implant Tissues of Different Implant Assisted Overdentures
NCT06647199
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
immediate implant placement with customized composite healing abutment
* 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).
immediate implant placement with customized PEEK healing abutment
* 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
* 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
* 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
immediate implant placement with customized PEEK healing abutment
* 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marwa Helal
Lecturer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Marwa Helal
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
591024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.