Soft Tissue Response and IL-1β Levels Around CAD/CAM-Milled vs 3D-Printed PMMA Healing Abutments
NCT ID: NCT07287722
Last Updated: 2025-12-17
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
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ACTIVE_NOT_RECRUITING
NA
22 participants
INTERVENTIONAL
2025-11-23
2025-12-23
Brief Summary
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There are two ways to make these caps:
1. CAD/CAM-milled (carved from a solid block)
2. 3D-printed (built layer by layer using resin) The goal was to find out which type leads to healthier gum tissue. What the Researchers Did
* 22 dental implants in 22 patients were included.
* Each implant received one healing cap-either milled or 3D-printed.
* Patients were checked after 1 week, 2 weeks, and 4 weeks.
* The team measured:
* Gum inflammation
* Bleeding around the implant
* Plaque buildup
* Pocket depth around the implant
* Levels of an inflammatory marker called Interleukin-1β (IL-1β) in the gum fluid (higher levels mean more inflammation).
* Surface smoothness and material quality of each type of healing cap. What the Study Found
* Gum inflammation and bleeding were higher with 3D-printed caps, especially at week 4.
* IL-1β levels were much higher around 3D-printed caps-showing more inflammation.
* Both types had some increase in plaque and probing depth over time, but there was no major difference between groups.
* The milled caps had smoother surfaces and better material quality, which may have helped reduce irritation and inflammation.
* 3D-printed caps were rougher and had lower polymerization (more leftover monomers), which may trigger soft-tissue irritation.
What This Means
* CAD/CAM-milled PMMA healing caps appear to be safer and healthier for gum healing around dental implants.
* They may help reduce early inflammation, support better tissue health, and more predictably shape the gums during healing.
Why This Matters for Patients
* Using a smoother, better-finished healing cap may lower the risk of early gum inflammation.
* Healthier soft tissue around an implant leads to better long-term implant stability.
* This information can help dentists choose the best healing cap for optimal healing.
Study Timeframe
• The follow-up was 4 weeks, so results focus on early healing. More research is needed to know long-term differences.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CAD/CAM-Milled PMMA Healing Abutment
Participants receive a customized PMMA healing abutment manufactured using CAD/CAM milling from a pre-polymerized PMMA block. The abutment is attached to the implant at second-stage surgery to guide soft-tissue healing.
CAD/CAM-Milled PMMA Healing Abutment
A customized healing abutment fabricated by subtractive CAD/CAM milling from a pre-polymerized PMMA block. Milling produces a highly polished, low-porosity surface with a high degree of polymerization. The abutment is connected to a Ti-base and placed at second-stage surgery to shape peri-implant soft tissues.
3D-Printed PMMA Healing Abutment
Participants receive a customized PMMA healing abutment manufactured using 3D printing from a light-cured PMMA resin, followed by post-processing and UV curing. The abutment is attached to the implant at second-stage surgery.
3D-Printed PMMA Healing Abutment
A customized healing abutment produced by additive manufacturing (3D printing) using a light-cured PMMA resin. The abutment is printed layer-by-layer, washed in isopropyl alcohol, UV-cured, finished, and polished. This manufacturing technique results in a different surface texture and polymerization level compared to milled PMMA. The abutment is attached to a Ti-base and placed at second-stage surgery.
Interventions
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CAD/CAM-Milled PMMA Healing Abutment
A customized healing abutment fabricated by subtractive CAD/CAM milling from a pre-polymerized PMMA block. Milling produces a highly polished, low-porosity surface with a high degree of polymerization. The abutment is connected to a Ti-base and placed at second-stage surgery to shape peri-implant soft tissues.
3D-Printed PMMA Healing Abutment
A customized healing abutment produced by additive manufacturing (3D printing) using a light-cured PMMA resin. The abutment is printed layer-by-layer, washed in isopropyl alcohol, UV-cured, finished, and polished. This manufacturing technique results in a different surface texture and polymerization level compared to milled PMMA. The abutment is attached to a Ti-base and placed at second-stage surgery.
Eligibility Criteria
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Inclusion Criteria
* Presence of one osseointegrated dental implant placed at least 8 weeks prior to second-stage surgery
* Adequate zone of attached keratinized gingiva (\> 1 mm) around the implant site
* Good general health and able to provide informed consent
* Willing and able to attend all follow-up visits (1, 2, and 4 weeks)
Exclusion Criteria
* Presence of systemic diseases that may affect healing (e.g., autoimmune conditions, uncontrolled diabetes, immunosuppressive disorders)
* Oral inflammatory conditions or active oral infections
* History of head and neck radiation therapy or chemotherapy
* Use of corticosteroids or antibiotics within the last 3 months
* Parafunctional habits (e.g., bruxism)
* Pregnant or breastfeeding individuals
* Implants with insufficient attached gingiva or poor oral hygiene maintenance
25 Years
65 Years
ALL
Yes
Sponsors
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Ali Hassan Eid Toto
OTHER
Responsible Party
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Ali Hassan Eid Toto
MSC Candidate in periodontology department Alexandria university
Locations
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Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Countries
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Other Identifiers
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AlexandriaUali
Identifier Type: -
Identifier Source: org_study_id